Recombinant Platelet-Derived Growth Factor in Tissue Repair: A Review Exploring Frontiers in Regenerative Medicine.

summaryPure platelet-derived growth factor BB (PDGF-BB) enhances healing in multiple tissues and is the most thoroughly studied growth factor in medicine. Beyond the thousands of nonclinical studies that define its mechanism of action in tissue repair, more than 140 published human clinical studies have examined the safety and effectiveness of PDGF-BB therapeutics. Manufactured pure PDGF-BB mimics the biologic activity of the endogenous protein and is the active ingredient in 4 US Food and Drug Administration (FDA)-approved products used for the regeneration of skin, bone, mucosa, and gingiva, a diverse array of tissues important to reconstructive surgeons. The recent introduction of an FDA-registered product for use in medical aesthetics demonstrates interest in using this beneficial growth factor more broadly for skin rejuvenation and scar reduction. The authors review the history of clinical development of recombinant pure PDGF-BB, summarize the evidence from more than 30 years of translational research on the applications of PDGF-BB, and propose areas of unmet needs where pure PDGF-BB could potentially enhance patient outcomes. For this review, a literature search was conducted searching PubMed, Web of Science, Google, and clinicaltrials.gov . Evidence-based data from phase 1, 2, 3, and 4 FDA trials including more than 15,000 patients were extracted from systematic reviews and additional primary studies not referenced in systematic reviews. This summary of evidence supports the safety and efficacy of pure PDGF-BB therapeutics in wound healing and tissue repair, can help guide health care providers on the beneficial use of PDGF-BB applications, and provides a framework for future studies to further investigate PDGF-BB in regenerative medicine.