Table 1.
ATMP classification | Product | Manufacturer | Agency |
---|---|---|---|
Somatic cell therapy | Allogeneic cultured keratinocytes and fibroblasts in bovine collagen | Organogenesis | FDA |
Allogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low-affinity nerve growth factor receptor (DLNGFR) and the herpes simplex I virus thymidine kinase (HSV-TK Mut2) | MolMed Spa | EMA | |
Darvadstrocel | Takeda Pharma | EMA | |
Hematopoietic progenitor cell cord blood | Cleveland Cord Blood Center | FDA | |
SSM Cardinal Glennon Children’s Medical Center | |||
Bloodworks | |||
Clinimmune Labs, University of Colorado Cord Blood Bank | |||
Duke University School of Medicine | |||
LifeSouth Community Blood Centers | |||
New York Blood Center | |||
MD Anderson Cord Blood Bank | |||
Sipuleucel-T | Dendreon | FDA | |
Alofisel | Tigenix | EMA | |
Holoclar | Chiesi farmaceutici | EMA | |
Gene therapy | Autologous CD34+-enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human adenosine deaminase (ADA) cDNA sequence from human hematopoietic stem/progenitor (CD34+) cells | GlaxoSmithKline | EMA |
Imlygic | Amgen | EMA | |
Axicabtagene ciloleucel | Gilead Sciences | EMA | |
FDA | |||
Talimogene laherparepvec | Amgen | EMA | |
FDA | |||
Tisagenlecleucel | Novartis | EMA | |
FDA | |||
Luxturna | Spark Therapeutics | EMA | |
FDA | |||
Strimvelis | Orchard therapeutics | EMA | |
Zynteglo | Bluebird bio | EMA | |
Tissue-engineered products | Autologous cultured chondrocytes on a porcine collagen membrane-specific marker proteins | Chiesi Farmaceutici | EMA |
Spheroids of human autologous matrix-associated chondrocytes | Co.Don AG | EMA |
ATMP, advanced therapy medicinal products; EMA, European Medicines Agency; FDA, Food and Drug Administration.