Scientific recommendations on classification of advanced therapy medicinal products
The European Medicines Agency's (EMA) Committee for Advanced Therapies (CAT) delivers scientific recommendations on whether a medicine can be classified as an advanced therapy medicinal product (ATMP).
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. |
-
List item
Scientific recommendations on classification of advanced therapy medicinal products (January 2021 - June 2023) (XLSX/149.29 KB)
First published: 25/05/2023
Last updated: 19/07/2023
EMA/140033/2021 -
List item
Scientific recommendations on classification of advanced therapy medicinal products (April 2019 - December 2020) (XLSX/107.73 KB)
First published: 10/11/2021
EMA/321214/2021
-
Product description Therapeutic area Classification Date of adoption of recommendation Intended for the treatment of X-linked retinitis pigmentosa
Gene therapy medicinal product 28/03/2019
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 DNA plasmid vector encoding human IL-12 Intended for the treatment of advanced melanoma Gene therapy medicinal product 28/03/2019 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 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 Allogeneic, ex vivo expanded, umbilical cord blood-derived, haematopoietic CD34+ progenitor cells, and allogeneic, non-expanded, umbilical cord blood-derived, haematopoietic mature myeloid and lymphoid cells Haematopoietic reconstitution of patients who are medically indicated for allogeneic haematopoietic stem cell transplantation Tissue engineered product 28/03/2019 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 Adeno-associated viral vector encoding the human cytochrome P450 21-hydroxylase gene
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 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 Cultured autologous adipose-derived stem cells on a scaffold Intended for urinary diversion in patients requiring radical cystectomy for the treatment of bladder cancer
Tissue engineered product (combined) 06/02/2019 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 Intended for the treatment of paediatric brain damage, hypoxic-ischemic encephalopathy, cerebral palsy Tissue engineered product 06/02/2019 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 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
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
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 Intended for the treatment of progressive hemifacial atrophy (Parry-Romberg syndrome)
Tissue engineered product 22/02/2019 Intended for the treatment of progressive hemifacial atrophy (Parry-Romberg syndrome)
Tissue engineered product 22/02/2019 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 Intended for the treatment of immune reconstitution in patients with congenital athymia
Tissue engineered product 20/12/2018
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
Intended for the treatment of multiple myeloma
Somatic cell therapy medicinal product 20/12/2018
DNA delivery vector carrying recombinant DNA encoding a RNA guided nuclease and guide RNAs targeting Shiga-toxin genes Intended for the treatment of infections mediated by Shiga-Toxin producing Escherichia coli Gene therapy medicinal product 20/12/2018
Intended for the treatment of Huntington’s disease Gene therapy medicinal product 19/11/2018 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 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 Intended for the treatment of epidermolysis bullosa
Tissue engineered product 19/11/2018 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 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 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 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 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
Intended for the treatment of retinitis pigmentosa
Gene therapy medicinal product 20/07/2018
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
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
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
Homogenate of antlerogenic stem cells
Intended for the therapeutic support in spinal cord injury
Tissue engineered product 20/07/2018
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
Codon-optimized human ornithine transcarbamylase messenger ribonucleic acid
Intended for the treatment of ornithine transcarbamylase deficiency
Gene therapy medicinal product 5/07/2018
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
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
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
Homogenate of antlerogenic stem cells
Intended for the treatment of recurrent corneal erosion syndrome
Tissue engineered product 5/07/2018
Cultured human olfactory ensheathing cells and olfactory nerve fibroblasts
Intended for the treatment of complete spinal cord injuries Tissue engineered product 22/06/2018 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 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
Autologous adipose cells
Intended for the treatment of anal fistula Tissue engineered product 26/04/2018 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 Human foetal neural stem cells
Intended for the treatment of amyotrophic lateral sclerosis Tissue engineered product 26/04/2018 Human foetal neural stem cells
Intended for the treatment of spinal cord injury Tissue engineered product 26/04/2018 Allogenic mesenchymal stem cells isolated from umbilical cord
Intended for the treatment of multiple sclerosis Tissue engineered product 28/03/2018 Autologous bone marrow-derived mesenchymal stem cells
Intended for the treatment of multiple sclerosis Tissue engineered product 28/03/2018 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 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 Ex vivo
used 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 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 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 Expanded autologous auricular chondrocytes
Intended for repair of microtia Tissue engineered product 22/02/2018 Autologous dendritic cells, pulsed with allogeneic tumour cell lysate
Intended for the treatment of malignant mesothelioma Somatic cell therapy medicinal product 29/01/2018 Allogeneic mesenchymal stem cells suspended in cell supernatant
Intended for the treatment of osteoarthritis Tissue engineered product 29/01/2018 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
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
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
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 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
Recombinant adeno-associated virus serotype 2/1 vector encoding human β
-hexosaminidase alpha and beta subunits
Intended for treatment of Tay-Sachs disease and Sandhoff disease
Gene therapy medicinal product 17/10/2017
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
Full-thickness human skin substitute composed of an epidermal layer of fully-stratified human keratinocytes and a collagen-rich dermal equivalent containing human dermal fibroblasts
Intended for treatment of patients with acute complex skin loss
Tissue engineered product 17/10/2017
Freshly isolated autologous CD34+
Intended for regeneration of soft and hard tissues of temporomandibular joints Tissue engineered product 17/10/2017 Autologous dental pulp stem cells
Intended for regeneration of soft and hard tissues of temporomandibular joints Tissue engineered product 17/10/2017 Intended for regeneration of soft and hard tissues of temporomandibular joints Tissue engineered product 17/10/2017
Intended for the treatment of amyotrophic lateral sclerosis
Tissue engineered medicinal product
14/09/2017
Allogeneic human glial-restricted precursors
Intended for the treatment of spinal cord injuries (four-limb paralysis, paresis) Tissue engineered medicinal product 14/09/2017 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 mRNAs encoding immunostimulatory proteins caTLR4, CD40L and CD70 and tumour associated antigens (TAA) tyrosinase, gp100, MAGE A3, MAGE C2 and PRAME
Intended for the treatment of melanoma
Gene therapy medicinal product 14/09/2017
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 Stromal vascular fraction cells
Indicated to relieve symptoms of osteoarthritis Somatic cell therapy medicinal product 30/06/2017 Human autologous keratinocytes
Intended for the treatment of burns and chronic, severe wounds
Tissue engineered medicinal product 30/06/2017 Human autologous chondrocytes
Intended for repair of single symptomatic cartilage defect of the knee or ankle
Tissue engineered product 30/06/2017 Human umbilical cord blood-derived mesenchymal stem cells
Intended for treatment of atopic dermatitis
Somatic cell therapy medicinal product 30/06/2017 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 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
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 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 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 Autologous adipose derived mesenchymal stem cells, freshly isolated
Intended for the treatment ofautoimmune drug resistant epilepsy Somatic cell therapy medicinal product 06/06/2017 Cultured allogenic Wharton's jelly derived mesenchymal stem cells
Intended for the treatment ofmyotrophic lateral sclerosis Tissue engineered product 06/06/2017 Cultured autologous adipose derived mesenchymal stem cells
Intended for the treatment ofautoimmune drug resistant epilepsy Somatic cell therapy medicinal product 06/06/2017 Cultured autologous adipose derived regenerative mesenchymal stem cells
Intended for the treatment ofautoimmune drug resistant epilepsy Somatic cell therapy medicinal product 06/06/2017 Cultured autologous Wharton's jelly derived mesenchymal stem cells
Intended for the treatment of amyotrophic lateral sclerosis Tissue engineered medicinal product 16/06/2017 Recombinant adeno-associated virus (AAV) pseudotyped with viral capsid from serotype 5 which holds a construct that contains two guide ribonucleic acids (gRNAs) sequences (CEP290-64 and CEP290-323) driven by human U6 promoter elements and the clustered regularly interspaced
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>G, in the CEP290 gene Gene therapy medicinal product 06/06/2017 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 Human autologous stromal vascular fraction (SVF)
Intended for the treatment of articular cartilage and bone defects Tissue engineered medicinal product 16/06/2017 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 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 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
Genetically modified oncolytic adenovirus coated with oligopeptide-end modified Poly (β-amino) esters
Intended for the treatment of pancreatic cancer Gene therapy medicinal product 29/03/2017 Intended for the treatment of advanced solid tumour malignancies that have failed available approved therapies
Gene therapy medicinal product 19/04/2017 Allogeneic human mesenchymal stem cells derived from umbilical cord
Intended for the treatment of intervertebral disc degeneration
Tissue engineered medicinal product 29/03/2017 Non-replicating rAAV8, expressing the human UGT1A1 gene
Intended for the treatment of Crigler-Najjar syndrome Gene therapy medicinal product 29/03/2017 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 Banked allogenic leukocytes
Intended for the treatment of metastatic Pancreatic Ductal Adeno Carcinoma
Somatic cell therapy medicinal product 29/03/2017 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 Autologous tumour-infiltrating lymphocytes
Intended for the treatment of metastatic melanoma Somatic cell therapy medicinal product 23/02/2017 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 In vitro
transcribed mRNA sequences encoding six non-small cell lung cancer associated antigens
Intended for the treatment of non-small cell lung cancer Gene therapy medicinal product 27/01/2017 mRNA sequence encoding the wild type human OX40L protein
Intended for the treatment of solid tumours
Gene therapy medicinal product 27/01/2017 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 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 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 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
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
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
Bone marrow-derived autologous non-haematopoietic stem cells
Intended for the treatment of multiple sclerosis Tissue engineered product 13/10/2016 Autologous anti-BCMA CAR-T cells
Intended for the treatment of multiple myeloma and B cell lymphoma Gene therapy medicinal product 13/10/2016 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 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 Autologous human adipose mesenchymal stromal cells, expanded in culture
Intended for cardiac repair Tissue engineered product 13/10/2016 Autologous skin cell suspension
Intended for burn wound treatment, donor site treatment Tissue engineered product 13/10/2016 A recombinant replicating vaccinia viral vector (
rilimogene galvacirepvec
) and a recombinant non-replicating fowlpox viral vector (
rilimogene glafolivec
), both expressing a modified human Prostate Specific Antigen (PSA) and three human costimulatory molecules (LFA-3, ICAM-1, and B7.1)
Intended for treatment of metastatic, castrate-resistant prostate cancer Gene therapy medicinal product 13/10/2016 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 Intended for treatment of metastatic melanoma and other solid tumours
Gene therapy medicinal product 16/09/2016 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 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 Recombinant adeno-associated viral vector serotype 8 (AAV8) encoding human glucose-6-phosphatase-α (G6Pase or G6PC)
Intended for the treatment of glycogen storage disease type Ia (von Gierke disease) Gene therapy medicinal product 19/07/2016 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 Heterologous human adult liver-derived progenitor cells
Intended for the treatment of fibro-inflammatory liver diseases Tissue-engineered product 19/07/2016 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
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 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 advaAllogenic 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
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 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 Live-attenuated, double-deleted Listeria monocytogenes expressing prostate antigens
Intended for the treatment of malignant prostate cancer
Gene therapy medicinal product 20/05/2016 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 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 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 In vitro cultured autologous chondrocytes
Intended for the treatment of cartilage loss in knee-joint Tissue engineered product 20/05/2016 Viable human autologous skin fibroblasts
Intended for filling of skin connective tissue loss (skin wounds)
Tissue engineered product 20/05/2016 Human autologous keratinocytes
Intended for the treatment of non-healing wounds, burns, trophic ulcers Tissue engineered product 20/05/2016 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 In vitro cultured autologous melanocytes
Intended for the treatment of vitiligo Tissue engineered product 20/05/2016 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 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 Autologous stromal vascular fraction
Autologous lipofilling
CAT cannot conclude on the classification of this product 04/04/2016 DNA plasmid encoding for the extracellular domain of human TNFα 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 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 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 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 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 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 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 Co-culture of keratinocytes and mesenchymal stem cells isolated from human burn eschar and debrided adipose tissue cells, seeded onto acellular dermal matrix
Intended for the treatment of deep and extensive burns, chronic wounds and skin donor sites Tissue-engineered product 03/03/2016 Co-culture of keratinocytes and mesenchymal stem cells isolated from human burn eschar and debrided adipose tissue cells, seeded onto acellular amniotic matrix
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 Co-culture of keratinocytes and human amniotic membranemesenchymal stem cells as seeded on acellular amniotic matrix
Intended for the treatment of burns, scars, non-healing wounds Tissue-engineered product 29/01/2016 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 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 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 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 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 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 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 Ex vivo expanded adipose-derived stem cell suspension in a pre-filled syringe for autologous application
Autoimmune diseases (rheumatoid arthritis and systemic lupus erythematosus) Somatic cell therapy medicinal product 26/01/2016 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 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 Human amniotic membrane mesenchymal stem cells in suspension
Intended for the treatment of burns, scars, non-healing wounds Tissue-engineered product 29/01/2016 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 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 Co-culture of keratinocytes and mesenchymal stem cells isolated from umbilical cord seeded on transgenic porcine acellular dermal matrix
Intended for the treatment of deep and extensive burns, chronic wounds, skin donor sites Tissue-engineered product - combined 22/01/2016 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 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 Adeno-associated virus serotype 8 vector encoding human ornithine transcarbamylase
Intended for the treatment of ornithine transcarbamylase deficiency Gene therapy medicinal product 21/12/2015 Bone marrow-derived autologous non-hematopoietic stem cells
Intended for the treatment of type I diabetes Somatic cell therapy medicinal product 21/12/2015 Bone marrow-derived autologous non-hematopoietic stem cells
Intended for the treatment of type II diabetes Somatic cell therapy medicinal product 21/12/2015 Bone marrow-derived autologous non-hematopoietic stem cells
Intended for the treatment of patients after myocardial infarction Tissue-engineered product 21/12/2015 Bone marrow-derived autologous non-hematopoietic stem cells
Intended for the treatment of patients after ischemic stroke
Tissue-engineered product 21/12/2015 Bone marrow-derived autologous non-hematopoietic stem cells
Intended for the treatment of rheumatoid arthritis
Somatic cell therapy medicinal product 21/12/2015 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 Pro-inflammatory dendritic cells
Intended for the treatment of metastatic renal cell carcinoma Somatic cell therapy medicinal product 25/11/2015 Autologous cells of stromal vascular fraction of adipose tissue
Intended for the treatment of pain associated with joint osteoarthritis Somatic cell therapy medicinal product 25/11/2015 Autologous cells of stromal vascular fraction of adipose tissue
Intended for the treatment of non-healing wounds and scarred tissue
Tissue-engineered product 25/11/2015 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 Autologous expanded viable chondrocytes in a cross-linked hydrogel
Intended for the treatment of articular cartilage defect Tissue-engineered product (combined) 28/10/2015 Allogeneic mesenchymal precursor cells
Intended for the treatment of chronic lumbar back pain Tissue engineered product
28/10/2015 Viable hepatocyte-like human embryonic stem cell-derived cells
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 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 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 Autologous adipose tissue derived mesenchymal stem cells
Intended for the treatment of amyotrophic lateral sclerosis (ALS) Somatic cell therapy product 27/10/2015 Autologous bone marrow derived mesenchymal stem cells
Intended for the treatment of amyotrophic lateral sclerosis (ALS) Somatic cell therapy product 27/10/2015 Cryopreserved allogeneic hematopoietic progenitor cells (HPC–CD34+) accompanied by facilitating cells (FC– CD8+/abTCR-) and ab T cells, prepared from mobilized peripheral blood mononuclear cells
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 Encapsulated allogeneic cells secreting GM-CSF and irradiated Autologous tumour cells
Intended for the treatment of malignant solid tumours
Gene therapy medicinal product (combined) 25/09/2015 Suspension of live-attenuated, double-deleted<i> Listeria monocytogenes</i> expressing human mesothelin
Treatment of malignant pleural mesothelioma
Gene therapy medicinal product 25/09/2015 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 Adeno-associated virus vector serotype rh10 encoding human factor IX
Treatment of haemophilia B
Gene therapy medicinal product 24/07/2015 Peripheral blood monocytes-derived suppressive cells
Treatment of acute Graft-versus-Host Disease refractory to first-line treatment Somatic cell therapy medicinal product 17/07/2015 Autologous engineered anti-CD19 Chimeric Antigen Receptor (CAR+) T-cells
Treatment of various types of cancer Gene therapy medicinal product 17/07/2015 Irradiated plasmacytoid dendritic cell line loaded with peptides from tumour antigens
Treatment of metastatic cancer Somatic cell therapy medicinal product 13/05/2015 Autologous human gamma-delta T lymphocytes
Chronic Lymphocytic Leukaemia, Acute Lymphoblastic Leukaemia Somatic cell therapy medicinal product 13/05/2015 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 Allogeneic ex-vivo expanded placental mesenchymal-like adherent stromal cells
Treatment of Peripheral Arterial Occlusive Disease (PAOD) Tissue-engineered product 17/04/2015 Autologous mononuclear cells derived from human cord blood
Paediatric brain damage, hypoxic-ischaemic encephalopathy, and cerebral palsy Tissue-engineered product 17/04/2015 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 Autologous dendritic cells loaded with autologous irradiated tumour stem cells
Treatment of melanoma Somatic cell therapy medicinal product 17/04/2015 Adult stem cell population, prepared from human skeletal muscle
Treatment of Duchenne Muscular Dystrophy (DMD) Tissue engineered product 30/03/2015 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 Human extracellular matrix proteins (mainly Collagen I and glycosaminoglycans) and residual absorbable polymer, supplied as a lyophilized (dry) and ethylene-oxide sterilised product
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 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 Ex vivo expanded adipose-derived stem cells suspension
Autoimmune diseases (rheumatoid arthritis and systemic lupus erythematosus) Somatic cell therapy medicinal product 26/01/2015 Cultured autologous chondrocytes in fibrin based excipient of human origin
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 Allogeneic cord blood cells, 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 In vitro derived platelets
Haematology Not an advanced therapy medicinal product 24/11/2014 Autologous differentiated adipocytes derived from the subcutaneous adipose tissue
Intended for the treatment of primary perianal fistula Tissue-engineered product 24/11/2014 Allogeneic, human Wharton's jelly derived mesenchymal stem cells
Intended for the treatment of Amyotrophic lateral sclerosis (ALS) Somatic cell therapy medicinal product 14/11/2014 Allogeneic, human Wharton's jelly derived mesenchymal stem cells
Intended for the treatment acute and chronic Graft-versus-Host Disease Somatic cell therapy medicinal product 14/11/2014 Allogeneic, human Wharton's jelly derived mesenchymal stem cells
Intended for the treatment of cartilage lesions Tissue engineered product 14/11/2014 Allogeneic, human Wharton's jelly derived mesenchymal stem cells
Intended for the treatment of cerebral palsy Tissue engineered product 14/11/2014 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 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 Medicinal product composed of living, genetically modified Lactococcus lactis bacteria, containing the gene for anti-human tumor necrosis factor-alpha protein
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 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 Adeno-Associated Viral Vectors derived from wild-type AAV2/5. The expression cassettes contain DNA encoding an RNA interference (RNAi) suppressor molecule, designed to suppress both mutant and wild-type rhodopsin gene transcripts
Intended for the treatment of autosomal dominant rhodopsin-linked retinitis pigmentosa Gene therapy medicinal product 25/07/2014 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 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 Plasmid encoding a mutation-inactivated E7-E6 fusion protein from Human Papillomavirus 16 linked to the human chemokine hMIP-1a via a dimerization module derived from human IgG3
Intended for prevention and treatment of HPV16 induced pre-malignancies and malignancies Gene therapy medicinal product 27/06/2014 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 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 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 Autologous bone marrow cell aspirate in autologous plasma
Intended for treatment of osteoarthrosis and osteochondral lesion Tissue-engineered product 28/05/2014 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 Autologous lymphoid effector cells specific against tumour-cells
Intended for treatment of solid tumours Somatic cell-therapy medicinal product 24/02/2014 Viable, autologous keratinocytes and melanocytes grown on AS210 matrix. The active component of tissue engineered dermis consists of viable, autologous fibroblasts
Intended for wound healing Tissue-engineered product 22/01/2014 Allogeneic activated leukocytes
Intended for treatment of chronic lower extremity ulcers in adult diabetic patients Somatic cell-therapy medicinal product 21/01/2014 Ex-vivo expanded autologous skeletal myoblasts
Intended for treatment of oculopharyngeal muscular dystrophy Tissue-engineered product 20/01/2014 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 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 Ex-vivo expanded autologous human corneal epithelium containing stem cells
Intended for treatment of limbal stem cell deficiency Tissue-engineered product 05/12/2013 Concentrate of autologous, uncultured, custom-prepared bone marrow aspirate
Intended for treatment of avascular necrosis e.g. of the femur head Not an advanced therapy medicinal product 19/07/2013 Human dermal fibroblasts cultured on bioresorbable polyglactin mesh
Intended for treatment of wounds and ulcers Tissue engineered product 19/07/2013 Cultured mesenchymal stem cells suspension extracted from bone (Ilium) marrow
Intended for treatment of chronic myocardial ischemia with left ventricular dysfunction Tissue-engineered medicinal product 19/07/2013 Mesenchymal stem cells extraction from bone (Ilium) marrow, cultured and preheated by melatonin
Intended for treatment of chronic myocardial ischemia with left ventricular dysfunction Tissue-engineered medicinal product 19/07/2013 Adenoviral vector expressing the non-structural region of hepatitis C virus (HCV) in which a mutation has been introduced
Intended for prevention and treatment of HCV and HCV-induced hepatocellular carcinoma Not an advanced therapy medicinal product 19/07/2013 Autologous dendritic cells activated with autologous oncolysate
Intended for treatment of glioma Somatic cell therapy medicinal product 04/07/2013 Adipose derived mesenchymal stem cells combined with beta-tricalcium phosphate
Intended for treatment of bone defects. Tissue-engineered medicinal product – combined. 21/06/2013 Autologous expanded CD34+ stem cells
Intended for treatment of ccute myocardial infarction (AMI) via regeneration of damaged tissue Tissue-engineered product 23/05/2013 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 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 Allogeneic bone marrow derived mesenchymal cells (MSCs) expanded ex vivo in synthetic media
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 Naturally-occurring allogeneic donor lymphocytes (derived from a leukapheresis, bone marrow or a whole blood product) that are enriched for antigen-specific CD4+ and CD8+ T cells using the Cytokine Capture system (IFN-gamma)
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 Alginate encapsulated porcine pancreatic islet cells
Intended for treatment of type 1 diabetes mellitus Somatic cell therapy medicinal product - combined 28/02/2013 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 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 Allogeneic Mesenchymal Precursor Cells (MPCs)
Intended for treatment of rheumatoid arthritis Somatic cell therapy medicinal product 28/01/2013 Tissue like combination of osteogenic cells and demineralised bone matrix (Three-dimensional structure of demineralised bone matrix and autologous adipose-derived and differentiated osteogenic cells)
Intended for treatment of bone defects Tissue engineered medicinal product 18/12/2012 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 Autologous mesenchymal stromal cells secreting NeuroTrophic factors
Intended for treatment of amyothropic lateral sclerosis Somatic cell therapy medicinal product 18/12/2012 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 Aqueous suspension of attenuated Salmonella typhi Ty21a strain transfected with a plasmid vector encoding for the human vascular endothelial growth factor receptor 2
Intended for treatment of solid malignancies with or without metastases Gene therapy medicinal product 28/11/2012 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 Recombinant Herpes Simplex Virus type 1 (HSV-1) containing the gene encoding human granulocyte macrophage colony-stimulating factor (GM-CSF)
Intended for treatment of adults with unresectable or metastatic melanoma Gene therapy medicinal product 09/08/2012 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 Allogenic and autologous haptenised and irradiated cells and corresponding cell lysates derived from the tumour mass of patients diagnosed with glioblastoma multiforme
Intended for treatment of glioblastoma multiforme Somatic cell therapy medicinal product 31/05/2012 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 Autologous cells of stromal vascular fraction (SVF) 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 Autologous collagen (AC) derived from human adipose tissue
No medical or therapeutic claims pursued. Cosmetic dermal filling Not an advanced therapy medicinal product 31/05/2012 Allogeneic human dermal fibroblasts
Intended for treatment of dermal scars, hypertrophic scars and contractures
Tissue-engineered product 31/05/2012 Autologous oral mucosa cells seeded onto a membrane
Intended for treatment of urethral stricture Tissue engineered product - combined 22/03/2012 Suspension of oncolytic adenovirus
Intended for treatment of colorectal cancer Not an advanced therapy medicinal product 22/03/2012 Intended for improvement of heart function in patients with refractory angina and chronic myocardial ischemia Tissue-engineered product 22/03/2012 A mixture of autologous dendritc cells (DCs) pulsed with a Non structural 3 (NS3) protein fragment of Hepatitis C Virus (HCV) and activated T-cells
Intended for treatment of patients with chronic HCV infection Somatic cell therapy medicinal product 23/02/2012 Autologous CD34+ haematopoietic stem cells (HSCs) transduced with the lentiviral vector LentiGlobin encoding the human βA-T87Q-globin gene
Intended for treatment of beta-thalassemia major and intermedia, sickle cell anaemia
Gene therapy medicinal product 19/12/2011 Autologous CD34+ haematopoietic stem cells (HSCs) transduced with lentiviral vector Lenti-D encoding the human ABCD1 cDNA
ntended for treatment of childhood cerebral adrenoleukodystrophy (CCALD)
Gene therapy medicinal product 19/12/2011 Autologous CD4+ T cells targeted to cells presenting class II restricted epitope s
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 CD133+ stem cells derided autologous bone marrow
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 Concentrate of autologous bone marrow 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 Autologous dendritic cell (DC) immunotherapy consisting of autologous mature DCs co-electroporated with autologous RCC IVT RNA and synthetic CD40L IVT RNA
Intended for the treatment of advanced renal cell carcinoma Somatic cell therapy medical product 14/10/2011 Autologous mesenchymal stem cells (MSC)
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 Human islets of Langerhans
Intended for:
Autologous: Post pancreatectomy for benign pancreatic pathologies
Allogeneic: Treatment of severe forms of type 1 diabetesNot an advanced therapy medicinal product 29/07/2011 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