The Heritage of PDGF

PDGF

Few molecules have had as profound and enduring an impact on regenerative science as platelet-derived growth factor (PDGF). From its discovery nearly half a century ago to its current place in patient care and scientific conversation in aesthetic medicine, poorly healing skin wounds, orthopedics, and dental surgical reconstruction, PDGF stands as both a milestone of molecular biology and a reminder of the professional responsibilities that accompany innovation.

A LEGACY ROOTED IN DISCOVERY

PDGF was first identified in the 1970s as a naturally occurring protein released by platelets at sites of injury, where it initiates signaling pathways that regulate cell proliferation, angiogenesis, and tissue regeneration.1 Its isolation marked a turning point in our understanding of wound healing at the molecular level and set the stage for an entirely new field: growth factor-based regenerative biology.

Over the ensuing decades, PDGF became one of the most extensively studied signaling proteins in medicine, with thousands of peer-reviewed publications (a PubMed search of the term yields nearly 20,000 results) exploring its biological mechanisms, safety, and effectiveness in the treatment of various clinical regenerative indications.2-9 This growing body of evidence ultimately led to PDGF’s first regulatory milestone in 1997, when recombinant human platelet-derived growth factor (rhPDGF-BB) was approved by the US Food and Drug Administration (FDA) for the treatment of poorly healing skin wounds in the lower extremities of diabetics. This was among the first examples of a recombinant growth factor moving from laboratory discovery to FDA approval and widespread clinical use.

After several more years of clinical trials, an additional formulation combining rhPDGF-BB and a beta-tricalcium phosphate (β-TCP) scaffold received FDA approval for regeneration of the soft and hard tissues of the periodontium. This success was followed by more years of research, development, and clinical trials that further established the safety and efficacy of rhPDGF-BB applied during surgery or injected into orthopedic defects, leading to more FDA approvals in surgical and tissue regeneration indications. Each of these pure PDGF  products represent decades of rigorous research, regulatory oversight, and multidisciplinary collaboration. Their development helped establish PDGF as a model for how biologically derived therapies can progress responsibly through the translational pipeline.

LESSONS FROM PDGF’S HERITAGE

PDGF’s history offers a roadmap for how biomedical innovation should unfold: with a continuing feedback loop between innovators and clinicians leading to achievement of  better outcomes for patients. Each stage of development, from cell culture studies to randomized clinical trials, is characterized by patience, peer-reviewed science, and real clinical outcomes—not social media anecdotes or fear mongering. 

The recent social media debate around PDGF illustrates how quickly conversation can outpace confirmation. The heritage of PDGF also underscores an essential truth about regenerative medicine: progress leaps forward when great clinicians use products grounded in strong science developed over decades. When speculation accelerates ahead of evidence, the scientific method itself can be overshadowed. It is a fact that rhPDGF-BB is backed by decades of clinical use. It has been trusted in 4 FDA-approved medical treatments (GEM 21S®, Lynch Regenerative Medicine and Lynch Biologics; Augment®, Stryker; Augment® Injectable, Stryker; and REGRANEX®, Lynch Regenerative Medicine) and used safely and effectively in millions of patients during the last 28 years. To claim that injection of rhPDGF-BB into intact skin has not been tested would be inconsistent with the scientific literature.  These are not opinions; they are verifiable data points.

The legacy of PDGF reminds us that medical innovation thrives on rigorous scientific inquiry coupled with clinical judgement, not merely opinions.

ETHICAL FRAMEWORKS FOR EMERGING SCIENCE

Responsible advancement in regenerative science depends on three ethical pillars: independent medical judgement by trained, licensed medical professionals; integrity; and collaboration.

Independent medical judgement allows clinicians and researchers to pursue new ideas without distortion or fear of retaliation. An example is ariessence® pure PDGF+ when used as a topical cosmetic product: licensed health care professionals have discovered ways of incorporating it into aesthetic treatments that had not been previously realized.

Integrity requires transparency about known facts, hypotheses, and knowledge gaps—and, equally, diligence to avoid hyperbole or distortion of facts, deliberate or otherwise.

Collaboration ensures that academia, industry, and health care professionals share data openly, collegially, and constructively, avoiding accusations and exaggerated threats against other licensed medical professionals with whom they might disagree, all while keeping at the center of attention that which is best for our patients.

PDGF’s journey from discovery, through exhaustive nonclinical biological and safety testing on almost every major organ including wounded or intact skin, clinical trials, regulatory approvals, and use by licensed health care providers making decisions daily regarding the best care for their patients, exemplifies these principles. Across multiple medical disciplines, every milestone was shaped by multidisciplinary teams working within ethical and evidentiary boundaries. Research has been and continues to be published in peer-reviewed scientific and medical journals so that other professionals within the specialty also have the opportunity to review the data and make their own medical judgements. The molecule’s heritage stands as proof that scientific curiosity and professional discipline are not opposites but complements.

DATA OVER DOGMA

In the modern era, the phrase “data over dogma” should guide all scientific discussions. Science moves via careful collection of data and patient outcomes. The peer review process employed by medical journals and proven by the test of time should not be replaced by anecdotal one-liners passing as scientific evidence. 

PDGF’s extensive bibliography demonstrates this principle. Its biological activity has been explored for decades, and each new dataset has refined, not replaced, our understanding of its mechanisms.10 The recombinant PDGF-BB used in ariessence® has been studied extensively over several decades, including long-term evaluations in clinical and laboratory settings. Across these studies and real-world experience, the medical usage of exogenous rhPDGF-BB has proven to be safe and effective.  Likewise, rhPDGF-BB has been applied topically onto intact and wounded skin; injected into intact skin intradermally, subcutaneously, intramuscularly, and intraperitonially; and injected intravenously, with these studies having been submitted to and reviewed by the FDA.

When speculation replaces science, public understanding and patient confidence suffer.

PROTECTING THE LEGACY OF DISCOVERY AND INNOVATIVE MEDICINE

The heritage of PDGF is a microcosm of modern regenerative science: a story defined by evidence, ethics, and endurance. Most importantly, millions of patients have benefited from the medical products based on pure PDGF. A future article in this publication will discuss the evidence more in-depth: where it is strongest, where it is limited, and what studies are ongoing or planned.

As clinicians and scientists, our role is not merely to apply the learnings of this heritage but to protect the principles that produced them. In an age when speed often outpaces scrutiny and facts, we must recommit to the values that guided PDGF’s evolution—independent medical judgement by expert clinicians, integrity, and collaboration.

False narratives about established science do not just misinform; they erode the foundation of trust upon which medicine depends. When anecdotes replace peer-reviewed published studies, or when public threats are made against our peers and their medical judgements and licenses are directly threatened, it risks destroying not only the trust that is essential for medicine to move forward but also the public’s trust in all dedicated health care professionals.

Disclosure: The author is founder and CEO of Lynch Regenerative Medicine.

  1. Heldin CH, Westermark B. Mechanism of action and in vivo role of platelet-derived growth factor. Physiol Rev. 1999;79(4):1283-1316.
  2. Hollinger JO, Hart CE, Hirsch SN, Lynch S, Friedlaender GE. Recombinant human platelet-derived growth factor: biology and clinical applications. J Bone Joint Surg Am. 2008;90 Suppl 1:48-54. doi: 10.2106/JBJS.G.01231.
  3. Kim MS, Song HJ, Lee SH, Lee CK. Comparative study of various growth factors and cytokines on type I collagen and hyaluronan production in human dermal fibroblasts. J Cosmet Dermatol. 2014;13(1):44-51. doi: 10.1111/jocd.12073.
  4. Juhl P, Bondesen S, et al. Dermal fibroblasts have different extracellular matrix profiles induced by TGF-β, PDGF and IL-6 in a model for skin fibrosis. Sci Rep. 2020;10(1):17300. doi: 10.1038/s41598-020-74179-6.
  5. Ozaki Y, Nishimura M, et al. Comprehensive analysis of chemotactic factors for bone marrow mesenchymal stem cells. Stem Cells Dev. 2007;16(1):119-29. doi: 10.1089/scd.2006.0032.
  6. Antoniades HN, Galanopoulos T, Neville-Golden J, Kiritsy CP, Lynch SE. Injury induces in vivo expression of platelet-derived growth factor (PDGF) and PDGF receptor mRNAs in skin epithelial cells and PDGF mRNA in connective tissue fibroblasts. Proc Natl Acad Sci U S A. 1991;88(2):565-9. doi: 10.1073/pnas.88.2.565.
  7. Solchaga LA, Hee CK, Roach S, Snel LB. Safety of recombinant human platelet-derived growth factor-BB in Augment(®) Bone Graft. J Tissue Eng. 2012;3(1):2041731412442668. doi: 10.1177/2041731412442668. Epub 2012 Apr 4.
  8. Young CS, Bradica G, et al. Preclinical Toxicology Studies of Recombinant Human Platelet-Derived Growth Factor-BB Either Alone or in Combination with Beta-Tricalcium Phosphate and Type I Collagen. J Tissue Eng. 2011;2010:246215. doi: 10.4061/2010/246215.
  9. Lynch SE, Marx RE, Nevins M, Wisner-Lynch L, eds. Tissue Engineering: Applications in Maxillofacial Surgery and Periodontics. 2nd ed. Quintessence Publishing Co; 2008:1-296.
  10. Lynch Regen Medicine. A Review of the Safety of Exogenously Applied rhPDGF-BB. 2025. Available at: https://www.lynchregen.com/research/
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