Table 2.
Advanced therapy medicinal products (ATMPs) with a valid marketing authorisation.
| Trade name | Company | Authorised by | Cell type | Indication |
|---|---|---|---|---|
| Carticelb | Genzyme (Sanofi Biosurgery) | FDA (1997) | Autologous cultured chondrocytes | For the repair of symptomatic cartilage defects of the femoral condyle (medial, lateral, or trochlea) caused by acute or repetitive trauma in patients who have had an inadequate response to a prior arthroscopic or other surgical repair procedure |
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| Chondrond | Sewon Cellontech Co., Ltd. | KFDA (2001) | Autologous chondrocyte implantation | Articular cartilage defects |
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| Articelld | Duplogene | KFDA (2002) | Autologous cultured chondrocytes | Articular cartilage defects |
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| Halodermd | Tego Science | KFDA (2002) | Cultured epidermal autograft | Burn wounds |
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| Kalodermad | Tego Science | KFDA (2005) | Allogeneic keratinocyte sheet | Burn wounds |
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| JACEe | J-TEC (Japan Tissue Engineering Co., Ltd.) | Japan's Ministry of Health, Labour & Welfare (2007) | Autologous cultured epidermis | Burn wounds |
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| Chondrocelectc | Tigenix, Belgium | EMA (2009) | Autologous cultured chondrocytes | In adults to repair damage to the cartilage in the knee |
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| Provengeb | Dendreon Corporation | FDA (2010) EMA (2013) |
Autologous PB-MNS activated with FAP-GM-CSF (sipuleucel-T) | In autologous cellular immunotherapy for the treatment of asymptomatic or minimally symptomatic metastatic castration-resistant (hormone refractory) prostate cancer |
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| LaVivb | Fibrocell Technologies, Inc. | FDA (2011) | Autologous cultured fibroblasts (azficel-T) | Indicated for the improvement of the appearance of moderate to severe nasolabial fold wrinkles in adults |
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| Hemacordb | New York Blood Center, Inc. | FDA (2011) | Allogeneic HPC, cord blood | For use in unrelated donor haematopoietic progenitor cell transplantation procedures in conjunction with an appropriate preparative regimen for haematopoietic and immunological reconstitution in patients with disorders affecting the haematopoietic system that are inherited or acquired or that result from myeloablative treatment |
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| Glyberaa | UniQure Biopharma B.V., Netherlands | EMA (2012) | Alipogene tiparvovec | To treat adults with lipoprotein lipase deficiency who have severe or multiple attacks of pancreatitis (inflammation of the pancreas) despite maintaining a low-fat diet |
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| Gintuitc | Organogenesis Incorporated | FDA (2012) | Allogeneic cultured keratinocytes and fibroblasts in bovine collagen | Allogeneic cellularized scaffold product indicated for topical (nonsubmerged) application to a surgically created vascular wound bed in the treatment of mucogingival conditions in adults |
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| Ducordb | Duke University School of Medicine | FDA (2012) | Allogeneic HPC, cord blood | For use in unrelated donor haematopoietic progenitor cell transplantation procedures in conjunction with an appropriate preparative regimen for haematopoietic and immunological reconstitution in patients with disorders affecting the haematopoietic system that are inherited or acquired or that result from myeloablative treatment |
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| JACCe | J-TEC (Japan Tissue Engineering Co., Ltd.) | Japan's Ministry of Health, Labour & Welfare (2012) | Autologous cultured cartilage | Articular cartilage defects |
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| MACIc | Genzyme (Sanofi Biosurgery) | EMA (2013) | Matrix-induced autologous cultured chondrocytes | For implant to repair cartilage defects at the ends of the bones of the knee joint |
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| Allocordb | SSM Cardinal Glennon Children's Medical Center | FDA (2013) | Allogeneic HPC, cord blood | For use in unrelated donor haematopoietic progenitor cell transplantation procedures in conjunction with an appropriate preparative regimen for haematopoietic and immunological reconstitution in patients with disorders affecting the haematopoietic system that are inherited or acquired or that result from myeloablative treatment |
FAP-GM-CSF: prostatic acid phosphatase granulocyte-macrophage colony-stimulating factor; HPC: haematopoietic progenitor cells; PB-MNS: peripheral blood mononuclear cells.
aGTMP: gene therapy medicinal product; bSCTMP: somatic cell therapy medicinal product; cTEMP: tissue-engineered medicinal product; dbiotechnology-based product (KFDA Classification); emedical devices (Japan Classification).