Safety of Exogenous Recombinant Human Platelet-Derived Growth Factor-BB (rhPDGF-BB) for Medical and Cosmetic Applications - A Review

Sep 28, 2026

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Recombinant human platelet-derived growth factor-BB (rhPDGF-BB, pure PDGF) is reviewed as a well-studied biologic with four FDA approvals for tissue regeneration, now expanding into esthetic/cosmetic uses. The review synthesizes extensive nonclinical and clinical pharmacokinetic and safety data across topical, injection, and surgical implantation routes to establish a large safety margin. Systemic exposure is negligible after repeated use, and toxicology shows no cytotoxicity, irritation, sensitization, genotoxicity, or carcinogenicity signals, with no detected cancer incidence or mortality in relevant dosing up to 20 weeks.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages6

Reading Time15 min

AccessFree to download

ABSTRACT

Background and Objective

Pharmacokinetics and Safety Results

Conclusion

Introduction

PDGF biology and FDA-approved products

Clinical use and relevance to medical esthetics

Journal of Cosmetic Dermatology Safety of Exogenous Recombinant Human Platelet-Derived Growth Factor-BB (rhPDGF-BB) for Medical and Cosmetic Applications: A Review Christopher K. Hee1 | Herbert B. Slade2 | Samuel E. Lynch1 1Lynch Regenerative Medicine, Franklin, Tennessee, USA | 2Chisholm Clinical Research Services, LLC, Ft. Worth, Texas, USA Correspondence: Samuel E. Lynch ([s.lynch@lynchregen.com](s.lynch@lynchregen.com)) Received: 10 October 2025 | Revised: 10 October 2025 | Accepted: 16 December 2025 ABSTRACT Background: Recombinant human platelet-derived growth factor-BB (rhPDGF-BB or pure PDGF) has been extensively studied in medicine, resulting in four FDA approvals for products based on pure PDGF for tissue regeneration applications, including stimulation of the healing of skin wounds in diabetic patients, stimulation of healing of intra-oral tissue defects, and stimulation of bone and tissue regeneration following foot and ankle arthrodesis surgery. More recently, pure PDGF has also been introduced for esthetic and cosmetic applications. Objective: Here, we review the extensive nonclinical and clinical pharmacokinetic and safety studies performed on rhPDGF-BB across diverse administration routes, including topical, injection, and surgical implantation to establish a large margin of safety. Results: Pharmacokinetic studies confirmed that systemic exposure to rhPDGF-BB is negligible following repeated topical application, injection, or implantation, minimizing any potential for systemic risks. Biocompatibility and toxicology studies demonstrated that rhPDGF-BB applied topically to skin, implanted, or injected subcutaneously, intradermally, intramuscularly, intraperitoneally, or intravenously, one time, or repeatedly, is noncytotoxic, nonirritating, nonsensitizing, nonmutagenic, nonclastogenic, noncarcinogenic, and nontoxic. No risk of cancer incidence or cancer mortality was detected following injection, implantation, or repeated, daily topical application of rhPDGF-BB onto partial or full thickness skin wounds for up to 20 weeks, that is, 140 doses. Conclusion: The totality of the data demonstrates that the use of rhPDGF-BB for regeneration and rejuvenation of skin and other tissues has an excellent safety profile, a finding further affirmed by its record of safe and effective use in multiple medical indications for over 25 years. 1 | Introduction Platelet-derived growth factor (PDGF) orchestrates vital processes involved in tissue regeneration, rejuvenation, and wound healing [1, 2] . The ability of PDGF to enhance these pathways has led to FDA approval of four products containing recombinant human pure PDGF BB (rhPDGF-BB or pure PDGF) used to treat a myriad of regenerative needs [3–7] . Pure PDGF has also recently received rapidly increasing use in medical esthetics. Given its rapid rise in popularity, questions have been raised regarding what studies demonstrate its safety for use in esthetic medicine. As with any product, the evaluation of safety should be a prerequisite to understand the potential risk for a given use. This review summarizes the extensive record of safe and effective use of rhPDGF-BB in medicine, highlighting those studies with the most relevance to the dermatology, plastic surgery, and This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited. © 2025 The Author(s). Journal of Cosmetic Dermatology published by Wiley Periodicals LLC. Journal of Cosmetic Dermatology, 2026; 25:e70636 1 of 6 [https://doi.org/10.1111/jocd.70636](https://doi.org/10.1111/jocd.70636) medical esthetics providers, thereby providing a comprehensive source of safety information for pure PDGF to which health care providers can refer. The four products containing rhPDGF-BB as the active ingredient that have been approved by the FDA following rigorous p

FAQs

What medical and cosmetic uses of rhPDGF-BB does the review focus on?

The review focuses on tissue regeneration in medicine and the expanding use of pure PDGF for esthetic and cosmetic applications, emphasizing safety evidence across multiple administration routes.

How does rhPDGF-BB behave systemically after repeated topical, injection, or implantation use?

Pharmacokinetic studies confirm negligible systemic exposure after repeated topical application, injection, or implantation, reducing concern for systemic risks.

What safety findings are reported across nonclinical and clinical studies?

Biocompatibility and toxicology studies indicate rhPDGF-BB is noncytotoxic, nonirritating, nonsensitizing, nonmutagenic, nonclastogenic, noncarcinogenic, and nontoxic, with no detected cancer incidence or cancer mortality in the described dosing contexts.

Sep 28, 2026

Uploaded by Pentious