Summaries of scientific recommendations on classification of advanced therapy medicinal products

The European Medicines Agency's Committee for Advanced Therapies (CAT) delivers scientific recommendations on whether a medicine can be classified as an advanced therapy medicinal product (ATMP). The Agency publishes the outcomes of these assessments in the format of summary reports.

Summary reports are available for classification recommendations from July 2011 (ordered by date of adoption of recommendation).

For more information, see

Product description Therapeutic area Classification Date of adoption of recommendation
PDF iconOrgan 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

PDF iconRecombinant 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

PDF iconStromal 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

PDF iconNon-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

PDF iconAutologous 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

PDF iconFour in vitro transcribed mRNA molecules each encoding one tumour antigen Intended for the treatment of malignant melanoma Gene therapy medicinal product

20/07/2018

PDF iconIn 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

PDF iconHomogenate of antlerogenic stem cells

Intended for the therapeutic support in spinal cord injury

Tissue engineered product

20/07/2018

PDF iconRecombinant 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

PDF iconCodon-optimized human ornithine transcarbamylase messenger ribonucleic acid

Intended for the treatment of ornithine transcarbamylase deficiency

Gene therapy medicinal product

5/07/2018

PDF iconDystrophin 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

PDF iconDystrophin 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

PDF iconAutologous 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

PDF iconHomogenate of antlerogenic stem cells

Intended for the treatment of recurrent corneal erosion syndrome

Tissue engineered product

5/07/2018

PDF iconCultured human olfactory ensheathing cells and olfactory nerve fibroblasts Intended for the treatment of complete spinal cord injuries Tissue engineered product 22/06/2018
PDF iconAutologous 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
PDF iconAdeno-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

PDF iconAutologous adipose cells Intended for the treatment of anal fistula Tissue engineered product 26/04/2018
PDF iconExosomes 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
PDF iconHuman foetal neural stem cells Intended for the treatment of amyotrophic lateral sclerosis Tissue engineered product 26/04/2018
PDF iconHuman foetal neural stem cells Intended for the treatment of spinal cord injury Tissue engineered product 26/04/2018
PDF iconAllogenic mesenchymal stem cells isolated from umbilical cord Intended for the treatment of multiple sclerosis Tissue engineered product 28/03/2018
PDF iconAutologous bone marrow-derived mesenchymal stem cells Intended for the treatment of multiple sclerosis Tissue engineered product 28/03/2018
PDF iconAllogeneic 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
PDF iconAutologous bone marrow-derived human mesenchymal stem cells Intended for the treatment of articular cartilage damage and tendon injuries Tissue engineered product 28/03/2018
PDF iconEx vivo PDF icon 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
PDF iconAllogeneic 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
PDF iconAutologous enriched CD31+ cell fraction from peripheral blood Intended for the surgical care of bone fractures Not an advanced therapy medicinal product 28/03/2018
PDF iconExpanded autologous auricular chondrocytes Intended for repair of microtia Tissue engineered product 22/02/2018
PDF iconAutologous dendritic cells, pulsed with allogeneic tumour cell lysate Intended for the treatment of malignant mesothelioma Somatic cell therapy medicinal product 29/01/2018
PDF iconAllogeneic mesenchymal stem cells suspended in cell supernatant Intended for the treatment of osteoarthritis Tissue engineered product 29/01/2018
PDF iconAutologous 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

PDF iconAutologous 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

PDF iconCD1c (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

PDF iconCultured 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
PDF iconAllogenic adipose-derived stem cells differentiated PDF iconin vitro PDF icon towards the cardiovascular lineage

Intended to restore cardiac function post myocardic infarction

Tissue engineered product (combined)

17/10/2017

PDF iconRecombinant adeno-associated virus serotype 2/1 vector encoding human β PDF icon-hexosaminidase alpha and beta subunits

Intended for treatment of Tay-Sachs disease and Sandhoff disease

Gene therapy medicinal product

17/10/2017

PDF iconAdeno-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

PDF iconFull-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

PDF iconFreshly isolated autologous CD34+ Intended for regeneration of soft and hard tissues of temporomandibular joints Tissue engineered product 17/10/2017
PDF iconAutologous dental pulp stem cells Intended for regeneration of soft and hard tissues of temporomandibular joints Tissue engineered product 17/10/2017

PDF iconCultured dental pulp stem cells

Intended for regeneration of soft and hard tissues of temporomandibular joints Tissue engineered product

17/10/2017

PDF iconAllogeneic human glial-restricted precursors

Intended for the treatment of amyotrophic lateral sclerosis

Tissue engineered medicinal product

14/09/2017

PDF iconAllogeneic human glial-restricted precursors Intended for the treatment of spinal cord injuries (four-limb paralysis, paresis) Tissue engineered medicinal product 14/09/2017
PDF iconNuclease resistant, synthetic double-stranded small interfering RNA (siRNA) Intended for the treatment of hepatic fibrosis Not an advanced therapy medicinal product 14/09/2017
PDF iconmRNAs 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

PDF iconViable chondrocytes cultured within a 3D hydrogel Intended for the treatment of articular cartilage defects of the knee Tissue engineered product (combined) 14/09/2017
PDF iconStromal vascular fraction cells Indicated to relieve symptoms of osteoarthritis Somatic cell therapy medicinal product 30/06/2017
PDF iconHuman autologous keratinocytes

Intended for the treatment of burns and chronic, severe wounds

Tissue engineered medicinal product 30/06/2017
PDF iconHuman autologous chondrocytes

Intended for repair of single symptomatic cartilage defect of the knee or ankle

Tissue engineered product 30/06/2017
PDF iconHuman umbilical cord blood-derived mesenchymal stem cells

Intended for treatment of atopic dermatitis

Somatic cell therapy medicinal product 30/06/2017
PDF iconAutologous 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
PDF iconAllogeneic haptenized, stimulated and irradiated non-proliferative colorectal tumour whole cells derived from 3 colorectal cell lines PDF icon

Intended for the treatment of colorectal cancer

Somatic cell therapy medicinal product

12/05/2017

PDF iconAutologous 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
PDF iconReplication 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
PDF iconAllogeneic 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
PDF iconAutologous adipose derived mesenchymal stem cells, freshly isolated Intended for the treatment ofautoimmune drug resistant epilepsy Somatic cell therapy medicinal product 06/06/2017
PDF iconCultured allogenic Wharton's jelly derived mesenchymal stem cells Intended for the treatment ofmyotrophic lateral sclerosis Tissue engineered product 06/06/2017
PDF iconCultured autologous adipose derived mesenchymal stem cells Intended for the treatment ofautoimmune drug resistant epilepsy Somatic cell therapy medicinal product 06/06/2017
PDF iconCultured autologous adipose derived regenerative mesenchymal stem cells Intended for the treatment ofautoimmune drug resistant epilepsy Somatic cell therapy medicinal product 06/06/2017
PDF iconCultured autologous Wharton's jelly derived mesenchymal stem cells Intended for the treatment of amyotrophic lateral sclerosis Tissue engineered medicinal product 16/06/2017
PDF iconRecombinant 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&gtG, in the CEP290 gene Gene therapy medicinal product 06/06/2017
PDF iconAllogeneic 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
PDF iconHuman autologous stromal vascular fraction (SVF) Intended for the treatment of articular cartilage and bone defects Tissue engineered medicinal product 16/06/2017
PDF iconHuman autologous adipose-derived stromal/stem cells (ADSCs) Intended for the treatment of articular cartilage and bone defects Tissue engineered medicinal product 16/06/2017
PDF iconHuman 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
PDF iconResorbable, 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

PDF iconNatural killer cells derived from human induced pluripotent stem cells transduced to express high-affinity non-cleavable CD16 (hnCD16) Fc receptor

Intended for the treatment of advanced solid tumour malignancies that have failed available approved therapies

Gene therapy medicinal product 19/04/2017
PDF iconAllogeneic human mesenchymal stem cells derived from umbilical cord

Intended for the treatment of intervertebral disc degeneration

Tissue engineered medicinal product 29/03/2017
PDF iconNon-replicating rAAV8, expressing the human UGT1A1 gene Intended for the treatment of Crigler-Najjar syndrome Gene therapy medicinal product 29/03/2017
PDF iconAutologous bone marrow derived mesenchymal stem cells Intended for the treatment of coma (traumatic brain injury, stroke) Somatic cell therapy medicinal product 29/03/2017
PDF iconBanked allogenic leukocytes

Intended for the treatment of metastatic Pancreatic Ductal Adeno Carcinoma

Somatic cell therapy medicinal product 29/03/2017
PDF iconViable 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
PDF iconAutologous tumour-infiltrating lymphocytes Intended for the treatment of metastatic melanoma Somatic cell therapy medicinal product 23/02/2017
PDF iconGenetically 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
PDF iconIn vitro PDF icon 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
PDF iconmRNA sequence encoding the wild type human OX40L protein

Intended for the treatment of solid tumours

Gene therapy medicinal product 27/01/2017

PDF iconAllogeneic 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
PDF iconAllogeneic 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
PDF iconAllogeneic 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
PDF iconAutologous 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

PDF iconBone marrow derived lineage negative heterogenic stem and progenitor cells Intended for treatment of amyotrophic lateral sclerosis in adults Tissue engineered product

19/12/2016

PDF iconAllogeneic 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

PDF iconBone marrow-derived autologous non-haematopoietic stem cells Intended for the treatment of multiple sclerosis Tissue engineered product 13/10/2016
PDF iconAutologous anti-BCMA CAR-T cells Intended for the treatment of multiple myeloma and B cell lymphoma Gene therapy medicinal product 13/10/2016
PDF iconWharton jelly derived allogeneic mesenchymal stem cells, cultured PDF iconin vitro Intended for the treatment of acute myocardial infarction, chronic ischaemic heart failure, no-option critical limb ischaemia Tissue engineered product 13/10/2016
PDF iconRecombinant modified PDF icon vaccinia virus ankara PDF icon (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
PDF iconAutologous human adipose mesenchymal stromal cells, expanded in culture Intended for cardiac repair Tissue engineered product 13/10/2016
PDF iconAutologous skin cell suspension Intended for burn wound treatment, donor site treatment Tissue engineered product 13/10/2016
PDF iconA recombinant replicating vaccinia viral vector ( PDF iconrilimogene galvacirepvec PDF icon) and a recombinant non-replicating fowlpox viral vector ( PDF iconrilimogene glafolivec PDF icon), 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

PDF iconLiving, genetically modified <i>Lactobacillus reuteri</i> 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
PDF iconHuman 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 (TNFα) and interleukin 2 (IL2)

Intended for treatment of metastatic melanoma and other solid tumours

Gene therapy medicinal product 16/09/2016

PDF iconAutologous T-cells expressing a chimeric NKG2D receptor

Intended for treatment of various tumour types

Gene therapy medicinal product 16/09/2016
PDF iconThe 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
PDF icon<i>Ex-vivo</i> 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
PDF iconRecombinant 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
PDF iconHeterologous human adult liver-derived progenitor cells Intended for the treatment of fibro-inflammatory liver diseases Tissue-engineered product 19/07/2016
PDF iconAutologous 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

PDF iconFour 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
PDF icon Autologous concentrated bone marrow Intended for the treatment of critical limb ischemia without surgical option Tissue engineered product 01/07/2016
PDF icon 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
PDF iconLive attenuated Listeria monocytogenes transfected with plasmids encoding HPV fusion protein

Intended for the treatment of cervical cancer

Gene therapy medicinal product

01/07/2016

PDF iconHaematopoietic stem cells genetically modified to express a zinc finger nuclease which disrupts the enhancer of BCL11A expression Intended for the treatment of ß-thalassaemia Gene therapy medicinal product 21/04/2016

PDF iconAutologous 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
PDF iconAutologous 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
PDF iconAutologous <i>ex vivo </i>expanded polyclonal CD4<sup>+</sup>CD25<sup>+</sup>CD127<sup>lo/-</sup>FOXP3<sup>+</sup> regulatory T cells

Intended for the treatment of type 1 Diabetes Mellitus

Somatic cell therapy medicinal product 04/04/2016
PDF iconViable autologous adipose-derived regenerative cells Autologous dermal filling CAT cannot conclude on the classification of this product 04/04/2016
PDF iconHuman 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
PDF iconHuman burn eschar and debrided adipose tissue cells (suspension) Intended for the treatment of burns, scars, non-healing wounds Tissue engineered product 23/03/2016
PDF iconHuman burn eschar and debrided adipose tissue cells (sheet) Intended for the treatment of burns, scars, non-healing wounds Tissue engineered product 23/03/2016
PDF iconHuman 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
PDF iconHuman 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
PDF iconAdenovirus 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
PDF iconCo-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
PDF iconTwo 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
PDF icon<i>Ex vivo</i> 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
PDF iconAdeno-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
PDF iconAutologous blood-derived cells filtered to remove other blood components Intended for the treatment of critical limb ischemia (CLI) Tissue-engineered product 22/01/2016
PDF iconHuman 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
PDF iconCo-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
PDF iconMesenchymal stem cells isolated from umbilical cord as a sheet Intended for the treatment of burns, non-healing wounds Tissue-engineered product 29/01/2016
PDF iconMesenchymal 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
PDF iconMesenchymal 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
PDF iconMesenchymal 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
PDF iconCo-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
PDF iconCo-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
PDF iconCo-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
PDF icon<i>Ex vivo</i> 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
PDF iconHuman 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
PDF iconHuman 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
PDF iconHuman amniotic membrane mesenchymal stem cells in suspension Intended for the treatment of burns, scars, non-healing wounds Tissue-engineered product 29/01/2016
PDF iconHuman amniotic membrane mesenchymal stem cells as a sheet Intended for the treatment of burns, scars, non-healing wounds Tissue-engineered product 29/01/2016
PDF iconDecellularized 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
PDF iconCo-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
PDF iconCo-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
PDF iconCo-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
PDF iconAdeno-associated virus serotype 8 vector encoding human ornithine transcarbamylase Intended for the treatment of ornithine transcarbamylase deficiency Gene therapy medicinal product 21/12/2015
PDF iconBone marrow-derived autologous non-hematopoietic stem cells Intended for the treatment of type I diabetes Somatic cell therapy medicinal product 21/12/2015
PDF iconBone marrow-derived autologous non-hematopoietic stem cells Intended for the treatment of type II diabetes Somatic cell therapy medicinal product 21/12/2015
PDF iconBone marrow-derived autologous non-hematopoietic stem cells Intended for the treatment of patients after myocardial infarction Tissue-engineered product 21/12/2015
PDF iconBone marrow-derived autologous non-hematopoietic stem cells

Intended for the treatment of patients after ischemic stroke

Tissue-engineered product 21/12/2015
PDF iconBone marrow-derived autologous non-hematopoietic stem cells

Intended for the treatment of rheumatoid arthritis

Somatic cell therapy medicinal product 21/12/2015
PDF iconHuman 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
PDF iconPro-inflammatory dendritic cells Intended for the treatment of metastatic renal cell carcinoma Somatic cell therapy medicinal product 25/11/2015
PDF iconAutologous 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
PDF iconAutologous 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
PDF iconAdipose 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
PDF iconAutologous expanded viable chondrocytes in a cross-linked hydrogel Intended for the treatment of articular cartilage defect Tissue-engineered product (combined) 28/10/2015
PDF iconAllogeneic mesenchymal precursor cells Intended for the treatment of chronic lumbar back pain

Tissue engineered product

28/10/2015
PDF iconViable 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
PDF iconAutologous 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
PDF iconAllogeneic (human Wharton's jelly derived) mesenchymal stem cells Intended for the treatment of amyotrophic lateral sclerosis (ALS) Somatic cell therapy product 27/10/2015
PDF iconAutologous adipose tissue derived mesenchymal stem cells Intended for the treatment of amyotrophic lateral sclerosis (ALS) Somatic cell therapy product 27/10/2015
PDF iconAutologous 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
PDF iconEncapsulated 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
PDF iconSuspension of live-attenuated, double-deleted<i> Listeria monocytogenes</i> expressing human mesothelin

Treatment of malignant pleural mesothelioma

Gene therapy medicinal product 25/09/2015
PDF iconAutologous 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
PDF iconAdeno-associated virus vector serotype rh10 encoding human factor IX

Treatment of haemophilia B

Gene therapy medicinal product 24/07/2015
PDF iconPeripheral 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
PDF iconAutologous engineered anti-CD19 Chimeric Antigen Receptor (CAR+) T-cells Treatment of various types of cancer Gene therapy medicinal product 17/07/2015
PDF iconIrradiated plasmacytoid dendritic cell line loaded with peptides from tumour antigens Treatment of metastatic cancer Somatic cell therapy medicinal product 13/05/2015
PDF iconAutologous human gamma-delta T lymphocytes Chronic Lymphocytic Leukaemia, Acute Lymphoblastic Leukaemia Somatic cell therapy medicinal product 13/05/2015
PDF iconAutologous 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
PDF iconAutologous mononuclear cells derived from human cord blood Paediatric brain damage, hypoxic-ischaemic encephalopathy, and cerebral palsy Tissue-engineered product 17/04/2015
PDF icon<i>Ex vivo</i> 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
PDF iconAutologous dendritic cells loaded with autologous irradiated tumour stem cells Treatment of melanoma Somatic cell therapy medicinal product 17/04/2015
PDF iconAdult stem cell population, prepared from human skeletal muscle Treatment of Duchenne Muscular Dystrophy (DMD) Tissue engineered product 30/03/2015
PDF icon<i>Ex vivo</i> PDF icon expanded adult human bone-marrow derived pooled allogeneic mesenchymal stromal cells Thromboangiitis obliterans (Buerger's disease) Somatic cell therapy medicinal product 27/02/2015
PDF iconHuman 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
PDF icon<i>Ex vivo</i> expanded adipose-derived stem cells suspension Autoimmune diseases (rheumatoid arthritis and systemic lupus erythematosus) Somatic cell therapy medicinal product 26/01/2015
PDF iconCultured 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
PDF iconAllogeneic 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
PDF icon<i>In vitro</i> derived platelets Haematology Not an advanced therapy medicinal product 24/11/2014
PDF iconAutologous differentiated adipocytes derived from the subcutaneous adipose tissue Intended for the treatment of primary perianal fistula Tissue-engineered product 24/11/2014
PDF iconAllogeneic, 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
PDF iconAllogeneic, 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
PDF iconAllogeneic, human Wharton's jelly derived mesenchymal stem cells Intended for the treatment of cartilage lesions Tissue engineered product 14/11/2014
PDF iconAllogeneic, human Wharton's jelly derived mesenchymal stem cells Intended for the treatment of cerebral palsy Tissue engineered product 14/11/2014
PDF iconAAV 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
PDF iconHuman 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
PDF iconMedicinal product composed of living, genetically modified <i>Lactococcus lactis</i> 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
PDF iconKilled spores of <i>Bacillus subtilis</i> incorporating a non-toxic antigen of <i>Clostridium difficile</i> 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
PDF iconAdeno-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
PDF iconAutologous mature dendritic cells pulsed with tumour antigen-derived synthetic peptides Intended for the treatment of glioblastoma Somatic cell therapy medicinal product 25/07/2014
PDF iconAllogeneic peripheral blood mononuclear cells induced to an early apoptotic state Intended for the treatment of glioblastoma Somatic cell therapy medicinal product 25/07/2014
PDF iconViral 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
PDF iconPlasmid 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
PDF iconDouble-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
PDF iconAutologous 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
PDF iconAllogeneic 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
PDF iconAutologous bone marrow cell aspirate in autologous plasma Intended for treatment of osteoarthrosis and osteochondral lesion Tissue-engineered product 28/05/2014
PDF iconTracheal 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
PDF iconAutologous 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
PDF iconViable 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
PDF iconAutologous lymphoid effector cells specific against tumour-cells Intended for treatment of solid tumours Somatic cell-therapy medicinal product 24/02/2014
PDF iconViable, 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
PDF iconAllogeneic activated leukocytes Intended for treatment of chronic lower extremity ulcers in adult diabetic patients Somatic cell-therapy medicinal product 21/01/2014
PDF iconEx-vivo expanded autologous skeletal myoblasts Intended for treatment of oculopharyngeal muscular dystrophy Tissue-engineered product 20/01/2014
PDF iconRetinal 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
PDF iconGenetically modified adenovirus coding for human granulocyte-macrophage colony stimulating factor (GM-CSF) Intended for treatment of cancer Gene-therapy medicinal product 20/12/2013
PDF iconEx-vivo expanded autologous human corneal epithelium containing stem cells Intended for treatment of limbal stem cell deficiency Tissue-engineered product 05/12/2013
PDF iconConcentrate 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
PDF iconHuman dermal fibroblasts cultured on bioresorbable polyglactin mesh Intended for treatment of wounds and ulcers Tissue engineered product 19/07/2013
PDF iconCultured 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
PDF iconMesenchymal 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
PDF iconAdenoviral 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
PDF iconAutologous dendritic cells activated with autologous oncolysate Intended for treatment of glioma Somatic cell therapy medicinal product 04/07/2013
PDF iconAdipose derived mesenchymal stem cells combined with beta-tricalcium phosphate Intended for treatment of bone defects. Tissue-engineered medicinal product – combined. 21/06/2013
PDF iconAutologous expanded CD34+ stem cells Intended for treatment of ccute myocardial infarction (AMI) via regeneration of damaged tissue Tissue-engineered product 23/05/2013
PDF iconHuman 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
PDF iconPseudomonas 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
PDF iconAllogeneic 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
PDF iconNaturally-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
PDF iconEBV-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
PDF iconAlginate encapsulated porcine pancreatic islet cells Intended for treatment of type 1 diabetes mellitus Somatic cell therapy medicinal product - combined 28/02/2013
PDF iconAdult 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
PDF iconAdult 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
PDF iconAllogeneic Mesenchymal Precursor Cells (MPCs) Intended for treatment of rheumatoid arthritis Somatic cell therapy medicinal product 28/01/2013
PDF iconTissue 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
PDF iconConcentrate 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
PDF iconAutologous mesenchymal stromal cells secreting NeuroTrophic factors Intended for treatment of amyothropic lateral sclerosis Somatic cell therapy medicinal product 18/12/2012
PDF iconAutologous skeletal muscle-derived-cells Intended for repair of deficient external anal sphincter in patients suffering from faecal incontinence Tissue-engineered product 28/11/2012
PDF iconAqueous 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
PDF iconHuman 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
PDF iconRecombinant 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
PDF iconBone 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
PDF iconAllogenic 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

PDF iconAutologous, 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
PDF iconAutologous 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
PDF iconAutologous 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
PDF iconAllogeneic human dermal fibroblasts

Intended for treatment of dermal scars, hypertrophic scars and contractures

Tissue-engineered product 31/05/2012
PDF iconAutologous oral mucosa cells seeded onto a membrane Intended for treatment of urethral stricture Tissue engineered product - combined 22/03/2012
PDF iconSuspension of oncolytic adenovirus Intended for treatment of colorectal cancer Not an advanced therapy medicinal product 22/03/2012

PDF iconBone 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
PDF iconA 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
PDF iconAutologous 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

PDF iconAutologous 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
PDF iconCD133+ 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
PDF iconConcentrate 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
PDF iconAutologous 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
PDF iconHuman 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
PDF iconAllogeneic 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

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