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Table 1 Summary of cell therapies examined

From: Challenges in the translation and commercialization of cell therapies

Product Current Owner Type Cell Source Clinical Indication Nature of FDA Approval(s) and year(s)
Epicel Vericel Autologous Patient’s own skin Deep dermal burns Unregulated device (1988)
Humanitarian use device (2007)
Carticel Vericel Autologous Patient’s own cartilage Cartilage defects PHS Act, Section 351 (1997)
Provenge Valeant Autologous Patient’s own immune cells Advanced prostate cancer PHS Act, Section 351 (2010)
Apligraf Organogenesis Allogeneic Skin cells from human foreskin derived neonatal fibroblasts Venous leg ulcers (VLU) and diabetic foot ulcers (DFU) PHS Act, Section 351 (1998 for VLU, 2000 for DFU)
Dermagraft Organogenesis Allogeneic Skin cells from human foreskin derived neonatal fibroblasts Diabetic foot ulcers PHS Act, Section 351 (2001)
Osteocel NuVasive Allogeneic Mesenchymal stem cells & osteoprogenitor cells Bone regeneration as part of spinal surgery PHS Act, Section 361
Prochymal Mesoblast Allogeneic Mesenchymal stem cells derived from adult bone marrow Graft vs host disease Compassionate Use (2005). Not approved for general use in US.