Summaries of scientific recommendations on classification of advanced therapy medicinal products

  • Email
  • Help

The European Medicines Agency's Committee for Advanced Therapies 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.

For more information, see

Product descriptionTherapeutic areaClassificationDate of adoption of recommendation
Bone marrow-derived autologous non-haematopoietic stem cellsIntended for the treatment of multiple sclerosisTissue engineered product13/10/2016
Autologous anti-BCMA CAR-T cellsIntended for the treatment of multiple myeloma and B cell lymphomaGene therapy medicinal product13/10/2016
Wharton jelly derived allogeneic mesenchymal stem cells, cultured in vitroIntended for the treatment of acute myocardial infarction, chronic ischaemic heart failure, no-option critical limb ischaemiaTissue engineered product13/10/2016
Recombinant modified vaccinia virus ankara (MVA) containing genetic sequences coding for the human mucin 1 and the human interleukin 2Intended for the treatment of advanced non-squamous non-small cell lung cancer (NSCLC)Gene therapy medicinal product13/10/2016
Autologous human adipose mesenchymal stromal cells, expanded in cultureIntended for cardiac repairTissue engineered product13/10/2016
Autologous skin cell suspensionIntended for burn wound treatment, donor site treatmentTissue engineered product13/10/2016
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 cancerGene therapy medicinal product13/10/2016

Living, genetically modified Lactobacillus reuteri  bacteria, with a plasmid containing the gene for human CXCL12-1a with an inducible promoter; and an activating peptide

Intended for treatment of chronic skin wounds in diabetic patients

Gene therapy medicinal product16/09/2016
Human autologous stromal vascular fraction cells and human autologous adipose-derived mesenchymal stem cells

Intended for treatment of cutis laxa senilis

Tissue engineered product16/09/2016

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 product16/09/2016

Autologous T-cells expressing a chimeric NKG2D receptor

Intended for treatment of various tumour types

Gene therapy medicinal product16/09/2016
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 18Intended for treatment of HPV-16 and -18 related high-grade squamous intraepithelial lesions (HSIL) of the cervix and vulvaGene therapy medicinal product16/09/2016
Ex-vivo cultured and expanded human cord blood progenitor cellsIntended for the treatment of patients undergoing hematopoietic stem cell transplantationTissue-engineered product19/07/2016
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 product19/07/2016
Recombinant adeno-associated viral vector serotype 2 encoding the human aromatic L-amino acid decarboxylase geneIntended for the treatment of Parkinson’s diseaseGene therapy medicinal product19/07/2016 
Heterologous human adult liver-derived progenitor cellsIntended for the treatment of fibro-inflammatory liver diseasesTissue-engineered product19/07/2016
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 product23/03/2016
Adenovirus serotype 5 expressing the Core protein, the Polymerase protein and selected domains of the Envelope protein of Hepatitis B virusIntended for the treatment of chronic hepatitis BNot an advanced therapy medicinal product03/03/2016
Co-culture of keratinocytes and mesenchymal stem cells isolated from human burn eschar and debrided adipose tissue cells, seeded onto acellular dermal matrixIntended for the treatment of deep and extensive burns, chronic wounds and skin donor sitesTissue-engineered product03/03/2016
Co-culture of keratinocytes and mesenchymal stem cells isolated from human burn eschar and debrided adipose tissue cells, seeded onto acellular amniotic matrixIntended for the treatment of deep and extensive burns, chronic wounds and skin donor sitesTissue-engineered product03/03/2016
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 cancerGene therapy medicinal product03/03/2016
Ex vivo expanded autologous Epstein-Barr Virus specific T-cells derived from peripheral blood mononuclear cellsIntended for the treatment of Epstein-Barr Virus (EBV) positive malignanciesSomatic cell therapy medicinal product03/03/2016
Adeno-associated virus serotype 2 based vector containing the human RPE65 gene expression cassetteIntended for the treatment of inherited retinal degeneration due to autosomal recessive RPE65 gene mutationsGene therapy medicinal product29/01/2016
Autologous blood-derived cells filtered to remove other blood componentsIntended for the treatment of critical limb ischemia (CLI)Tissue-engineered product22/01/2016
Human adult allogenic mesodermal progenitor cellsIntended for the treatment of incomplete revascularisation as an adjunct to CABG in patients with congenital coronary artery malformationsTissue-engineered product29/01/2016
Co-culture of keratinocytes and human amniotic membranemesenchymal stem cells as seeded on acellular amniotic matrixIntended for the treatment of burns, scars, non-healing woundsTissue-engineered product29/01/2016
Mesenchymal stem cells isolated from umbilical cord as a sheetIntended for the treatment of burns, non-healing woundsTissue-engineered product29/01/2016
Mesenchymal stem cells isolated from umbilical cord suspended in autologous platelet rich plasmaIntended for the treatment of burns, non-healing woundsTissue-engineered product29/01/2016
Mesenchymal stem cells isolated from umbilical cord seeded acellular amniotic matrixIntended for the treatment of burns, non-healing woundsTissue-engineered product29/01/2016
Mesenchymal stem cells isolated from umbilical cord seeded onto acellular dermal matrix Intended for the treatment of burns, non-healing woundsTissue-engineered product29/01/2016
Co-culture of keratinocytes and mesenchymal stem cells isolated from umbilical cord seeded on acellular amniotic matrixIntended for the treatment of burns and non-healing woundsTissue-engineered product29/01/2016 
Co-culture of keratinocytes and mesenchymal stem cells isolated from umbilical cord seeded on acellular dermal matrixIntended for the treatment of burns and non-healing woundsTissue engineered product29/01/2016
Co-culture of keratinocytes and human amniotic membrane mesenchymal stem cells as seeded on acellular dermal matrixIntended for the treatment of burns, scars, non-healing woundsTissue-engineered product29/01/2016
Ex vivo expanded adipose-derived stem cell suspension in a pre-filled syringe for autologous applicationAutoimmune diseases (rheumatoid arthritis and systemic lupus erythematosus)Somatic cell therapy medicinal product26/01/2016
Human amniotic membrane mesenchymal stem cells seeded on acellular dermal matrixIntended for the treatment of burns, scars, non-healing woundsTissue-engineered product29/01/2016
Human amniotic membrane mesenchymal stem cells seeded on acellular amniotic matrixIntended for the treatment of burns, scars, non-healing woundsTissue-engineered product29/01/2016
Human amniotic membrane mesenchymal stem cells in suspensionIntended for the treatment of burns, scars, non-healing woundsTissue-engineered product29/01/2016
Human amniotic membrane mesenchymal stem cells as a sheetIntended for the treatment of burns, scars, non-healing woundsTissue-engineered product29/01/2016
Decellularized porcine dermal matrixIntended for the treatment of various skin injuriesThe product does not fall within the definition of an advanced therapy medicinal product22/01/2016
Co-culture of keratinocytes and mesenchymal stem cells isolated from umbilical cord seeded on transgenic porcine acellular dermal matrixIntended for the treatment of deep and extensive burns, chronic wounds, skin donor sitesTissue-engineered product - combined22/01/2016
Co-culture of keratinocytes and mesenchymal stem cells isolated from umbilical cord seeded on acellular amniotic matrixIntended for the treatment of deep and extensive burns, chronic wounds, skin donor sitesTissue-engineered product22/01/2016
Co-culture of keratinocytes and mesenchymal stem cells isolated from umbilical cord seeded on acellular dermal matrixIntended for the treatment of deep and extensive burns, chronic wounds, skin donor sitesTissue-engineered product22/01/2016
Adeno-associated virus serotype 8 vector encoding human ornithine transcarbamylaseIntended for the treatment of ornithine transcarbamylase deficiencyGene therapy medicinal product21/12/2015
Bone marrow-derived autologous non-hematopoietic stem cellsIntended for the treatment of type I diabetesSomatic cell therapy medicinal product21/12/2015
Bone marrow-derived autologous non-hematopoietic stem cellsIntended for the treatment of type II diabetesSomatic cell therapy medicinal product21/12/2015
Bone marrow-derived autologous non-hematopoietic stem cellsIntended for the treatment of patients after myocardial infarctionTissue-engineered product21/12/2015
Bone marrow-derived autologous non-hematopoietic stem cells

Intended for the treatment of patients after ischemic stroke

Tissue-engineered product21/12/2015
Bone marrow-derived autologous non-hematopoietic stem cells

Intended for the treatment of rheumatoid arthritis

Somatic cell therapy medicinal product21/12/2015
Human hepatoblastoma cells (HepG2) encapsulated in alginate, expanded to competence and maintained in a fluidised bed bioreactorIntended for the treatment of acute liver failureSomatic cell therapy medicinal product - combined21/12/2015
Autologous cells of stromal vascular fraction of adipose tissueIntended for the treatment of pain associated with joint osteoarthritisSomatic cell therapy medicinal product25/11/2015
Autologous cells of stromal vascular fraction of adipose tissue

Intended for the treatment of non-healing wounds and scarred tissue

Tissue-engineered product25/11/2015
Adipose derived regenerative cells encapsulated in hyaluronic acidTreatment of articular cartilage and bone defects including osteoarthrosis or osteochondral lesionsTissue-engineered medicinal product - combined25/11/2015
Autologous expanded viable chondrocytes in a cross-linked hydrogelIntended for the treatment of articular cartilage defectTissue-engineered product (combined)28/10/2015
Allogeneic mesenchymal precursor cellsIntended 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 product28/10/2015
Autologous expanded mesenchymal cells seeded onto an allogeneic human decellularised trachea scaffoldIntended for the reconstruction of trachea subsequent to damage or stenosis due to cancer, injury, infection or congenital deformitiesTissue-engineered product28/10/2015
Allogeneic (human Wharton’s jelly derived) mesenchymal stem cellsIntended for the treatment of amyotrophic lateral sclerosis (ALS)Somatic cell therapy product27/10/2015
Autologous adipose tissue derived mesenchymal stem cellsIntended for the treatment of amyotrophic lateral sclerosis (ALS)Somatic cell therapy product27/10/2015
Autologous bone marrow derived mesenchymal stem cellsIntended for the treatment of amyotrophic lateral sclerosis (ALS)Somatic cell therapy product27/10/2015
Cryopreserved allogeneic hematopoietic progenitor cells (HPC–CD34+) accompanied by facilitating cells (FC– CD8+/abTCR-) and ab T cells, prepared from mobilized peripheral blood mononuclear cellsIntendedfor 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 transplantationNot an advanced therapy medicinal product16/10/2015
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 Listeria monocytogenes expressing human mesothelin

Treatment of malignant pleural mesothelioma

Gene therapy medicinal product25/09/2015
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 ischemiaTissue-engineered product24/07/2015
Adeno-associated virus vector serotype rh10 encoding human factor IX

Treatment of haemophilia B

Gene therapy medicinal product24/07/2015
Peripheral blood monocytes-derived suppressive cellsTreatment of acute Graft-versus-Host Disease refractory to first-line treatmentSomatic cell therapy medicinal product17/07/2015
Autologous engineered anti-CD19 Chimeric Antigen Receptor (CAR+) T-cellsTreatment of various types of cancerGene therapy medicinal product17/07/2015
Irradiated plasmacytoid dendritic cell line loaded with peptides from tumour antigensTreatment of metastatic cancerSomatic cell therapy medicinal product13/05/2015
Autologous human gamma-delta T lymphocytesChronic Lymphocytic Leukaemia, Acute Lymphoblastic LeukaemiaSomatic cell therapy medicinal product13/05/2015
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 cellsTreatment of Peripheral Arterial Occlusive Disease (PAOD)Tissue-engineered product17/04/2015
Autologous mononuclear cells derived from human cord bloodPaediatric brain damage, hypoxic-ischaemic encephalopathy, and cerebral palsyTissue-engineered product17/04/2015
Ex vivo expanded human umbilical tissue-derived cellsImprovement of visual acuity in patients with vision loss from geographic atrophy secondary to age-related macular degenerationSomatic cell therapy medicinal product17/04/2015
Autologous dendritic cells loaded with autologous irradiated tumour stem cellsTreatment of melanomaSomatic cell therapy medicinal product17/04/2015
Adult stem cell population, prepared from human skeletal muscleTreatment of Duchenne Muscular Dystrophy (DMD)Tissue engineered product30/03/2015
Ex vivo expanded adult human bone-marrow derived pooled allogeneic mesenchymal stromal cellsThromboangiitis obliterans (Buerger’s disease)Somatic cell therapy medicinal product27/02/2015
Human extracellular matrix proteins (mainly Collagen I and glycosaminoglycans) and residual absorbable polymer, supplied as a lyophilized (dry) and ethylene-oxide sterilised productSurgical or interventional treatment of congenital heart defects, thereby correcting anatomic malformationsThe product does not fall within the definition of an advanced therapy medicinal product20/02/2015
Living, autologous, melanoma-derived lymphocytes (CD3+)Therapeutic treatment of metastatic melanoma in patients pre-conditioned with chemotherapy and undergoing concomitant interleukin-2 (IL-2) treatmentSomatic cell therapy medicinal product26/01/2015
Ex vivo expanded adipose-derived stem cells suspensionAutoimmune diseases (rheumatoid arthritis and systemic lupus erythematosus)Somatic cell therapy medicinal product26/01/2015
Cultured autologous chondrocytes in fibrin based excipient of human originIntended for the treatment of focal non-arthritic cartilage defects of Outerbridge Classification Grade III or IV of the femoral condyle including the trochleaTissue-engineered product17/12/2014
Allogeneic cord blood cells, modulated with 16,16 dimethyl prostaglandin E2Intended for the treatment of patients undergoing an haematopoietic stem cell transplantationTissue-engineered product24/11/2014
In vitro derived plateletsHaematologyNot an advanced therapy medicinal product24/11/2014
Autologous differentiated adipocytes derived from the subcutaneous adipose tissueIntended for the treatment of primary perianal fistulaTissue-engineered product24/11/2014
Allogeneic, human Wharton’s jelly derived mesenchymal stem cellsIntended for the treatment of Amyotrophic lateral sclerosis (ALS)Somatic cell therapy medicinal product14/11/2014
Allogeneic, human Wharton’s jelly derived mesenchymal stem cellsIntended for the treatment acute and chronic Graft-versus-Host DiseaseSomatic cell therapy medicinal product14/11/2014
Allogeneic, human Wharton’s jelly derived mesenchymal stem cellsIntended for the treatment of cartilage lesionsTissue engineered product14/11/2014
Allogeneic, human Wharton’s jelly derived mesenchymal stem cellsIntended for the treatment of cerebral palsyTissue engineered product14/11/2014
AAV vector carrying an expression cassette for photoactivable enhanced halorhodopsin protein from Natronomonas pharaonis (eNpHR)Intended for the treatment of Retinitis PigmentosaGene therapy medicinal product29/10/2014
Human retinal pigment epithelial cells derived from human embryotic stem cellsIntended for the treatment of age-related macular degeneration and Stargardt’s macular dystrophyTissue-engineered product29/10/2014
Medicinal product composed of living, genetically modified Lactococcus lactis bacteria, containing the gene for anti-human tumor necrosis factor-alpha proteinIntended 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 product17/10/2014
Killed spores of Bacillus subtilis incorporating a non-toxic antigen of Clostridium difficileIntended for the prevention of Clostridium difficile infections in elderly patientsThe 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 transcriptsIntended for the treatment of autosomal dominant rhodopsin-linked retinitis pigmentosaGene therapy medicinal product25/07/2014
Autologous mature dendritic cells pulsed with tumour antigen-derived synthetic peptidesIntended for the treatment of glioblastomaSomatic cell therapy medicinal product25/07/2014
Allogeneic peripheral blood mononuclear cells induced to an early apoptotic stateIntended for the treatment of glioblastomaSomatic cell therapy medicinal product25/07/2014
Viral solution for injection of HSV-1 derived oncolytic virusIntended for the treatment of advanced pancreatic cancer and / or unresectable hepatocellular carcinomaGene therapy medicinal product02/07/2014
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 IgG3Intended for prevention and treatment of HPV16 induced pre-malignancies and malignanciesGene therapy medicinal product27/06/2014
Double-stranded naked DNA plasmid encoding an inactive human telomerase reverse transcriptase protein fused to ubiquitinIntended for the treatment of various malignancies and the prevention of tumour relapseGene therapy medicinal product27/06/2014
Autologous bone marrow aspirate enriched in autologous mesenchymal stromal cellsIntended for treatment in the field of regenerative medicine: bone damaged by disease (e.g. osteonecrosis), fracture or age-related loss of bone functionTissue-engineered product20/06/2014
Allogeneic engineered Chimeric Antigen Receptor (CAR+) T-cellsIntended for treatment of acute lymphoblastic leukemia and chronic lymphocytic leukemiaGene-therapy medicinal product28/05/2014
Autologous bone marrow cell aspirate in autologous plasmaIntended for treatment of osteoarthrosis and osteochondral lesionTissue-engineered product28/05/2014
Tracheal scaffold seeded with autologous bone marrow derived mononuclear cellsIntended for reconstruction of trachea subsequent to damage or stenosis due to cancer, injury or infectionTissue-engineered product - combined28/05/2014
Autologous antigen-specific regulatory T lymphocytes suspended in a cryopreservation mediumIntended for the treatment of inflammatory eyes diseases and inflammatory articular diseasesSomatic cell therapy medicinal product14/05/2014
Viable autologous adipose tissue-derived mesenchymal stem cellsIntended for the treatment of degenerative arthritis, osteoarthritis (OA), articular cartilage defects in the knee, ankle or hip jointsTissue engineered product14/05/2014
Autologous lymphoid effector cells specific against tumour-cellsIntended for treatment of solid tumoursSomatic cell-therapy medicinal product24/02/2014
Viable, autologous keratinocytes and melanocytes grown on AS210 matrix. The active component of tissue engineered dermis consists of viable, autologous fibroblastsIntended for wound healingTissue-engineered product22/01/2014
Allogeneic activated leukocytesIntended for treatment of chronic lower extremity ulcers in adult diabetic patientsSomatic cell-therapy medicinal product21/01/2014
Ex-vivo expanded autologous skeletal myoblastsIntended for treatment of oculopharyngeal muscular dystrophyTissue-engineered product20/01/2014
Retinal pigment epithelium cells derived from human induced pluripotent stem cellsIntended for treatment of retinal degenerative diseases associated with dystrophic or dysfunctional retinal pigment epithelium cellsTissue-engineered product20/01/2014 
Genetically modified adenovirus coding for human granulocyte-macrophage colony stimulating factor (GM-CSF)Intended for treatment of cancerGene-therapy medicinal product20/12/2013
Ex-vivo expanded autologous human corneal epithelium containing stem cellsIntended for treatment of limbal stem cell deficiencyTissue-engineered product05/12/2013
Concentrate of autologous, uncultured, custom-prepared bone marrow aspirateIntended for treatment of avascular necrosis e.g. of the femur headNot an advanced therapy medicinal product19/07/2013
Human dermal fibroblasts cultured on bioresorbable polyglactin meshIntended for treatment of wounds and ulcersTissue engineered product19/07/2013
Cultured mesenchymal stem cells suspension extracted from bone (Ilium) marrowIntended for treatment of chronic myocardial ischemia with left ventricular dysfunctionTissue-engineered medicinal product19/07/2013
Mesenchymal stem cells extraction from bone (Ilium) marrow, cultured and preheated by melatoninIntended for treatment of chronic myocardial ischemia with left ventricular dysfunctionTissue-engineered medicinal product19/07/2013
Adenoviral vector expressing the non-structural region of hepatitis C virus (HCV) in which a mutation has been introducedIntended for prevention and treatment of HCV and HCV-induced hepatocellular carcinomaNot an advanced therapy medicinal product19/07/2013
Autologous dendritic cells activated with autologous oncolysateIntended for treatment of gliomaSomatic cell therapy medicinal product04/07/2013
Adipose derived mesenchymal stem cells combined with beta-tricalcium phosphateIntended for treatment of bone defects.Tissue-engineered medicinal product – combined.21/06/2013
Autologous expanded CD34+ stem cellsIntended for treatment of ccute myocardial infarction (AMI) via regeneration of damaged tissueTissue-engineered product23/05/2013
Human autologous tumour-infiltrating lymphocytes (TIL)Intended for treatment of stage III melanoma with one invaded lymph nodeSomatic cell therapy medicinal product19/04/2013
Pseudomonas aeruginosa bacteria genetically modified to secrete oncoproteins of Merkel cell carcinomaIntended for treatment of merkel cell carcinomaGene-therapy medicinal product12/04/2013
Allogeneic bone marrow derived mesenchymal cells (MSCs) expanded ex vivo in synthetic mediaIntended for treatment of patients with acute graft-versus-host disease grades III and IV resistant to first line treatmentSomatic cell therapy medicinal product12/04/2013
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 diseasesSomatic cell therapy medicinal product12/04/2013
EBV-specific T cells in suspension in human albuminIntended for the treatment of prophylactic or curative adoptive immunotherapy of EBV-associated malignant diseasesSomatic cell-therapy medicinal product19/03/2013
Alginate encapsulated porcine pancreatic islet cellsIntended for treatment of type 1 diabetes mellitusSomatic cell therapy medicinal product - combined28/02/2013
Adult Autologous Regenerative Cells for Subcutaneous AdministrationIntended for regeneration, repair, or replacement of weakened or injured subcutaneous tissueNot an advanced therapy medicinal product15/02/2013
Adult Autologous Regenerative Cells in Autologous Cell-Enriched Matrix for Subcutaneous AdministrationIntended for regeneration, repair, or replacement of weakened or injured subcutaneous tissueNot an advanced therapy medicinal product15/02/2013
Allogeneic Mesenchymal Precursor Cells (MPCs)Intended for treatment of rheumatoid arthritisSomatic cell therapy medicinal product28/01/2013
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 defectsTissue engineered medicinal product18/12/2012
Concentrate of autologous bone marrowIntended for increase new bone formation in critical area of atrophic non-unionTissue engineered medicinal product, combined ATMP18/12/2012
Autologous mesenchymal stromal cells secreting NeuroTrophic factorsIntended for treatment of amyothropic lateral sclerosisSomatic cell therapy medicinal product18/12/2012
Autologous skeletal muscle-derived-cellsIntended for repair of deficient external anal sphincter in patients suffering from faecal incontinenceTissue-engineered product28/11/2012
Aqueous suspension of attenuated Salmonella typhi Ty21a strain transfected with a plasmid vector encoding for the human vascular endothelial growth factor receptor 2Intended for treatment of solid malignancies with or without metastasesGene therapy medicinal product28/11/2012
Human ciliary neurotrophic factor (CNTF)Intended for reducing photoreceptor loss associated with degeneration of the cells of the retinaGene therapy medicinal product - combined04/10/2012
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 melanomaGene therapy medicinal product09/08/2012
Bone marrow derived autologous suspensions of hematopoietic and mesenchymal stem cells depleted from erythrocytes and lymphocytesIntended for treatment of complete or incomplete traumatic spinal cord injuryTissue-engineered product09/07/2012
Allogenic and autologous haptenised and irradiated cells and corresponding cell lysates derived from the tumour mass of patients diagnosed with glioblastoma multiformeIntended for treatment of glioblastoma multiformeSomatic cell therapy medicinal product31/05/2012

Autologous, non-manipulated lipoaspirate containing adipocytes and stromal vascular fraction

No medical or therapeutic claims pursued. Autologous lipofillerNot an advanced therapy medicinal product31/05/2012
Autologous cells of stromal vascular fraction (SVF) of adipose tissueNot medical or therapeutic claims pursued. Cosmetic lipofilling in combination with fresh lipoaspirateNot an advanced therapy medicinal product31/05/2012
Autologous collagen (AC) derived from human adipose tissueNo medical or therapeutic claims pursued. Cosmetic dermal fillingNot an advanced therapy medicinal product31/05/2012
Allogeneic human dermal fibroblasts

Intended for treatment of dermal scars, hypertrophic scars and contractures

Tissue-engineered product31/05/2012
Autologous oral mucosa cells seeded onto a membraneIntended for treatment of urethral strictureTissue engineered product - combined22/03/2012
Suspension of oncolytic adenovirusIntended for treatment of colorectal cancerNot an advanced therapy medicinal product22/03/2012

Bone marrow-derived autologous CD34+ cells

Intended for improvement of heart function in patients with refractory angina and chronic myocardial ischemiaTissue-engineered product22/03/2012
A mixture of autologous dendritc cells (DCs) pulsed with a Non structural 3 (NS3) protein fragment of Hepatitis C Virus (HCV) and activated T-cellsIntended for treatment of patients with chronic HCV infectionSomatic cell therapy medicinal product23/02/2012
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 product19/12/2011
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 product19/12/2011

Autologous CD4+ T cells targeted to cells presenting class II restricted epitopes

Intended for autoimmune diseases with MHC restricted specific immunity e.g. multiple sclerosis, type I diabetes or graft rejection

Somatic cell therapy medicinal product23/11/2011
CD133+ stem cells derided autologous bone marrowIntended 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 MITissue-engineered product07/11/2011
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 diseaseTissue-engineered product07/11/2011
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 carcinomaSomatic cell therapy medical product14/10/2011
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 therapyTissue-engineered product - not combined29/07/2011
Human islets of LangerhansIntended for:
Autologous: Post pancreatectomy for benign pancreatic pathologies
Allogeneic: Treatment of severe forms of type 1 diabetes
Not an advanced therapy medicinal product29/07/2011
Allogeneic bone-marrow derived osteoblastic cellsIntended for treatment of non-union, delayed union or other bone fracturesTissue-engineered product - not combined01/07/2011
Live recombinant lentiviral vectors encoding HIV epitopes to be used for therapeutic HIV vaccination of HIV-1 infected patientsInfectious disease: HIV-1Not an advanced therapy medicinal product27/05/2011
Heterologous human adult liver-derived progenitor cellsIntended for treatment of inborn errors of liver metabolismSomatic cell therapy medicinal product - not combined05/05/2011
Allogeneic human fibroblasts cultured onto a biodegradable matrixDermatologyTissue engineered product - combined04/04/2011
Medicinal product composed of living, genetically modified Lactococcus lactis bacteria, containing the human trefoil factor 1 (hTFF1) geneIntended for prevention and treatment of chemotherapy-induced and/or radiotherapy-induced oral mucositis in patients with cancer of the head and the neckGene therapy medicinal product08/02/2011
Layer of autologous corneal epithelium containing stem cellsIntended for treatment of extended corneal lesionsTissue engineered product - not combined20/12/2010
Lentiviral vector expressing the naturally occurring human anti-angiogenic proteins endostatin and angiostatinIntended for treatment of age-related macular degenerationGene therapy medicinal product30/11/2010
Allogeneic human aortic endothelial cells cultured in a porcine gelatin matrixIntended for treatment of vascular injurySomatic cell therapy medicinal product - not combined04/10/2010
Non-integrative vector including a gene coding for an anti-HSV-1 meganuclease for the ex-vivo transduction of human corneaIntended for prevention of infectious diseases in cornea grafted patientsGene therapy medicinal product04/10/2010
Adult skeletal muscle derived cellsIntended for treatment of female stress urinary incontinenceTissue engineered product - not combined04/10/2010
Allogeneic human placenta-derived, culture-expanded, mesenchymal-like cell populationIntended for treatment of chronic inflammatory diseases such as Crohn’s disease, multiple sclerosis, rheumatoid arthritis and the treatment of ischaemic strokeSomatic cell therapy product04/10/2010
Autologous bone marrow-derived progenitor cellsIntended 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 diseaseTissue engineered product04/10/2010
Allogeneic mesenchymal precursor cellsIntended for treatment of cardiovascular diseaseTissue engineered product05/08/2010
Umbilical cord blood cells expanded ex vivo using allogeneic mesenchymal precursor cellsIntended treatment of diseases in haematology-oncology therapeutic areaTissue engineered product05/08/2010
Frozen, cultured allogeneic keratinocytes on a silicone dressing materialIntended the treatment of acute burn woundsTissue engineered product - not combined05/08/2010
Autologous human keratinocytesIntended for treatment of superficial, partial and full thickness burnsTissue engineered product - not combined05/08/2010
Hollow fiber cartridges populated with the C3A cells to be used with ancillary support equipmentIntended for treatment of acute or chronic hepatitisSomatic cell therapy medicinal product - combined02/07/2010
Autologous ex-vivo pulsed dendritic cellsIntended for treatment of ovarian cancerSomatic cell therapy medicinal product02/07/2010
Mixture of porcine beta cell and their accompanying endocrine cell populations embedded in an alginate matrixEndocrinology: intended for treatment of diabetesSomatic cell therapy medicinal product - not combined02/07/2010
DNA plasmid encoding for the human fibroblast growth factor type 1 (FGF 1)Intended for treatment of critical limb ischaemiaGene therapy medicinal product12/05/ 2010
Allogeneic T cells encoding an exogenous TK geneIntended as adjunct treatment in haematopoietic stem cell transplantationSomatic cell therapy medicinal product02/03/2010
Allogeneic human dermal fibroblastsIntended for treatment of dystrophic epidermolysis bullosaTissue engineered product02/03/2010
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 diseaseGene therapy medicinal product02/03/2010
Genetically modified Lactococcus lactis secreting human interleukin-10Intended for treatment of inflammatory bowel diseaseGene therapy medicinal product12/02/2010
Autologous osteoprogenitor cells, isolated from bone marrow and expanded in vitro, incorporated, as an integral part, with 3D biodegradable scaffoldIntended for repairing and regenerating and replacing bone defects in odontostomatology and maxillofacial surgeryTissue engineered product - combined26/01/2010
Salmonella typhi strain genetically modified to secrete a fusion protein of the prostate specific antigen (PSA) and a protein leading to an increased antigenicityOncology: intended for treatment of prostate cancerGene therapy medicinal product26/01/2010
Product consisting of naturally occurring antigen-specific CD8+ donor lymphocytes isolated with streptamersIntended for treatment of infectious diseasesNot an advanced therapy medicinal product26/01/2010
Buffy coat of centrifuged autologous bone marrow containing haematopoietic and mesenchymal stem cells.Intended for treatment of incomplete and complete chronic traumatic spinal cord injuryAdvanced therapy medicinal product15/01/2010
Autologous cultured chondrocytes integrated in a scaffoldIntended for repair of symptomatic cartilage defects in joints such as the knee and ankleTissue engineered medicinal product - combined15/01/2010
Adenovirus encoding vascular endothelial growth factor C (VEGF-C).Intended for treatment of secondary lymphoedema associated with the treatment of breast cancerGene therapy medicinal product15/01/2010
Autologous cell therapy product.Intended for treatment of Crohn's diseaseSomatic cell therapy medicinal product15/01/2010
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 leukaemiaSomatic cell therapy medicinal product15/01/2010
Allogeneic cultured corneal epithelial cell sheet in amniotic membrane scaffoldIntended for the treatment of ocular diseasesTissue engineered product15/01/2010
Mesenchymal stem cell-derived microvesicles (containing receptors, proteins, lipids, mRNA and microRNA).Intended for treatment of renal diseasesNot an advanced therapy medicinal product04/12/2009
Lentiviral vector expressing the human MYO7A gene.Intended for the treatment of retinitis pigmentosaGene therapy medicinal product04/12/2009
Lentiviral vector expressing the ABCA4 gene, packaged into infectious VS virus envelope.Intended for the treatment of retinal disordersGene therapy medicinal product04/12/2009
Adeno-associated virus (AAV) vector containing a gene coding for N-sulfoglucosamine sulfohydrolaseIntended for treatment of congenital, hereditary, and neonatal diseases and abnormalitiesGene therapy medicinal product04/12/2009
Fresh and freeze - dried thrombocytes isolated from autologous or allogeneic bloodIntended for wound healing in orthopedic and dental surgeryNot an advanced therapy medicinal product13/11/2009
Autologous tolerogenic dendritic cells derived from peripheral blood monocytesIntended for treatment of rheumatoid arthritisSomatic cell therapy medicinal product. Not combined16/10/2009
A combination of lysates of tumour cells (autologous and allogenic) and living cells of a glioblastoma cell lineOncology: intended for treatment of glioblastomaSomatic cell therapy medicinal product16/10/2009
Haploidentical donor T lymphocytes genetically modified to express HSV-Tk geneOncology: intended as adjunctive treatment post bone marrow transplantation in patients with high risk acute leukaemiaSomatic cell therapy medicinal product16/10/2009
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 incontinenceTissue engineered product - not combined16/10/2009
Immunotherapeutic medicinal product composed of autologous tumour cellsOncology: intended for treatment of colon cancerSomatic cell therapy medicinal product.13/08/2009
Advanced therapy medicinal product containing substantially modified cytotoxic T-cells of human originOncology: intended for treatment of ovarian cancerSomatic cell therapy medicinal product.13/08/2009
Substantially modified human allogeneic fibroblasts and keratinocytes administered in conjunction with fibrin as structural componentDermatology: intended for treatment of chronic venous leg ulcersSomatic cell therapy medicinal product.19/06/2009

How useful is this page?

Average rating:

 Based on 22 ratings

Add your rating:

See all ratings
1 ratings
3 ratings
2 ratings
3 ratings
13 ratings