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. |