Skip to main content

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.