Scientific recommendations on classification of advanced therapy medicinal products

Update: The list of medicines that the CAT has assessed and recommended classifying as ATMPs or not since March 2019 is available below. EMA updates the list on a quarterly basis.

ATMP classifications granted before March 2019 are available separately in the archive below.

Reference Number: EMA/140033/2021

English (EN) (151.1 KB - XLSX)

First published: 25/05/2023Last updated: 13/02/2024

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Scientific recommendations on classification of advanced therapy medicinal products (April 2019 - December 2020)

Reference Number: EMA/321214/2021

English (EN) (107.73 KB - XLSX)

First published: 10/11/2021

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Product description	Therapeutic area	Classification	Date of adoption of recommendation
Scientific recommendation on classification of advanced therapy medicinal products: Recombinant adeno-associated virus serotype 8 containing a codon optimised copy of the cDNA encoding human Retinitis Pigmentosa GTPase Regulator	Intended for the treatment of X-linked retinitis pigmentosa	Gene therapy medicinal product	28/03/2019
Scientific recommendation on classification of advanced therapy medicinal products: Ex-vivo expanded allogeneic bone marrow derived mesenchymal stromal cells	Intended for the treatment of graft-versus-host disease	Somatic cell therapy medicinal product	28/03/2019
Scientific recommendation on classification of advanced therapy medicinal products: DNA plasmid vector encoding human IL-12	Intended for the treatment of advanced melanoma	Gene therapy medicinal product	28/03/2019
Scientific recommendation on classification of advanced therapy medicinal products: Recombinant adeno-associated viral vector containing a human micro-dystrophin gene	Intended for the treatment of patients with Duchenne muscular dystrophy who have a confirmed mutation of the DMD gene	Gene therapy medicinal product	28/03/2019
Scientific recommendation on classification of advanced therapy medicinal products: In vitro transcribed messenger RNA molecules encoding IFNα2b, IL-12, IL-15sushi and GM-CSF cytokines	Intended for the treatment of solid tumours	Gene therapy medicinal product	28/03/2019
Scientific recommendation on classification of advanced therapy medicinal products: Allogeneic, ex vivo expanded, umbilical cord blood-derived, haematopoietic CD34+ progenitor cells, and allogeneic, non-expanded, umbilical cord blood-derived...	Haematopoietic reconstitution of patients who are medically indicated for allogeneic haematopoietic stem cell transplantation	Tissue engineered product	28/03/2019
Scientific recommendation on classification of advanced therapy medicinal products: Autologous skeletal muscle derived cells attached to poly(DL-lactide-co-glycolide) microparticles	Intended for the treatment of faecal incontinence and anorectal malformation	Tissue engineered product (combined)	28/03/2019
Stromal vascular fraction	Intended for the treatment of congenital adrenal hyperplasia 21-hydroxylase deficiency caused by mutations in the CYP21a2 gene	Gene therapy medicinal product	28/03/2019
Scientific recommendation on classification of advanced therapy medicinal products: Recombinant adeno-associated virus type rh10 containing a transgene that encodes a microRNA targeting SOD1 messenger RNA under the control of an H1 promoter	Intended for the treatment of amyotrophic lateral sclerosis due to mutations in SOD1	Gene therapy medicinal product	06/02/2019
Scientific recommendation on classification of advanced therapy medicinal products: Cultured autologous adipose-derived stem cells	Intended for urinary diversion in patients requiring radical cystectomy for the treatment of bladder cancer	Tissue engineered product (combined)	06/02/2019
Scientific recommendation on classification of advanced therapy medicinal products: Recombinant adeno-associated virus serotype 9 containing a human α-L-iduronidase gene cassette	Intended for the treatment of mucopolysaccharidosis type I	Gene therapy medicinal product	06/02/2019
Scientific recommendation on classification of advanced therapy medicinal products: Autologous CD34+ cells transduced with a lentiviral vector encoding for the CD18 β-subunit of human β2 Integrin	Intended for the treatment of paediatric brain damage, hypoxic-ischemic encephalopathy, cerebral palsy	Tissue engineered product	06/02/2019
Scientific recommendation on classification of advanced therapy medicinal products: Adeno-associated virus serotype 5 encoding human retinal guanylate cyclase 1 gene	Intended for the treatment of inherited retinal disease caused by biallelic mutations in human retinal guanylate cyclase 1 gene, including Leber congenital amaurosis type 1	Gene therapy medicinal product	06/02/2019
Scientific recommendation on classification of ATMP: Autologous viable adipose-derived regenerative cells extracted from human subcutaneous fat from liposuction aspirates obtained by enzymatic isolation (using a proprietary system from manufacturer 2)	Intended for the treatment of burn scars	Tissue engineered product	22/02/2019
Scientific recommendation on classification of ATMP: Autologous viable adipose-derived regenerative cells extracted from human subcutaneous fat from liposuction aspirates obtained by enzymatic isolation (using a proprietary system from manufacturer 1)	Intended for the treatment of burn scars	Tissue engineered product	22/02/2019
Scientific recommendation on classification of advanced therapy medicinal products: Autologous viable adipose-derived regenerative cells extracted from human subcutaneous fat from liposuction aspirates	Intended for the treatment of burn scars	Tissue engineered product	06/02/2019
Scientific recommendation on classification of ATMP: Autologous viable adipose-derived regenerative cells extracted from human subcutaneous fat from liposuction aspirates obtained by enzymatic isolation (using a proprietary system from manufacturer 2)	Intended for the treatment of progressive hemifacial atrophy (Parry-Romberg syndrome)	Tissue engineered product	22/02/2019
Scientific recommendation on classification of ATMP: Autologous viable adipose-derived regenerative cells extracted from human subcutaneous fat from liposuction aspirates obtained by enzymatic isolation (using a proprietary system from manufacturer 1)	Intended for the treatment of progressive hemifacial atrophy (Parry-Romberg syndrome)	Tissue engineered product	22/02/2019
Scientific recommendation on classification of advanced therapy medicinal products: Autologous viable adipose-derived regenerative cells extracted from human subcutaneous fat from liposuction aspirates	Intended for the treatment of progressive hemifacial atrophy (Parry-Romberg syndrome)	Not an advanced therapy medicinal product	06/02/2019
Scientific recommendation on classification of advanced therapy medicinal products: Allogeneic cultured postnatal thymus tissue-derived product	Intended for the treatment of immune reconstitution in patients with congenital athymia	Tissue engineered product	20/12/2018
Scientific recommendation on classification of advanced therapy medicinal products: Autologous CD34+ cells transduced with a lentiviral vector encoding for the CD18 β-subunit of human β2 Integrin	Intended for the treatment of severe leukocyte adhesion deficiency type I	Gene therapy medicinal product	20/12/2018
Scientific recommendation on classification of advanced therapy medicinal products: Allogeneic natural killer cells expanded in vitro	Intended for the treatment of multiple myeloma	Somatic cell therapy medicinal product	20/12/2018
Scientific recommendation on classification of advanced therapy medicinal products: DNA delivery vector with similar structure-function than bacteriophage capsids	Intended for the treatment of infections mediated by Shiga-Toxin producing Escherichia coli	Gene therapy medicinal product	20/12/2018
Scientific recommendation on classification of advanced therapy medicinal products: Recombinant adeno-associated virus (AAV), serotype 1 containing a transgene that encodes a microRNA targeting huntingtin messenger RNA	Intended for the treatment of Huntington’s disease	Gene therapy medicinal product	19/11/2018
Scientific recommendation on classification of advanced therapy medicinal products: Allogeneic haematopoietic stem and progenitor cells treated ex vivo with a fusion protein	Intended for the treatment of severe combined immunodeficiency	Somatic cell therapy medicinal product	19/11/2018
Scientific recommendation on classification of advanced therapy medicinal products: Human bone marrow derived allogeneic mesenchymal stem cells expressing human alpha-1 antitrypsin	Intended for the treatment of steroid refractory acute Graft-versus-Host-Disease (GvHD), grades II-IV	Gene therapy medicinal product	19/11/2018
Scientific recommendation on classification of advanced therapy medicinal products: Allogeneic human Wharton’s jelly-derived mesenchymal stem cells seeded onto decellularized dermal scaffold	Intended for the treatment of epidermolysis bullosa	Tissue engineered product	19/11/2018
Scientific recommendation on classification of advanced therapy medicines: Allogeneic Epstein-Barr Virus specific cytotoxic T lymphocytes	Intended for the treatment of refractory/relapsed EBV-associated post-transplant lymphoproliferative disease	Somatic cell therapy medicinal product	18/10/2018
Scientific recommendation on classification of advanced therapy medicinal products: In vitro cultured autologous mesenchymal stem cells isolated from bone marrow	Intended for the treatment of ischemic stroke	Tissue engineered medicinal product	18/10/2018
Scientific recommendation on classification of advanced therapy medicinal products: In vitro cultured autologous mesenchymal stem cells isolated from bone marrow	Intended for regeneration of cartilage, ligaments (Anterior cruciate ligament) and bone and muscle defects	Tissue engineered medicinal product	18/10/2018
Scientific recommendation on classification of advanced therapy medicinal products: Codon-optimized mRNA that will be translated to functional human cystic fibrosis transmembrane conductance regulator protein after cellular uptake	Intended for treatment of cystic fibrosis	Gene therapy medicinal product	18/10/2018
Scientific recommendation on classification of advanced therapy medicinal products: Recombinant adeno-associated virus serotype 9 vector encoding the soluble lysosomal enzyme TPP1	Intended for treatment of CLN2 disease	Gene therapy medicinal product	18/10/2018
Organ donor derived CD34+ haematopoietic stem cells and a defined dose of donor-derived CD3+ T-cells	Intended for the prevention of graft rejection in recipients of HLA-matched living donor kidney transplant recipients	Not an advanced therapy medicinal product	20/09/2018
Recombinant adeno-associated viral vector serotype 9 (AAV9) encoding a short hairpin RNA and a codon-optimised wildtype protein	Intended for the treatment of oculopharyngeal muscular dystrophy	Gene therapy medicinal product	20/09/2018
Stromal vascular fraction	Intended for the regeneration of epithelial fibrosis as a result of vulvar lichen sclerosis	Not an advanced therapy medicinal product	20/09/2018
Scientific recommendation on classification of advanced therapy medicinal products: Non-replicating recombinant adeno-associated virus carrying a fragment of the Channelrhodopsin-2 (ChR2) protein	Intended for the treatment of retinitis pigmentosa	Gene therapy medicinal product	20/07/2018
Scientific recommendation on classification of advanced therapy medicinal products: Autologous suspension of blood-derived endothelial and hematopoietic stem/progenitor cells	Intended for the treatment of No-Option Patients with Peripheral Arterial Disease (PAD) and Critical Limb Ischemia (CLI)	Tissue engineered product	20/07/2018
Scientific recommendation on classification of advanced therapy medicinal products: Four in vitro transcribed mRNA molecules each encoding one tumour antigen	Intended for the treatment of malignant melanoma	Gene therapy medicinal product	20/07/2018
Scientific recommendation on classification of advanced therapy medicinal products: In vitro transcribed patient-specific mRNA molecule encoding neo-epitopes that are specifically derived from tumour tissue	Intended for the treatment of locally advanced or metastatic tumours	Gene therapy medicinal product	20/07/2018
Scientific recommendation on classification of advanced therapy medicinal products: Homogenate of antlerogenic stem cells	Intended for the therapeutic support in spinal cord injury	Tissue engineered product	20/07/2018
Scientific recommendation on classification of advanced therapy medicinal products: Recombinant adeno-associated viral vector capsid containing the human iduronate-2-sulfatase (hIDS) expression cassette	Intended for the treatment of mucopolysaccharidosis type II (Hunter syndrome)	Gene therapy medicinal product	5/07/2018
Scientific recommendation on classification of advanced therapy medicinal products: Codon-optimized human ornithine transcarbamylase messenger ribonucleic acid	Intended for the treatment of ornithine transcarbamylase deficiency	Gene therapy medicinal product	5/07/2018
Scientific recommendation on classification of advanced therapy medicinal products: Dystrophin expressing chimeric cells obtained by ex vivo fusion of two normal allogeneic human myoblasts	Intended for the treatment of Duchenne muscular dystrophy	Tissue engineered product	5/07/2018
Scientific recommendation on classification of advanced therapy medicinal products: Dystrophin expressing chimeric cells obtained by ex vivo fusion of defective myoblasts from a Duchenne Muscular Dystrophy patient with normal myoblasts	Intended for the treatment of Duchenne muscular dystrophy	Tissue engineered product	5/07/2018
Scientific recommendation on classification of advanced therapy medicinal products: Autologous anti-BCMA (B-cell maturation antigen) chimeric antigen receptor (CAR) T-cells	Intended for the treatment of patients with relapsed or refractory multiple myeloma	Gene therapy medicinal product	5/07/2018
Scientific recommendation on classification of advanced therapy medicinal products: Homogenate of antlerogenic stem cells - Tissue engineered product	Intended for the treatment of recurrent corneal erosion syndrome	Tissue engineered product	5/07/2018
Scientific recommendation on classification of advanced therapy medicinal products: Cultured human olfactory ensheathing cells and olfactory nerve fibroblasts	Intended for the treatment of complete spinal cord injuries	Tissue engineered product	22/06/2018
Scientific recommendation on classification of advanced therapy medicinal products: Autologous CD34+ cells transduced with a lentiviral vector containing the FANCA gene	Intended for the treatment of Fanconi Anemia type A patients	Gene therapy medicinal product	05/06/2018
Scientific recommendation on classification of advanced therapy medicinal products: Adeno-associated virus (AAV) vector encoding genes from an algae channel rhodopsin	Intended for the treatment of retinitis pigmentosa	Gene therapy medicinal product	30/05/2016
Scientific recommendation on classification of advanced therapy medicinal products: Autologous adipose cells	Intended for the treatment of anal fistula	Tissue engineered product	26/04/2018
Scientific recommendation on classification of advanced therapy medicinal products: Exosomes carrying recombinant mRNA encoding for the cystic fibrosis transmembrane conductance regulator protein and microRNA-17	Intended for the treatment of cystic fibrosis	Gene therapy medicinal product	26/04/2018
Scientific recommendation on classification of advanced therapy medicinal products: Human foetal neural stem cells	Intended for the treatment of amyotrophic lateral sclerosis	Tissue engineered product	26/04/2018
Scientific recommendation on classification of advanced therapy medicinal products: Human foetal neural stem cells	Intended for the treatment of spinal cord injury	Tissue engineered product	26/04/2018
Scientific recommendation on classification of advanced therapy medicinal products: allogenic mesenchymal stem cells isolated from umbilical cord	Intended for the treatment of multiple sclerosis	Tissue engineered product	28/03/2018
Scientific recommendation on classification of advanced therapy medicinal products: autologous bone marrow-derived mesenchymal stem cells	Intended for the treatment of multiple sclerosis	Tissue engineered product	28/03/2018
Scientific recommendation on classification of advanced therapy medicinal products: allogeneic human neural stem cells derived from foetal central nervous system	Intended for the treatment of traumatic brain injury (e.g. coma, minimally conscious state, persistent vegetative state) and stroke	Tissue engineered product	28/03/2018
Scientific recommendation on classification of advanced therapy medicinal products: autologous bone marrow-derived human mesenchymal stem cells	Intended for the treatment of articular cartilage damage and tendon injuries	Tissue engineered product	28/03/2018
Scientific recommendation on classification of advanced therapy medicinal products: ex vivo fused autologous human bone marrow-derived mesenchymal stem cell with allogenic human myoblastScientific recommendation on classification of advanced therapy medicinal products: ex vivo fused autologous human bone marrow-derived mesenchymal stem cell with allogenic human myoblast	Intended for the treatment of Duchenne muscular dystrophy	Tissue engineered product	28/03/2018
Scientific recommendation on classification of advanced therapy medicinal products: allogeneic pancreatic islets encapsulated by elastin-like recombinamers	Intended for the treatment of severe forms of type 1 diabetes	Not an advanced therapy medicinal product	28/03/2018
Scientific recommendation on classification of advanced therapy medicinal products: autologous enriched CD31+ cell fraction from peripheral blood	Intended for the surgical care of bone fractures	Not an advanced therapy medicinal product	28/03/2018
Scientific recommendation on classification of advanced therapy medicinal products: expanded autologous auricular chondrocytes	Intended for repair of microtia	Tissue engineered product	22/02/2018
Scientific recommendation on classification of advanced therapy medicinal products: Autologous dendritic cells, pulsed with allogeneic tumour cell lysate	Intended for the treatment of malignant mesothelioma	Somatic cell therapy medicinal product	29/01/2018
Scientific recommendation on classification of advanced therapy medicinal products: Allogeneic mesenchymal stem cells suspended in cell supernatant	Intended for the treatment of osteoarthritis	Tissue engineered product	29/01/2018
Scientific recommendation on classification of advanced therapy medicinal products: Autologous bone-marrow derived CD34+ cells	Intended for improvement of neurologic function in patients with non-lacunar acute ischemic stroke infarction	Tissue engineered product	20/12/2017
Scientific recommendation on classification of advanced therapy medicinal products: Autologous adipose-derived stem cells seeded on a collagen matrix scaffold	Intended for the treatment of cancer-related lymphedema in breast cancer patients	Tissue engineered product (combined)	20/12/2017
Scientific recommendation on classification of advanced therapy medicinal products: CD1c (BDCA-1)+ myeloid dendritic cells	Intended for the treatment of advanced, pre-treated solid tumours with injectable metastases	Not an advanced therapy medicinal product	08/12/2017
Scientific recommendation on classification of advanced therapy medicinal products: Cultured human retinal pigment epithelial cells genetically modified to express human factor IX protein	Intended for the treatment of Hemophilia B	Gene therapy medicinal product (combined)	09/11/2017
Scientific recommendation on classification of advanced therapy medicinal products: Allogenic adipose-derived stem cells differentiated in vitro towards the cardiovascular lineageScientific recommendation on classification of advanced therapy medicinal products: Allogenic adipose-derived stem cells differentiated in vitro towards the cardiovascular lineageScientific recommendation on classification of advanced therapy medicinal products: Allogenic adipose-derived stem cells differentiated in vitro towards the cardiovascular lineage	Intended to restore cardiac function post myocardic infarction	Tissue engineered product (combined)	17/10/2017
Scientific recommendation on classification of advanced therapy medicinal products: Recombinant adeno-associated virus serotype 2/1 vector encoding human Î²-hexosaminidase alpha and beta subunits?Scientific recommendation on classification of advanced therapy medicinal products: Recombinant adeno-associated virus serotype 2/1 vector encoding human Î²-hexosaminidase alpha and beta subunits	Intended for treatment of Tay-Sachs disease and Sandhoff disease	Gene therapy medicinal product	17/10/2017
Scientific recommendation on classification of advanced therapy medicinal products: Adeno-associated viral vector serotype 8 containing the human low-density lipoprotein receptor (LDLR) gene	Intended for treatment of homozygous familial hypercholesterolemia caused by mutations in the LDLR gene	Gene therapy medicinal product	17/10/2017
Scientific recommendation on classification of advanced therapy medicinal products: Full-thickness human skin substitute composed of an epidermal layer of fully-stratified human keratinocytes and a collagen-rich dermal e...	Intended for treatment of patients with acute complex skin loss	Tissue engineered product	17/10/2017
Scientific recommendation on classification of advanced therapy medicinal products: Freshly isolated autologous CD34+	Intended for regeneration of soft and hard tissues of temporomandibular joints	Tissue engineered product	17/10/2017
Scientific recommendation on classification of advanced therapy medicinal products: Autologous dental pulp stem cells	Intended for regeneration of soft and hard tissues of temporomandibular joints	Tissue engineered product	17/10/2017
Scientific recommendation on classification of advanced therapy medicinal products: Cultured dental pulp stem cells	Intended for regeneration of soft and hard tissues of temporomandibular joints	Tissue engineered product	17/10/2017
Scientific recommendation on classification of advanced therapy medicinal products: Allogeneic human glial-restricted precursors	Intended for the treatment of amyotrophic lateral sclerosis	Tissue engineered medicinal product	14/09/2017
Scientific recommendation on classification of advanced therapy medicinal products: Allogeneic human glial-restricted precursors	Intended for the treatment of spinal cord injuries (four-limb paralysis, paresis)	Tissue engineered medicinal product	14/09/2017
Scientific recommendation on classification of advanced therapy medicinal products: Nuclease resistant, synthetic double-stranded small interfering RNA (siRNA)	Intended for the treatment of hepatic fibrosis	Not an advanced therapy medicinal product	14/09/2017
Scientific recommendation on classification of advanced therapy medicinal products: Messenger RNAs (mRNAs) encoding immunostimulatory proteins caTLR4, CD40L and CD70 and tumour associated antigens (TAA) tyrosinase, gp100...	Intended for the treatment of melanoma	Gene therapy medicinal product	14/09/2017
Scientific recommendation on classification of advanced therapy medicinal products: Viable chondrocytes cultured within a 3D hydrogel	Intended for the treatment of articular cartilage defects of the knee	Tissue engineered product (combined)	14/09/2017
Scientific recommendation on classification of advanced therapy medicinal products: Stromal vascular fraction cells	Indicated to relieve symptoms of osteoarthritis	Somatic cell therapy medicinal product	30/06/2017
Scientific recommendation on classification of advanced therapy medicinal products: Human autologous keratinocytes	Intended for the treatment of burns and chronic, severe wounds	Tissue engineered medicinal product	30/06/2017
Scientific recommendation on classification of advanced therapy medicinal products: Human autologous chondrocytes	Intended for repair of single symptomatic cartilage defect of the knee or ankle	Tissue engineered product	30/06/2017
Scientific recommendation on classification of advanced therapy medicinal products: Human umbilical cord blood-derived mesenchymal stem cells	Intended for treatment of atopic dermatitis	Somatic cell therapy medicinal product	30/06/2017
Scientific recommendation on classification of advanced therapy medicinal products: Autologous adipose tissue-derived mesenchymal stem cells	Intended for chronic wounds healing (venous leg ulcers, post-traumatic wounds)	Somatic cell therapy medicinal product	19/07/2017
Scientific recommendation on classification of advanced therapy medicinal products: Allogeneic haptenized, stimulated and irradiated non-proliferative colorectal tumour whole cells derived from 3 colorectal cell lines	Intended for the treatment of colorectal cancer	Somatic cell therapy medicinal product	12/05/2017
Scientific recommendation on classification of advanced therapy medicinal products: Autologous human adipose perivascular stromal cells genetically modified to secrete soluble TRAIL ligand	Intended for the treatment of TRAIL-sensitive cancers such as Ewing sarcoma and pancreatic ductal adenocarcinoma	Gene therapy medicinal product	06/06/2017
Scientific recommendation on classification of advanced therapy medicinal products: Replication incompetent adenoviral vector encoding Interleukin 12 with activator ligand	Intended for the treatment of patients with recurrent or progressive glioblastoma multiforme	Gene therapy medicinal product	06/06/2017
Scientific recommendation on classification of advanced therapy medicinal products: Allogeneic human mesenchymal stem cells derived from Wharton’s jelly tissue of umbilical cord	Intended for the treatment ofChronic obstructive pulmonary disease (COPD)	Tissue engineered product	06/06/2017
Scientific recommendation on classification of advanced therapy medicinal products: Autologous adipose derived mesenchymal stem cells, freshly isolated	Intended for the treatment ofautoimmune drug resistant epilepsy	Somatic cell therapy medicinal product	06/06/2017
Scientific recommendation on classification of advanced therapy medicinal products: Cultured allogenic Wharton’s jelly derived mesenchymal stem cells	Intended for the treatment ofmyotrophic lateral sclerosis	Tissue engineered product	06/06/2017
Scientific recommendation on classification of advanced therapy medicinal products: Cultured autologous adipose derived mesenchymal stem cells	Intended for the treatment ofautoimmune drug resistant epilepsy	Somatic cell therapy medicinal product	06/06/2017
Scientific recommendation on classification of advanced therapy medicinal products: Cultured autologous adipose derived regenerative mesenchymal stem cells	Intended for the treatment ofautoimmune drug resistant epilepsy	Somatic cell therapy medicinal product	06/06/2017
Scientific recommendation on classification of advanced therapy medicinal products: Cultured autologous Wharton’s jelly derived mesenchymal stem cells	Intended for the treatment of amyotrophic lateral sclerosis	Tissue engineered medicinal product	16/06/2017
Scientific recommendation on classification of advanced therapy medicinal products: Recombinant adeno-associated virus (AAV) pseudotyped with viral capsid from serotype 5 which holds a construct that contains two guide r...	Intended for the treatment ofpatients aged 3 years and older with Leber Congenital Amaurosis type 10 (LCA10) caused by a homozygous or compound heterozygous intron 26 mutation, c.2991+1655 A&gtG, in the CEP290 gene	Gene therapy medicinal product	06/06/2017
Scientific recommendation on classification of advanced therapy medicinal products: Allogeneic suspension of unexpanded and uncultured human amniotic fluid-derived cells	Intended for the treatment of chronic, non-healing wounds	Tissue engineered product	06/06/2017
Scientific recommendation on classification of advanced therapy medicinal products: Human autologous stromal vascular fraction (SVF)	Intended for the treatment of articular cartilage and bone defects	Tissue engineered medicinal product	16/06/2017
Scientific recommendation on classification of advanced therapy medicinal products: Human autologous adipose-derived stromal/stem Cells (ADSCs)	Intended for the treatment of articular cartilage and bone defects	Tissue engineered medicinal product	16/06/2017
Scientific recommendation on classification of advanced therapy medicinal products: Human cultured dermal fibroblasts and human epidermal keratinocytes	Intended for the treatment of partial deep dermal and full thickness burn wounds	Tissue engineered product	06/06/2017
Scientific recommendation on classification of advanced therapy medicinal products: Resorbable, viscoelastic matrix	The classification request was for the matrix prior to combination with the cells. As such, no medical claim can be attributed to the matrix on its own which serves as a temporary resorbable 3-dimensional matrix when combined with cells. Over time this matrix is resorbed and replaced with natural extracellular matrix	Not an advanced therapy medicinal product	06/06/2017
Scientific recommendation on classification of advanced therapy medicinal products: genetically modified oncolytic adenovirus coated with oligopeptide-end modified Poly (Î²-amino) esters	Intended for the treatment of pancreatic cancer	Gene therapy medicinal product	29/03/2017
Scientific recommendation on classification of advanced therapy medicinal products: natural killer cells derived from human induced pluripotent stem cells transduced to express high-affinity non-cleavable CD16 (hnCD16) F...	Intended for the treatment of advanced solid tumour malignancies that have failed available approved therapies	Gene therapy medicinal product	19/04/2017
Scientific recommendation on classification of advanced therapy medicinal products: allogeneic human mesenchymal stem cells derived from umbilical cord	Intended for the treatment of intervertebral disc degeneration	Tissue engineered medicinal product	29/03/2017
Scientific recommendation on classification of advanced therapy medicinal products: non-replicating recombinant Adeno associated virus (rAAV8), expressing the human UGT1A1 gene	Intended for the treatment of Crigler-Najjar syndrome	Gene therapy medicinal product	29/03/2017
Scientific recommendation on classification of advanced therapy medicinal products: autologous bone marrow derived mesenchymal stem cells	Intended for the treatment of coma (traumatic brain injury, stroke)	Somatic cell therapy medicinal product	29/03/2017
Scientific recommendation on classification of advanced therapy medicinal products: banked allogenic leukocytes	Intended for the treatment of metastatic Pancreatic Ductal Adeno Carcinoma	Somatic cell therapy medicinal product	29/03/2017
Scientific recommendation on classification of advanced therapy medicinal products: viable genetically engineered ARPE-19 cells of human origin secreting glucose-binding fluorescent biosensor protein	Intended for adjunct glucose monitoring in diabetes patients	Gene therapy medicinal product	29/03/2017
Scientific recommendation on classification of advanced therapy medicinal products: autologous tumour-infiltrating lymphocytes	Intended for the treatment of metastatic melanoma	Somatic cell therapy medicinal product	23/02/2017
Scientific recommendation on classification of advanced therapy medicinal products: Genetically engineered AAV8 that lacks all of the viral protein-coding sequences and encodes a human MTM1 complementary DNA	Intended for the treatment of X-linked Myotubular Myopathy	Gene therapy medicinal product	27/01/2017
Scientific recommendation on classification of advanced therapy medicinal products: In vitro transcribed mRNA sequences encoding six non-small cell lung cancer (NSCLC) associated antigensScientific recommendation on classification of advanced therapy medicinal products: In vitro transcribed mRNA sequences encoding six non-small cell lung cancer (NSCLC) associated antigens	Intended for the treatment of non-small cell lung cancer	Gene therapy medicinal product	27/01/2017
Scientific recommendation on classification of advanced therapy medicinal products: mRNA sequence encoding the wild type human OX40L protein	Intended for the treatment of solid tumours	Gene therapy medicinal product	27/01/2017
Scientific recommendation on classification of advanced therapy medicinal products: Allogeneic bone marrow derived mesenchymal stem cells	Intended for the treatment of the acute Graft versus Host Disease grades III and IV and extensive chronic GvHD resistant to the first line of treatment	Somatic cell therapy medicinal product	27/01/2017
Scientific recommendation on classification of advanced therapy medicinal products: Allogeneic cytomegalovirus-specific cytotoxic T lymphocytes	Intended for the treatment of Cytomegalovirus-associated viraemia or disease after allogeneic haematopoietic cell transplant or solid organ transplant after failure of at least two different antiviral therapies	Somatic cell therapy medicinal product	27/01/2017
Scientific recommendation on classification of advanced therapy medicinal products: Allogeneic Epstein-Barr Virus Cytotoxic T Lymphocytes	Intended for the treatment of Epstein-Barr Virus-associated Post Transplant Lymphoproliferative Disorder	Somatic cell therapy medicinal product	30/05/2016
Scientific recommendation on classification of advanced therapy medicinal products: Autologous ex vivo expanded regulatory T lymphocytes with the cell marker profile of CD3+, CD4+, CD25high, CD127-, FoxP3+	Intended for the treatment of Type 1 Diabetes Mellitus	Somatic cell therapy medicinal product	30/05/2016
Scientific recommendation on classification of advanced therapy medicinal products: Bone marrow derived lineage negative heterogenic stem and progenitor cells	Intended for treatment of amyotrophic lateral sclerosis in adults	Tissue engineered product	19/12/2016
Scientific recommendation on classification of advanced therapy medicinal products: Allogeneic bone marrow derived mesenchymal stem cells	Intended for the treatment of the acute Graft versus Host Disease grades III and IV resistant to the first line of treatment	Somatic cell therapy medicinal product	09/11/2016
Scientific recommendation on classification of advanced therapy medicinal products: Bone marrow-derived autologous non-haematopoietic stem cells	Intended for the treatment of multiple sclerosis	Tissue engineered product	13/10/2016
Scientific recommendation on classification of advanced therapy medicinal products: Autologous anti-BCMA CAR-T cells	Intended for the treatment of multiple myeloma and B cell lymphoma	Gene therapy medicinal product	13/10/2016
Scientific recommendation on classification of advanced therapy medicinal products: Wharton jelly derived allogeneic mesenchymal stem cells, cultured in vitroScientific recommendation on classification of advanced therapy medicinal products: Wharton jelly derived allogeneic mesenchymal stem cells, cultured in vitro	Intended for the treatment of acute myocardial infarction, chronic ischaemic heart failure, no-option critical limb ischaemia	Tissue engineered product	13/10/2016
Scientific recommendation on classification of advanced therapy medicinal products: Recombinant modified vaccinia virus ankara (MVA) containing genetic sequences coding for the human mucin 1 and the human interleukin 2Scientific recommendation on classification of advanced therapy medicinal products: Recombinant modified vaccinia virus ankara (MVA) containing genetic sequences coding for the human mucin 1 and the human interleukin 2Scientific recommendation on classification of advanced therapy medicinal products: Recombinant modified vaccinia virus ankara (MVA) containing genetic sequences coding for the human mucin 1 and the human interleukin 2	Intended for the treatment of advanced non-squamous non-small cell lung cancer (NSCLC)	Gene therapy medicinal product	13/10/2016
Scientific recommendation on classification of advanced therapy medicinal products: Autologous human adipose mesenchymal stromal cells, expanded in culture	Intended for cardiac repair	Tissue engineered product	13/10/2016
Scientific recommendation on classification of advanced therapy medicinal products: Autologous skin cell suspension	Intended for burn wound treatment, donor site treatment	Tissue engineered product	13/10/2016
Scientific recommendation on classification of advanced therapy medicinal products: A recombinant replicating vaccinia viral vector (rilimogene galvacirepvec) and a recombinant non-replicating fowlpox viral vector (rilim...Scientific recommendation on classification of advanced therapy medicinal products: A recombinant replicating vaccinia viral vector (rilimogene galvacirepvec) and a recombinant non-replicating fowlpox viral vector (rilim...Scientific recommendation on classification of advanced therapy medicinal products: A recombinant replicating vaccinia viral vector (rilimogene galvacirepvec) and a recombinant non-replicating fowlpox viral vector (rilim...Scientific recommendation on classification of advanced therapy medicinal products: A recombinant replicating vaccinia viral vector (rilimogene galvacirepvec) and a recombinant non-replicating fowlpox viral vector (rilim...Scientific recommendation on classification of advanced therapy medicinal products: A recombinant replicating vaccinia viral vector (rilimogene galvacirepvec) and a recombinant non-replicating fowlpox viral vector (rilim...	Intended for treatment of metastatic, castrate-resistant prostate cancer	Gene therapy medicinal product	13/10/2016
Living, genetically modified Lactobacillus reuteri bacteria, with a plasmid containing the gene for human CXCL12-1a with an inducible promoter; and an activating peptide	Intended for treatment of chronic skin wounds in diabetic patients	Gene therapy medicinal product	16/09/2016
Human autologous stromal vascular fraction cells and human autologous adipose-derived mesenchymal stem cells	Intended for treatment of cutis laxa senilis	Tissue engineered product	16/09/2016
Tumour selectively replicating oncolytic adenovirus expressing tumour necrosis factor alpha (TNFÎ±) and interleukin 2 (IL2)	Intended for treatment of metastatic melanoma and other solid tumours	Gene therapy medicinal product	16/09/2016
Autologous T-cells expressing a chimeric NKG2D receptor	Intended for treatment of various tumour types	Gene therapy medicinal product	16/09/2016
The product includes two active substances i.e. two plasmids encoding for synthetic, non-functional consensus E6 and E7 antigens of human papilloma virus types 16 and 18	Intended for treatment of HPV-16 and -18 related high-grade squamous intraepithelial lesions (HSIL) of the cervix and vulva	Gene therapy medicinal product	16/09/2016
Scientific recommendation on classification of advanced therapy medicinal products: ex-vivo cultured and expanded human cord blood progenitor cells	Intended for the treatment of patients undergoing hematopoietic stem cell transplantation	Tissue-engineered product	19/07/2016
Scientific recommendation on classification of advanced therapy medicinal products: recombinant adeno-associated viral vector serotype 8 (AAV8) encoding human glucose-6-phosphatase-Î± (G6Pase or G6PC)	Intended for the treatment of glycogen storage disease type Ia (von Gierke disease)	Gene therapy medicinal product	19/07/2016
Scientific recommendation on classification of advanced therapy medicinal products: recombinant adeno-associated viral vector serotype 2 encoding the human aromatic L-amino acid decarboxylase gene	Intended for the treatment of Parkinson's disease	Gene therapy medicinal product	19/07/2016
Scientific recommendation on classification of advanced therapy medicinal products: heterologous human adult liver-derived progenitor cells	Intended for the treatment of fibro-inflammatory liver diseases	Tissue-engineered product	19/07/2016
Scientific recommendation on classification of advanced therapy medicinal products: Autologous fibroblasts expanded in vitro	Intended for the treatment of scars of different aetiology (such as post-traumatic, post-surgical or outcomes of acne scars)	Tissue engineered product	15/07/2016
Scientific recommendation on classification of advanced therapy medicinal products: Four independent DNA plasmid vectors encoding HBV antigens and human interleukin-12	Intended for antigenic clearance of chronic hepatitis B virus infection	Not an advanced therapy medicinal product	15/07/2016
Autologous concentrated bone marrow	Intended for the treatment of critical limb ischemia without surgical option	Tissue engineered product	01/07/2016
Collagenase enzyme from Clostridium histolyticum	Not intended for in vivo use in humans: the enzyme is used in a single use device for the dissociation of human adipose tissue to separate stromal vascular fraction cells	Not an advanced therapy medicinal product	01/07/2016
Scientific recommendation on classification of advanced therapy medicinal products: Live attenuated Listeria monocytogenes transfected with plasmids encoding HPV fusion protein	Intended for the treatment of cervical cancer	Gene therapy medicinal product	01/07/2016
Scientific recommendation on classification of advanced therapy medicinal products: Allogenic bone marrow derived mesenchymal stem cells expanded in vitro	Intended for the treatment of acute Graft-versus-Host Disease grades III and IV resistant to first line treatment	Somatic cell therapy medicinal product	20/05/2016
Scientific recommendation on classification of advanced therapy medicinal products: Concentrate of autologous bone marrow-derived mononuclear cells (BM-MNC)	Intended for the treatment of chronic myocardial ischemia with left ventricular dysfunction	Tissue engineered product	20/05/2016
Scientific recommendation on classification of advanced therapy medicinal products: Live-attenuated, double-deleted Listeria monocytogenes expressing human mesothelin	Intended for the treatment of malignant non-small cell lung cancer	Gene therapy medicinal product	20/05/2016
Scientific recommendation on classification of advanced therapy medicinal products: Live-attenuated, double-deleted Listeria monocytogenes expressing prostate antigens	Intended for the treatment of malignant prostate cancer	Gene therapy medicinal product	20/05/2016
Scientific recommendation on classification of advanced therapy medicinal products: Autologous cultured fibroblasts	Intended for the treatment of tissue loss and to close chronic non-closing injuries (such as diabetic foot and venous ulcers), and treatment of acne scars	Tissue engineered product	20/05/2016
Scientific recommendation on classification of advanced therapy medicinal products: Extracellular matrix isolated from adipose tissue	Intended for the treatment of soft tissue damage (fistula-in-ano, trophic ulcers, burns), cartilage defects as well as large tissue damage after cancer resection	Not an advanced therapy medicinal product	20/05/2016
Scientific recommendation on classification of advanced therapy medicinal products: Autologous cultured adipose derived mesenchymal stem cells	Intended for the treatment of non-healing wounds, specifically in tissues derived from mesenchyme e.g. fistula-in-ano, bone and cartilage defects, burns, trophic ulcers	Tissue engineered product	20/05/2016
Scientific recommendation on classification of advanced therapy medicinal products: In vitro cultured autologous chondrocytes	Intended for the treatment of cartilage loss in knee-joint	Tissue engineered product	20/05/2016
Scientific recommendation on classification of advanced therapy medicinal products: Viable human autologous skin fibroblasts	Intended for filling of skin connective tissue loss (skin wounds)	Tissue engineered product	20/05/2016
Scientific recommendation on classification of advanced therapy medicinal products: Human autologous keratinocytes	Intended for the treatment of non-healing wounds, burns, trophic ulcers	Tissue engineered product	20/05/2016
Scientific recommendation on classification of advanced therapy medicinal products: In vitro cultured autologous muscle-derived stem cells	Intended for the treatment of faecal incontinence, treatment of urinary incontinence, treatment of skeletal muscle injury	Tissue engineered product	20/05/2016
Scientific recommendation on classification of advanced therapy medicinal products: In vitro cultured autologous melanocytes	Intended for the treatment of vitiligo	Tissue engineered product	20/05/2016
Scientific recommendation on classification of advanced therapy medicinal products: Mesenchymal stem cells isolated from autologous bone marrow	Intended for the treatment of children neurological diseases: children encephalopathy (Hypoxic–ischaemic encephalopathy, immune/autoimmune encephalopathy), children epilepsy and children spinal cord injury	Tissue engineered product	20/05/2016
Scientific recommendation on classification of advanced therapy medicinal products: Autologous human mesenchymal stem cells present in bone marrow cells suspension therapy medicinal products: Autologous human mesenchymal stem cells present in bone marrow cells suspension	Intended for the treatment of type 2 Diabetes Mellitus	Somatic cell therapy medicinal product	04/04/2016
Scientific recommendation on classification of advanced therapy medicinal products: Autologous stromal vascular fraction	Autologous lipofilling	CAT cannot conclude on the classification of this product	04/04/2016
Scientific recommendation on classification of advanced therapy medicinal products: DNA plasmid encoding for the extracellular domain of human TNFÎ± p55 receptor linked to the human IgG1 Fc domain	Intended for the treatment of refractory chronic non-infectious uveitis	Gene therapy medicinal product	04/04/2016
Scientific recommendation on classification of advanced therapy medicinal products: Autologous ex vivo expanded polyclonal CD4+CD25+CD127lo/-FOXP3+ regulatory T cells	Intended for the treatment of type 1 Diabetes Mellitus	Somatic cell therapy medicinal product	04/04/2016
Scientific recommendation on classification of advanced therapy medicinal products: Viable autologous adipose-derived regenerative cells	Autologous dermal filling	CAT cannot conclude on the classification of this product	04/04/2016
Human autologous stromal vascular fraction (SVF) cells and human autologous adipose-derived mesenchymal stem cells (ADSC) cells	Intended for the treatment of keloid scars	Tissue-engineered product	23/03/2016
Scientific recommendation on classification of advanced therapy medicinal products: Human burn eschar and debrided adipose tissue cells (suspension)	Intended for the treatment of burns, scars, non-healing wounds	Tissue engineered product	23/03/2016
Scientific recommendation on classification of advanced therapy medicinal products: Human burn eschar and debrided adipose tissue cells (sheet)	Intended for the treatment of burns, scars, non-healing wounds	Tissue engineered product	23/03/2016
Scientific recommendation on classification of advanced therapy medicinal products: Human burn eschar and debrided adipose tissue cells (on acellular amniotic matrix)	Intended for the treatment of burns, scars, non-healing wounds	Tissue engineered product	23/03/2016
Scientific recommendation on classification of advanced therapy medicinal products: Human burn eschar and debrided adipose tissue cells (on acellular dermal matrix)	Intended for the treatment of burns, scars, non-healing wounds	Tissue engineered product	23/03/2016
Adenovirus serotype 5 expressing the Core protein, the Polymerase protein and selected domains of the Envelope protein of Hepatitis B Virus	Intended for the treatment of chronic hepatitis B	Not an advanced therapy medicinal product	03/03/2016
Scientific recommendation on classification of advanced therapy medicinal products: co-culture of keratinocytes and mesenchymal stem cells isolated from human burn eschar and debrided adipose tissue cells, seeded onto ac...	Intended for the treatment of deep and extensive burns, chronic wounds and skin donor sites	Tissue-engineered product	03/03/2016
Scientific recommendation on classification of advanced therapy medicinal products: co-culture of keratinocytes and mesenchymal stem cells isolated from human burn eschar and debrided adipose tissue cells, seeded onto ac...	Intended for the treatment of deep and extensive burns, chronic wounds and skin donor sites	Tissue-engineered product	03/03/2016
Two irradiated allogeneic pancreatic tumour cell lines, genetically engineered to secrete human granulocyte macrophage-colony stimulating factor (GM-CSF)	Intended for the treatment of pancreatic cancer	Gene therapy medicinal product	03/03/2016
Ex vivo expanded autologous Epstein-Barr Virus specific T-cells derived from peripheral blood mononuclear cells	Intended for the treatment of Epstein-Barr Virus (EBV) positive malignancies	Somatic cell therapy medicinal product	03/03/2016
Adeno-associated virus serotype 2 based vector containing the human RPE65 gene expression cassette	Intended for the treatment of inherited retinal degeneration due to autosomal recessive RPE65 gene mutations	Gene therapy medicinal product	29/01/2016
Autologous blood-derived cells filtered to remove other blood components	Intended for the treatment of critical limb ischemia (CLI)	Tissue-engineered product	22/01/2016
Human adult allogenic mesodermal progenitor cells	Intended for the treatment of incomplete revascularisation as an adjunct to CABG in patients with congenital coronary artery malformations	Tissue-engineered product	29/01/2016
Scientific recommendation on classification of advanced therapy medicinal products: co-culture of keratinocytes and human amniotic membrane mesenchymal stem cells as seeded on acellular amniotic matrix	Intended for the treatment of burns, scars, non-healing wounds	Tissue-engineered product	29/01/2016
Scientific recommendation on classification of advanced therapy medicinal products: mesenchymal stem cells isolated from umbilical cord as a sheet	Intended for the treatment of burns, non-healing wounds	Tissue-engineered product	29/01/2016
Scientific recommendation on classification of advanced therapy medicinal products: mesenchymal stem cells isolated from umbilical cord suspended in autologous platelet rich plasma	Intended for the treatment of burns, non-healing wounds	Tissue-engineered product	29/01/2016
Scientific recommendation on classification of advanced therapy medicinal products: mesenchymal stem cells isolated from umbilical cord seeded acellular amniotic matrix	Intended for the treatment of burns, non-healing wounds	Tissue-engineered product	29/01/2016
Scientific recommendation on classification of advanced therapy medicinal products: mesenchymal stem cells isolated from umbilical cord seeded onto acellular dermal matrix	Intended for the treatment of burns, non-healing wounds	Tissue-engineered product	29/01/2016
Scientific recommendation on classification of advanced therapy medicinal products: co-culture of keratinocytes and mesenchymal stem cells isolated from umbilical cord seeded on acellular amniotic matrix	Intended for the treatment of burns and non-healing wounds	Tissue-engineered product	29/01/2016
Scientific recommendation on classification of advanced therapy medicinal products: co-culture of keratinocytes and mesenchymal stem cells isolated from umbilical cord seeded on acellular dermal matrix	Intended for the treatment of burns and non-healing wounds	Tissue engineered product	29/01/2016
Scientific recommendation on classification of advanced therapy medicinal products: co-culture of keratinocytes and human amniotic membrane mesenchymal stem cells as seeded on acellular dermal matrix	Intended for the treatment of burns, scars, non-healing wounds	Tissue-engineered product	29/01/2016
Scientific recommendation on classification of advanced therapy medicinal products: ex vivo expanded adipose-derived stem cell suspension	Autoimmune diseases (rheumatoid arthritis and systemic lupus erythematosus)	Somatic cell therapy medicinal product	26/01/2016
Scientific recommendation on classification of advanced therapy medicinal products: human amniotic membrane mesenchymal stem cells seeded on acellular dermal matrix	Intended for the treatment of burns, scars, non-healing wounds	Tissue-engineered product	29/01/2016
Scientific recommendation on classification of advanced therapy medicinal products: human amniotic membrane mesenchymal stem cells seeded on acellular amniotic matrix	Intended for the treatment of burns, scars, non-healing wounds	Tissue-engineered product	29/01/2016
Scientific recommendation on classification of advanced therapy medicinal products: human amniotic membrane mesenchymal stem cells in suspension	Intended for the treatment of burns, scars, non-healing wounds	Tissue-engineered product	29/01/2016
Scientific recommendation on classification of advanced therapy medicinal products: human amniotic membrane mesenchymal stem cells as a sheet	Intended for the treatment of burns, scars, non-healing wounds	Tissue-engineered product	29/01/2016
Scientific recommendation on classification of advanced therapy medicinal products: decellularized porcine dermal matrix	Intended for the treatment of various skin injuries	The product does not fall within the definition of an advanced therapy medicinal product	22/01/2016
Scientific recommendation on classification of advanced therapy medicinal products: co-culture of keratinocytes and mesenchymal stem cells isolated from umbilical cord seeded on transgenic porcine acellular dermal matri...	Intended for the treatment of deep and extensive burns, chronic wounds, skin donor sites	Tissue-engineered product - combined	22/01/2016
Scientific recommendation on classification of advanced therapy medicinal products: co-culture of keratinocytes and mesenchymal stem cells isolated from umbilical cord seeded on acellular amniotic matrix	Intended for the treatment of deep and extensive burns, chronic wounds, skin donor sites	Tissue-engineered product	22/01/2016
Scientific recommendation on classification of advanced therapy medicinal products: co-culture of keratinocytes and mesenchymal stem cells isolated from umbilical cord seeded on acellular dermal matrix	Intended for the treatment of deep and extensive burns, chronic wounds, skin donor sites	Tissue-engineered product	22/01/2016
Scientific recommendation on classification of advanced therapy medicinal products: Concentrate for solution for infusion	Intended for the treatment of ornithine transcarbamylase deficiency	Gene therapy medicinal product	21/12/2015
Scientific recommendation on classification of advanced therapy medicinal products: bone marrow-derived autologous non-hematopoietic stem cells	Intended for the treatment of type I diabetes	Somatic cell therapy medicinal product	21/12/2015
Scientific recommendation on classification of advanced therapy medicinal products: bone marrow-derived autologous non-hematopoietic stem cells	Intended for the treatment of type II diabetes	Somatic cell therapy medicinal product	21/12/2015
Scientific recommendation on classification of advanced therapy medicinal products: bone marrow-derived autologous non-hematopoietic stem cells	Intended for the treatment of patients after myocardial infarction	Tissue-engineered product	21/12/2015
Scientific recommendation on classification of advanced therapy medicinal products: bone marrow-derived autologous non-hematopoietic stem cells	Intended for the treatment of patients after ischemic stroke	Tissue-engineered product	21/12/2015
Scientific recommendation on classification of advanced therapy medicinal products: bone marrow-derived autologous non-hematopoietic stem cells	Intended for the treatment of rheumatoid arthritis	Somatic cell therapy medicinal product	21/12/2015
Scientific recommendation on classification of advanced therapy medicinal products: human hepatoblastoma cells (HepG2) encapsulated in alginate, expanded to competence and maintained in a fluidised bed bioreactor	Intended for the treatment of acute liver failure	Somatic cell therapy medicinal product - combined	21/12/2015
Scientific recommendation on classification of advanced therapy medicinal products: Pro-inflammatory dendritic cells	Intended for the treatment of metastatic renal cell carcinoma	Somatic cell therapy medicinal product	25/11/2015
Scientific recommendation on classification of advanced therapy medicinal products: Sterile suspension of autologous cells of stromal vascular fraction of adipose tissue in Lactated Ringers solution	Intended for the treatment of pain associated with joint osteoarthritis	Somatic cell therapy medicinal product	25/11/2015
Scientific recommendation on classification of advanced therapy medicinal products: Sterile suspension of autologous cells of stromal vascular fraction of adipose tissue in Lactated Ringers solution	Intended for the treatment of non-healing wounds and scarred tissue	Tissue-engineered product	25/11/2015
Scientific recommendation on classification of advanced therapy medicinal products: adipose derived regenerative cells encapsulated in hyaluronic acid	Treatment of articular cartilage and bone defects including osteoarthrosis or osteochondral lesions	Tissue-engineered medicinal product - combined	25/11/2015
Scientific recommendation on classification of advanced therapy medicinal products: Suspension of autologous expanded viable chondrocytes embedded in a cross linked hydrogel	Intended for the treatment of articular cartilage defect	Tissue-engineered product (combined)	28/10/2015
Scientific recommendation on classification of advanced therapy medicinal products: Vials containing allogeneic mesenchymal precursor cells	Intended for the treatment of chronic lumbar back pain	Tissue engineered product	28/10/2015
Scientific recommendation on classification of advanced therapy medicinal products: Hepatocyte-like cells are cryopreserved in the freezing solution, solution for injection	Intended for the treatment of inborn liver metabolic diseases like Crigler-Naijar syndrome 1 and for drug-induced acute liver failure such as paracetamol intoxication	Tissue-engineered product	28/10/2015
Scientific recommendation on classification of advanced therapy medicinal products: Autologous expanded mesenchymal cells seeded onto an allogeneic human decellularised trachea scaffold	Intended for the reconstruction of trachea subsequent to damage or stenosis due to cancer, injury, infection or congenital deformities	Tissue-engineered product	28/10/2015
Scientific recommendation on classification of advanced therapy medicinal products: allogeneic (human Wharton’s jelly derived) mesenchymal stem cells	Intended for the treatment of amyotrophic lateral sclerosis (ALS)	Somatic cell therapy product	27/10/2015
Scientific recommendation on classification of advanced therapy medicinal products: autologous adipose tissue derived mesenchymal stem cells	Intended for the treatment of amyotrophic lateral sclerosis (ALS)	Somatic cell therapy product	27/10/2015
Scientific recommendation on classification of advanced therapy medicinal products: autologous bone marrow derived mesenchymal stem cells	Intended for the treatment of amyotrophic lateral sclerosis (ALS)	Somatic cell therapy product	27/10/2015
Scientific recommendation on classification of advanced therapy medicinal products: cryopreserved allogeneic hematopoietic progenitor cells (HPC–CD34+) accompanied by facilitating cells (FC– CD8+/TCR-) and T cells, prepa...	Intendedfor the treatment of the prophylaxis of organ rejection via the establishment of donor-specific allogeneic tolerance allowing for the elimination of immunosuppressive therapy in adult patients receiving living donor kidney transplantation	Not an advanced therapy medicinal product	16/10/2015
Scientific recommendation on classification of advanced therapy medicinal products: The medicinal product consists of two compounds, both subcutaneously administered at the same implantation site: ”¢ Encapsulated alloge...	Intended for the treatment of malignant solid tumours	Gene therapy medicinal product (combined)	25/09/2015
Scientific recommendation on classification of advanced therapy medicinal products: Suspension of live-attenuated, double-deleted Listeria monocytogenes expressing human mesothelin for intravenous infusion	Treatment of malignant pleural mesothelioma	Gene therapy medicinal product	25/09/2015
Scientific recommendation on classification of advanced therapy medicinal products: autologous bone marrow mononuclear cells (BM-MNC)	To improve limb perfusion/restore blood flow to previously ischemic tissue, and improve the mobility and quality of life (QoL) of patients with peripheral artery disease and critical limb ischemia	Tissue-engineered product	24/07/2015
Scientific recommendation on classification of advanced therapy medicinal products: adeno-associated virus vector serotype rh10 encoding human factor IX	Treatment of haemophilia B	Gene therapy medicinal product	24/07/2015
Scientific recommendation on classification of advanced therapy medicinal products: Human monocytes-derived suppressive cells, expanded ex vivo	Treatment of acute Graft-versus-Host Disease refractory to first-line treatment	Somatic cell therapy medicinal product	17/07/2015
Scientific recommendation on classification of advanced therapy medicinal products: autologous engineered anti-CD19 Chimeric Antigen Receptor (CAR+) T-cells	Treatment of various types of cancer	Gene therapy medicinal product	17/07/2015
Scientific recommendation on classification of advanced therapy medicinal products: Irradiated plasmacytoid dendritic cell line loaded with peptides from tumour antigens	Treatment of metastatic cancer	Somatic cell therapy medicinal product	13/05/2015
Scientific recommendation on classification of advanced therapy medicinal products: autologous human gamma-delta T lymphocytes	Chronic Lymphocytic Leukaemia, Acute Lymphoblastic Leukaemia	Somatic cell therapy medicinal product	13/05/2015
Scientific recommendation on classification of advanced therapy medicinal products: autologous expanded viable chondrocytes combined with a three dimensional structure (biphasic collagen scaffold)	Articular cartilage defect of the knee	Tissue-engineered product (combined ATMP)	13/05/2015
Scientific recommendation on classification of advanced therapy medicinal products: allogeneic ex-vivo expanded placental mesenchymal-like adherent stromal cells	Treatment of Peripheral Arterial Occlusive Disease (PAOD)	Tissue-engineered product	17/04/2015
Scientific recommendation on classification of advanced therapy medicinal products: autologous mononuclear cells derived from human cord blood	Paediatric brain damage, hypoxic-ischaemic encephalopathy, and cerebral palsy	Tissue-engineered product	17/04/2015
Scientific recommendation on classification of advanced therapy medicinal products: Ex vivo expanded human umbilical tissue-derived cells	Improvement of visual acuity in patients with vision loss from geographic atrophy secondary to age-related macular degeneration	Somatic cell therapy medicinal product	17/04/2015
Scientific recommendation on classification of advanced therapy medicinal products: autologous dendritic cells loaded with autologous irradiated tumour stem cells	Treatment of melanoma	Somatic cell therapy medicinal product	17/04/2015
Scientific recommendation on classification of advanced therapy medicinal products: adult stem cell population, prepared from human skeletal muscle	Treatment of Duchenne Muscular Dystrophy (DMD)	Tissue engineered product	30/03/2015
Scientific recommendation on classification of advanced therapy medicinal products: Ex vivo expanded adult human bone-marrow derived pooled allogeneic mesenchymal stromal cells Scientific recommendation on classification of advanced therapy medicinal products: Ex vivo expanded adult human bone-marrow derived pooled allogeneic mesenchymal stromal cells	Thromboangiitis obliterans (Buerger's disease)	Somatic cell therapy medicinal product	27/02/2015
Scientific recommendation on classification of advanced therapy medicinal products: human extracellular matrix proteins (mainly Collagen I and glycosaminoglycans) and residual absorbable polymer, supplied as a lyophilize...	Surgical or interventional treatment of congenital heart defects, thereby correcting anatomic malformations	The product does not fall within the definition of an advanced therapy medicinal product	20/02/2015
Scientific recommendation on classification of advanced therapy medicinal products: Living, autologous, melanoma-derived lymphocytes (CD3+)	Therapeutic treatment of metastatic melanoma in patients pre-conditioned with chemotherapy and undergoing concomitant interleukin-2 (IL-2) treatment	Somatic cell therapy medicinal product	26/01/2015
Scientific recommendation on classification of advanced therapy medicinal products: Ex vivo expanded adipose-derived stem cells suspension	Autoimmune diseases (rheumatoid arthritis and systemic lupus erythematosus)	Somatic cell therapy medicinal product	26/01/2015
Scientific recommendation on classification of advanced therapy medicinal products: Cultured autologous chondrocytes	Intended for the treatment of focal non-arthritic cartilage defects of Outerbridge Classification Grade III or IV of the femoral condyle including the trochlea	Tissue-engineered product	17/12/2014
Scientific recommendation on classification of advanced therapy medicinal products: Allogeneic cord blood cells, ex vivo modulated with 16,16 dimethyl prostaglandin E2	Intended for the treatment of patients undergoing an haematopoietic stem cell transplantation	Tissue-engineered product	24/11/2014
Scientific recommendation on classification of advanced therapy medicinal products: In vitro derived platelets	Haematology	Not an advanced therapy medicinal product	24/11/2014
Scientific recommendation on classification of advanced therapy medicinal products: Autologous differentiated adipocytes derived from the subcutaneous adipose tissue	Intended for the treatment of primary perianal fistula	Tissue-engineered product	24/11/2014
Scientific recommendation on classification of advanced therapy medicinal products: Human mesenchymal stem cells derived from Wharton’s jelly tissue of umbilical cord (amyotrophic lateral sclerosis)	Intended for the treatment of Amyotrophic lateral sclerosis (ALS)	Somatic cell therapy medicinal product	14/11/2014
Scientific recommendation on classification of advanced therapy medicinal products: Human mesenchymal stem cells derived from Wharton’s jelly tissue of umbilical cord (graft-versus-host disease)	Intended for the treatment acute and chronic Graft-versus-Host Disease	Somatic cell therapy medicinal product	14/11/2014
Scientific recommendation on classification of advanced therapy medicinal products: Human mesenchymal stem cells derived from Wharton’s jelly tissue of umbilical cord (cartilage lesions)	Intended for the treatment of cartilage lesions	Tissue engineered product	14/11/2014
Scientific recommendation on classification of advanced therapy medicinal products: Human mesenchymal stem cells derived from Wharton’s jelly tissue of umbilical cord (cerebral palsy)	Intended for the treatment of cerebral palsy	Tissue engineered product	14/11/2014
Scientific recommendation on classification of advanced therapy medicinal products: AAV vector carrying an expression cassette for photoactivable enhanced halorhodopsin protein from Natronomonas pharaonis (eNpHR)	Intended for the treatment of Retinitis Pigmentosa	Gene therapy medicinal product	29/10/2014
Scientific recommendation on classification of advanced therapy medicinal products: Human retinal pigment epithelial cells derived from human embryotic stem cells	Intended for the treatment of age-related macular degeneration and Stargardt's macular dystrophy	Tissue-engineered product	29/10/2014
Scientific recommendation on classification of advanced therapy medicinal products: Medicinal product composed of living, genetically modified Lactococcus lactis bacteria, containing the gene for anti-human tumor necrosi...	Intended for the reduction of signs and symptoms, and induction and maintenance of clinical remission in patients with moderately active ulcerative colitis (UC)	Gene therapy medicinal product	17/10/2014
Scientific recommendation on classification of advanced therapy medicinal products: Killed spores of Bacillus subtilis incorporating a non-toxic antigen of Clostridium difficile	Intended for the prevention of Clostridium difficile infections in elderly patients	The product does not fall within the definition of an advanced therapy medicinal product.	19/09/2014
Scientific recommendation on classification of advanced therapy medicinal products: Adeno-Associated Viral Vectors derived from wild-type AAV2/5. The expression cassettes contain DNA encoding an RNA interference (RNAi) s...	Intended for the treatment of autosomal dominant rhodopsin-linked retinitis pigmentosa	Gene therapy medicinal product	25/07/2014
Scientific recommendation on classification of advanced therapy medicinal products: Autologous mature dendritic cells pulsed with tumour antigen-derived synthetic peptides	Intended for the treatment of glioblastoma	Somatic cell therapy medicinal product	25/07/2014
Scientific recommendation on classification of advanced therapy medicinal products: Allogeneic peripheral blood mononuclear cells induced to an early apoptotic state	Intended for the treatment of glioblastoma	Somatic cell therapy medicinal product	25/07/2014
Viral solution for injection of HSV-1 derived oncolytic virus	Intended for the treatment of advanced pancreatic cancer and / or unresectable hepatocellular carcinoma	Gene therapy medicinal product	02/07/2014
Scientific recommendation on classification of advanced therapy medicinal products: Plasmid encoding a mutation-inactivated E7-E6 fusion protein from Human Papillomavirus 16 linked to the human chemokine hMIP-1a via a di...	Intended for prevention and treatment of HPV16 induced pre-malignancies and malignancies	Gene therapy medicinal product	27/06/2014
Scientific recommendation on classification of advanced therapy medicinal products: Double-stranded naked DNA plasmid encoding an inactive human telomerase reverse transcriptase protein fused to ubiquitin	Intended for the treatment of various malignancies and the prevention of tumour relapse	Gene therapy medicinal product	27/06/2014
Scientific recommendation on classification of advanced therapy medicinal products: Autologous bone marrow aspirate enriched in autologous mesenchymal stromal cells	Intended for treatment in the field of regenerative medicine: bone damaged by disease (e.g. osteonecrosis), fracture or age-related loss of bone function	Tissue-engineered product	20/06/2014
Scientific recommendation on classification of advanced therapy medicinal products: Allogeneic engineered Chimeric Antigen Receptor (CAR+) T-cells	Intended for treatment of acute lymphoblastic leukemia and chronic lymphocytic leukemia	Gene-therapy medicinal product	28/05/2014
Scientific recommendation on classification of advanced therapy medicinal products: Autologous bone marrow cell aspirate in autologous plasma	Intended for treatment of osteoarthrosis and osteochondral lesion	Tissue-engineered product	28/05/2014
Scientific recommendation on classification of advanced therapy medicinal products: Tracheal scaffold seeded with autologous bone marrow derived mononuclear cells	Intended for reconstruction of trachea subsequent to damage or stenosis due to cancer, injury or infection	Tissue-engineered product - combined	28/05/2014
Autologous antigen-specific regulatory T lymphocytes suspended in a cryopreservation medium	Intended for the treatment of inflammatory eyes diseases and inflammatory articular diseases	Somatic cell therapy medicinal product	14/05/2014
Viable autologous adipose tissue-derived mesenchymal stem cells	Intended for the treatment of degenerative arthritis, osteoarthritis (OA), articular cartilage defects in the knee, ankle or hip joints	Tissue engineered product	14/05/2014
Scientific recommendation on classification of advanced therapy medicinal products: Autoulogous lymphoid effector cells specific against tumour-cells	Intended for treatment of solid tumours	Somatic cell-therapy medicinal product	24/02/2014
Scientific recommendation on classification of advanced therapy medicinal products: Viable, autologous keratinocytes and melanocytes grown on AS210 matrix. The active component of tissue engineered dermis consists of v...	Intended for wound healing	Tissue-engineered product	22/01/2014
Scientific recommendation on classification of advanced therapy medicinal products: Allogeneic activated leukocytes	Intended for treatment of chronic lower extremity ulcers in adult diabetic patients	Somatic cell-therapy medicinal product	21/01/2014
Scientific recommendation on classification of advanced therapy medicinal products: Ex-vivo expanded autologous skeletal myoblasts	Intended for treatment of oculopharyngeal muscular dystrophy	Tissue-engineered product	20/01/2014
Scientific recommendation on classification of advanced therapy medicinal products: Retinal pigment epithelium cells derived from human induced pluripotent stem cells	Intended for treatment of retinal degenerative diseases associated with dystrophic or dysfunctional retinal pigment epithelium cells	Tissue-engineered product	20/01/2014
Scientific recommendation on classification of advanced therapy medicinal products: Genetically modified adenovirus coding for human granulocyte-macrophage colony stimulating factor (GM-CSF)	Intended for treatment of cancer	Gene-therapy medicinal product	20/12/2013
Scientific recommendation on classification of advanced therapy medicinal products: Ex-vivo expanded autologous human corneal epithelium containing stem cells	Intended for treatment of limbal stem cell deficiency	Tissue-engineered product	05/12/2013
Scientific recommendation on classification of advanced therapy medicinal products: Autologous cell concentrate from bone marrow aspirate	Intended for treatment of avascular necrosis e.g. of the femur head	Not an advanced therapy medicinal product	19/07/2013
Scientific recommendation on classification of advanced therapy medicinal products: Human dermal fibroblasts cultured on bioresorbable polyglactin mesh	Intended for treatment of wounds and ulcers	Tissue engineered product	19/07/2013
Scientific recommendation on classification of advanced therapy medicinal products: Mesenchymal stem cells suspension extracted from bone (Ilium) marrow and cultivated during 18 days	Intended for treatment of chronic myocardial ischemia with left ventricular dysfunction	Tissue-engineered medicinal product	19/07/2013
Scientific recommendation on classification of advanced therapy medicinal products: Mesenchymal stem cells suspension extracted from Bone (Ilium) marrow and cultivated during 18 days and pretreated by melatonin during 24...	Intended for treatment of chronic myocardial ischemia with left ventricular dysfunction	Tissue-engineered medicinal product	19/07/2013
Scientific recommendation on classification of advanced therapy medicinal products: Sterile suspension on 5.10 viral particles in 0.5ml of A195 buffer	Intended for prevention and treatment of HCV and HCV-induced hepatocellular carcinoma	Not an advanced therapy medicinal product	19/07/2013
Scientific recommendation on classification of advanced therapy medicinal product: Adenoviral vector expressing the non-structural region of hepatitis C virus (HCV) in which a mutation has been introduced	Intended for treatment of glioma	Somatic cell therapy medicinal product	04/07/2013
Scientific recommendation on classification of advanced therapy medicinal products: Adipose derived mesenchymal stem cells combined with beta-tricalcium phosphate	Intended for treatment of bone defects.	Tissue-engineered medicinal product – combined.	21/06/2013
Scientific recommendation on classification of advanced-therapy medicinal product: Autologous expanded CD34+ stem cells	Intended for treatment of ccute myocardial infarction (AMI) via regeneration of damaged tissue	Tissue-engineered product	23/05/2013
Scientific recommendation on classification of advanced-therapy medicinal product: Human autologous tumour-infiltrating lymphocytes (TIL)	Intended for treatment of stage III melanoma with one invaded lymph node	Somatic cell therapy medicinal product	19/04/2013
Scientific recommendation on classification of advanced-therapy medicinal product: Pseudomonas aeruginosa bacteria genetically modified to secrete oncoproteins of Merkel-cell carcinoma	Intended for treatment of merkel cell carcinoma	Gene-therapy medicinal product	12/04/2013
Scientific recommendation on classification of advanced-therapy medicinal products: Allogeneic bone-marrow-derived mesenchymal cells	Intended for treatment of patients with acute graft-versus-host disease grades III and IV resistant to first line treatment	Somatic cell therapy medicinal product	12/04/2013
Scientific recommendation on classification of advanced-therapy medicinal products: Naturally-occurring allogeneic donor lymphocytes	Intended for treatment of therapy-refractory infectious and infection-related diseases and pre-emptive and prophylactic treatment of infectious and infection-related diseases	Somatic cell therapy medicinal product	12/04/2013
EBV-specific T cells in suspension in human albumin	Intended for the treatment of prophylactic or curative adoptive immunotherapy of EBV-associated malignant diseases	Somatic cell-therapy medicinal product	19/03/2013
Scientific recommendation on classification of advanced-therapy medicinal products: Alginate-encapsulated porcine pancreatic islet cells	Intended for treatment of type 1 diabetes mellitus	Somatic cell therapy medicinal product - combined	28/02/2013
Scientific recommendation on classification of advanced-therapy medicinal products: Adult autologous regenerative cells for subcutaneous administration	Intended for regeneration, repair, or replacement of weakened or injured subcutaneous tissue	Not an advanced therapy medicinal product	15/02/2013
Scientific recommendation on classification of advanced-therapy medicinal products: Adult autologous regenerative cells in autologous cell-enriched matrix for subcutaneous administration	Intended for regeneration, repair, or replacement of weakened or injured subcutaneous tissue	Not an advanced therapy medicinal product	15/02/2013
Scientific recommendation on classification of advanced therapy medicinal products: Allogeneic mesenchymal precursor cells (MPCs)	Intended for treatment of rheumatoid arthritis	Somatic cell therapy medicinal product	28/01/2013
Scientific recommendation on classification of advanced-therapy medicinal products: Tissue like combination of osteogenic cells and demineralised bone matrix (three-dimensional structure of demineralised bone matrix and ...	Intended for treatment of bone defects	Tissue engineered medicinal product	18/12/2012
Scientific recommendation on classification of advanced-therapy medicinal products: Concentrate of autologous bone marrow	Intended for increase new bone formation in critical area of atrophic non-union	Tissue engineered medicinal product, combined ATMP	18/12/2012
Scientific recommendation on classification of advanced-therapy medicinal products: Autologous mesenchymal stromal cells secreting neurotrophic factors	Intended for treatment of amyothropic lateral sclerosis	Somatic cell therapy medicinal product	18/12/2012
Scientific recommendation on classification of advanced-therapy medicinal products: Autologous skeletal muscle-derived-cells	Intended for repair of deficient external anal sphincter in patients suffering from faecal incontinence	Tissue-engineered product	28/11/2012
Scientific recommendation on classification of advanced-therapy medicinal products: Aqueous suspension of attenuated Salmonella typhi Ty21a strain transfected with a plasmid vector encoding for the human vascular endothe...	Intended for treatment of solid malignancies with or without metastases	Gene therapy medicinal product	28/11/2012
Scientific recommendation on classification of advanced-therapy medicinal products: Human ciliary neurotrophic factor (CNTF)	Intended for reducing photoreceptor loss associated with degeneration of the cells of the retina	Gene therapy medicinal product - combined	04/10/2012
Scientific recommendation on classification of advanced-therapy medicinal products: Recombinant herpes simplex virus type 1 (HSV-1) containing the gene encoding human granulocyte macrophage colony-stimulating factor (GM-...	Intended for treatment of adults with unresectable or metastatic melanoma	Gene therapy medicinal product	09/08/2012
Scientific recommendation on classification of advanced-therapy medicinal products: Bone-marrow-derived autologous suspensions of hematopoietic and mesenchymal stem cells depleted from erythrocytes and lymphocytes	Intended for treatment of complete or incomplete traumatic spinal cord injury	Tissue-engineered product	09/07/2012
Scientific recommendation on classification of advanced-therapy medicinal products: Allogenic and autologous haptenised and irradiated cells and corresponding cell lysates derived from the tumour mass of patients diagnos...	Intended for treatment of glioblastoma multiforme	Somatic cell therapy medicinal product	31/05/2012
Scientific recommendation on classification of advanced-therapy medicinal products: Autologous, non-manipulated lipoaspirate-containing adipocytes and stromal vascular fraction	No medical or therapeutic claims pursued. Autologous lipofiller	Not an advanced therapy medicinal product	31/05/2012
Scientific recommendation on classification of advanced-therapy medicinal products: Autologous cells of stromal vascular fraction of adipose tissue	Not medical or therapeutic claims pursued. Cosmetic lipofilling in combination with fresh lipoaspirate	Not an advanced therapy medicinal product	31/05/2012
Scientific recommendation on classification of advanced-therapy medicinal products: Autologous collagen derived from human adipose tissue	No medical or therapeutic claims pursued. Cosmetic dermal filling	Not an advanced therapy medicinal product	31/05/2012
Scientific recommendation on classification of advanced therapy medicinal products: Allogeneic human dermal fibroblasts	Intended for treatment of dermal scars, hypertrophic scars and contractures	Tissue-engineered product	31/05/2012
Scientific recommendation on classification of advanced therapy medicinal products: Autologous oral mucosa cells seeded onto a membrane	Intended for treatment of urethral stricture	Tissue engineered product - combined	22/03/2012
Scientific recommendation on classification of advanced-therapy medicinal products: Suspension of oncolytic adenovirus	Intended for treatment of colorectal cancer	Not an advanced therapy medicinal product	22/03/2012
Scientific recommendation on classification of advanced-therapy medicinal products: Bone-marrow-derived autologous CD34+ cells	Intended for improvement of heart function in patients with refractory angina and chronic myocardial ischemia	Tissue-engineered product	22/03/2012
Scientific recommendation on classification of advanced-therapy medicinal products: A mixture of autologous dendritic cells pulsed with a non-structural-3 protein fragment of the hepatitis-C virus and activated T-cells	Intended for treatment of patients with chronic HCV infection	Somatic cell therapy medicinal product	23/02/2012
Scientific recommendation on classification of advanced-therapy medicinal products: Autologous CD34+ haematopoietic stem cells (HSCs) transduced with lentiviral vector LentiGlobin encoding the human Î²A-T87Q-globin gene	Intended for treatment of beta-thalassemia major and intermedia, sickle cell anaemia	Gene therapy medicinal product	19/12/2011
Scientific recommendation on classification of advanced-therapy medicinal products: Autologous CD34+ haematopoietic stem cells transduced with lentiviral vector Lenti-D encoding the human ABCD1 gene	ntended for treatment of childhood cerebral adrenoleukodystrophy (CCALD)	Gene therapy medicinal product	19/12/2011
Scientific recommendation on classification of advanced therapy medicinal productss	Intended for autoimmune diseases with MHC restricted specific immunity e.g. multiple sclerosis, type I diabetes or graft rejection	Somatic cell therapy medicinal product	23/11/2011
Scientific recommendation on classification of advanced therapy medicinal products: Autologous bone marrow-derived CD133+ stem cells	Intended for improvement of heart function (LVEF) and quality of life in patients with ischemic heart disease post acute MI and in chronic ischaemic heart disease and after MI	Tissue-engineered product	07/11/2011
Scientific recommendation on classification of advanced therapy medicinal products: Concentrate of autologous bone marrow-derived mononuclear cells (BM-MNC)	Intended for improvement of heart function (LVEF) and quality of life in patients with ischaemic post acute MI and in chronic heart disease	Tissue-engineered product	07/11/2011
Scientific recommendation on classification of advanced therapy medicinal products: In vitro transcribed (IVT) ribonucleic acid (RNA)-electroporated and cultured autologous mature dendritic cells (DCs)	Intended for the treatment of advanced renal cell carcinoma	Somatic cell therapy medical product	14/10/2011
Scientific recommendation on classification of advanced therapy medicinal products: Autologous mesenchymal stem cells	Intended for treatment of chronic heart failure symptoms by improvement in exercise capacity of NYHA class II and III chronic heart failure patients receiving standard therapy	Tissue-engineered product - not combined	29/07/2011
Scientific recommendation on classification of advanced therapy medicinal products: Human islets of Langerhans	Intended for: Autologous: Post pancreatectomy for benign pancreatic pathologies Allogeneic: Treatment of severe forms of type 1 diabetes	Not an advanced therapy medicinal product	29/07/2011
Scientific recommendation on classification of advanced therapy medicinal products: Allogeneic bone-marrow derived osteoblastic cells	Intended for treatment of non-union, delayed union or other bone fractures	Tissue-engineered product - not combined	01/07/2011
Live recombinant lentiviral vectors encoding HIV epitopes to be used for therapeutic HIV vaccination of HIV-1 infected patients	Infectious disease: HIV-1	Not an advanced therapy medicinal product	27/05/2011
Heterologous human adult liver-derived progenitor cells	Intended for treatment of inborn errors of liver metabolism	Somatic cell therapy medicinal product - not combined	05/05/2011
Allogeneic human fibroblasts cultured onto a biodegradable matrix	Dermatology	Tissue engineered product - combined	04/04/2011
Medicinal product composed of living, genetically modified Lactococcus lactis bacteria, containing the human trefoil factor 1 (hTFF1) gene	Intended for prevention and treatment of chemotherapy-induced and/or radiotherapy-induced oral mucositis in patients with cancer of the head and the neck	Gene therapy medicinal product	08/02/2011
Layer of autologous corneal epithelium containing stem cells	Intended for treatment of extended corneal lesions	Tissue engineered product - not combined	20/12/2010
Lentiviral vector expressing the naturally occurring human anti-angiogenic proteins endostatin and angiostatin	Intended for treatment of age-related macular degeneration	Gene therapy medicinal product	30/11/2010
Allogeneic human aortic endothelial cells cultured in a porcine gelatin matrix	Intended for treatment of vascular injury	Somatic cell therapy medicinal product - not combined	04/10/2010
Non-integrative vector including a gene coding for an anti-HSV-1 meganuclease for the ex-vivo transduction of human cornea	Intended for prevention of infectious diseases in cornea grafted patients	Gene therapy medicinal product	04/10/2010
Adult skeletal muscle derived cells	Intended for treatment of female stress urinary incontinence	Tissue engineered product - not combined	04/10/2010
Allogeneic human placenta-derived, culture-expanded, mesenchymal-like cell population	Intended for treatment of chronic inflammatory diseases such as Crohn's disease, multiple sclerosis, rheumatoid arthritis and the treatment of ischaemic stroke	Somatic cell therapy product	04/10/2010
Autologous bone marrow-derived progenitor cells	Intended for treatment of patients with failed left ventricular recovery despite successful reperfusion therapy post acute myocardial infarction, chronic ischaemic heart disease, peripheral vascular diseases and Buerger's disease	Tissue engineered product	04/10/2010
Allogeneic mesenchymal precursor cells	Intended for treatment of cardiovascular disease	Tissue engineered product	05/08/2010
Umbilical cord blood cells expanded ex vivo using allogeneic mesenchymal precursor cells	Intended treatment of diseases in haematology-oncology therapeutic area	Tissue engineered product	05/08/2010
Frozen, cultured allogeneic keratinocytes on a silicone dressing material	Intended the treatment of acute burn wounds	Tissue engineered product - not combined	05/08/2010
Autologous human keratinocytes	Intended for treatment of superficial, partial and full thickness burns	Tissue engineered product - not combined	05/08/2010
Hollow fiber cartridges populated with the C3A cells to be used with ancillary support equipment	Intended for treatment of acute or chronic hepatitis	Somatic cell therapy medicinal product - combined	02/07/2010
Autologous ex-vivo pulsed dendritic cells	Intended for treatment of ovarian cancer	Somatic cell therapy medicinal product	02/07/2010
Mixture of porcine beta cell and their accompanying endocrine cell populations embedded in an alginate matrix	Endocrinology: intended for treatment of diabetes	Somatic cell therapy medicinal product - not combined	02/07/2010
DNA plasmid encoding for the human fibroblast growth factor type 1 (FGF 1)	Intended for treatment of critical limb ischaemia	Gene therapy medicinal product	12/05/ 2010
Allogeneic T cells encoding an exogenous TK gene	Intended as adjunct treatment in haematopoietic stem cell transplantation	Somatic cell therapy medicinal product	02/03/2010
Allogeneic human dermal fibroblasts	Intended for treatment of dystrophic epidermolysis bullosa	Tissue engineered product	02/03/2010
Lentiviral vector expressing the truncated form of human tyrosine hydroxylase (TH), human aromatic L-amino-acid decarboxylase (AADC), human GTP-cyclohydrolase 1 (CH1)	Intended for treatment of Parkinson's disease	Gene therapy medicinal product	02/03/2010
Genetically modified Lactococcus lactis secreting human interleukin-10	Intended for treatment of inflammatory bowel disease	Gene therapy medicinal product	12/02/2010
Autologous osteoprogenitor cells, isolated from bone marrow and expanded in vitro, incorporated, as an integral part, with 3D biodegradable scaffold	Intended for repairing and regenerating and replacing bone defects in odontostomatology and maxillofacial surgery	Tissue engineered product - combined	26/01/2010
Salmonella typhi strain genetically modified to secrete a fusion protein of the prostate specific antigen (PSA) and a protein leading to an increased antigenicity	Oncology: intended for treatment of prostate cancer	Gene therapy medicinal product	26/01/2010
Product consisting of naturally occurring antigen-specific CD8+ donor lymphocytes isolated with streptamers	Intended for treatment of infectious diseases	Not an advanced therapy medicinal product	26/01/2010
Buffy coat of centrifuged autologous bone marrow containing haematopoietic and mesenchymal stem cells.	Intended for treatment of incomplete and complete chronic traumatic spinal cord injury	Advanced therapy medicinal product	15/01/2010
Autologous cultured chondrocytes integrated in a scaffold	Intended for repair of symptomatic cartilage defects in joints such as the knee and ankle	Tissue engineered medicinal product - combined	15/01/2010
Adenovirus encoding vascular endothelial growth factor C (VEGF-C).	Intended for treatment of secondary lymphoedema associated with the treatment of breast cancer	Gene therapy medicinal product	15/01/2010
Autologous cell therapy product.	Intended for treatment of Crohn's disease	Somatic cell therapy medicinal product	15/01/2010
Allogeneic natural killer cells activated with a lysate from a cell line which is established from a patient with acute monoblastic leukaemia.	Intended for treatment of acute myeloid leukaemia	Somatic cell therapy medicinal product	15/01/2010
Allogeneic cultured corneal epithelial cell sheet in amniotic membrane scaffold	Intended for the treatment of ocular diseases	Tissue engineered product	15/01/2010
Mesenchymal stem cell-derived microvesicles (containing receptors, proteins, lipids, mRNA and microRNA).	Intended for treatment of renal diseases	Not an advanced therapy medicinal product	04/12/2009
Lentiviral vector expressing the human MYO7A gene.	Intended for the treatment of retinitis pigmentosa	Gene therapy medicinal product	04/12/2009
Lentiviral vector expressing the ABCA4 gene, packaged into infectious VS virus envelope.	Intended for the treatment of retinal disorders	Gene therapy medicinal product	04/12/2009
Adeno-associated virus (AAV) vector containing a gene coding for N-sulfoglucosamine sulfohydrolase	Intended for treatment of congenital, hereditary, and neonatal diseases and abnormalities	Gene therapy medicinal product	04/12/2009
Fresh and freeze - dried thrombocytes isolated from autologous or allogeneic blood	Intended for wound healing in orthopedic and dental surgery	Not an advanced therapy medicinal product	13/11/2009
Autologous tolerogenic dendritic cells derived from peripheral blood monocytes	Intended for treatment of rheumatoid arthritis	Somatic cell therapy medicinal product. Not combined	16/10/2009
A combination of lysates of tumour cells (autologous and allogenic) and living cells of a glioblastoma cell line	Oncology: intended for treatment of glioblastoma	Somatic cell therapy medicinal product	16/10/2009
Haploidentical donor T lymphocytes genetically modified to express HSV-Tk gene	Oncology: intended as adjunctive treatment post bone marrow transplantation in patients with high risk acute leukaemia	Somatic cell therapy medicinal product	16/10/2009
Suspension of expanded autologous skeletal muscle derived cells (myoblasts)	Urology/gynaecology: intended for regeneration of the external urethral sphincter muscle (rhabdosphincter) in patients suffering from various levels of stress urinary incontinence	Tissue engineered product - not combined	16/10/2009
Immunotherapeutic medicinal product composed of autologous tumour cells	Oncology: intended for treatment of colon cancer	Somatic cell therapy medicinal product.	13/08/2009
Advanced therapy medicinal product containing substantially modified cytotoxic T-cells of human origin	Oncology: intended for treatment of ovarian cancer	Somatic cell therapy medicinal product.	13/08/2009
Substantially modified human allogeneic fibroblasts and keratinocytes administered in conjunction with fibrin as structural component	Dermatology: intended for treatment of chronic venous leg ulcers	Somatic cell therapy medicinal product.	19/06/2009

Scientific recommendations on classification of advanced therapy medicinal products

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Scientific recommendations on classification of advanced therapy medicinal products

Archive of ATMP classifications (June 2009 to March 2019)

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