Table 1A.
Recombinant GF-based products for regenerative medicine applications.
| Product | GF | Delivery system | Target tissue/disease | Approved authority | References |
|---|---|---|---|---|---|
| Augment® Bone Graft | PDGF-BB | Beta-tricalcium phosphate | Ankle fusion, hindfoot | FDA | FDA, 2015a |
| Increlex® | IGF-1 | Subcutaneous Injection | Primary IGF-1 deficiency | FDA | FDA, 2005; National Drug Strategy, 2006 |
| Infuse® Bone Graft | BMP-2 | Collagen sponge | Spinal fusion, bone regeneration | FDA | James et al., 2016 |
| Kepivance® | FGF-7 (KGF) | i.v. injection | Gastrointestinal injury | FDA | FDA, 2015b |
| OP-1® Putty | BMP-7 | Bovine bone-derived collagen | Spinal fusion, bone regeneration | FDA | Okabe et al., 2013 |
| PELNAC® | FGF-2 (bFGF) | Collagen sponge | Bedsores, cutaneous ulcers | Pharmaceuticals and Medical Devices Agency (Japan) | Kakudo et al., 2019 |
| REGEN-D® | EGF | Cellulose gel | Foot ulcer | Ministry of Food and Drug Safety (South Korea) | Frew et al., 2007 |
| Regranex® | PDGF-BB | Sodium carboxymethylcellulose-based topical gel | Chronic diabetic wound | FDA | FDA, 2008 |
| Citrix® CRS | TGF-β1 | Topical | Aged skin | Aldag et al., 2016 |
BMP, bone morphogenetic protein; EGF, epidermal growth factor; FGF, fibroblast growth factor; HGF, hepatocyte growth factor; IGF, insulin-like growth factor; PDGF, platelet-derived growth factor; TGF, transforming growth factor; FDA, U.S. Food Drug Administration.