RhPDGF-BB for Wound Healing

Overseen By Cyndi R Clark, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Wesley Thayer

Disqualifiers: Infection, Radiation therapy, Allergic reactions, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 17

Duration: 8 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called rhPDGF-BB (Recombinant Human Platelet-Derived Growth Factor-BB) to aid in healing large wounds after skin cancer removal from the head or neck. The goal is to accelerate healing and facilitate quicker skin graft placement. Participants will receive either rhPDGF-BB or a placebo treatment with saline. This trial suits individuals who have undergone surgery to remove skin cancer and have a large wound that cannot be closed with stitches. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are currently enrolled in another drug or device trial, you may not be eligible to participate.

Is there any evidence suggesting that rhPDGF-BB is likely to be safe for humans?

Previous studies have shown that recombinant human platelet-derived growth factor-BB (rhPDGF-BB) is safe for healing. Research indicates that rhPDGF-BB is well-tolerated and has successfully treated diabetic ulcers and repaired other tissues. Clinical data demonstrate that it aids in wound healing, with no serious side effects reported in these cases. Since the FDA has already approved rhPDGF-BB for other uses, this offers reassurance about its safety in humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for wound healing?

Researchers are excited about rhPDGF-BB for wound healing because it introduces a novel approach by using a recombinant human platelet-derived growth factor. This active ingredient promotes the growth of new blood vessels and tissue, which can accelerate the healing process more effectively than traditional treatments like standard wound dressings or saline solutions. Unlike conventional options that mainly focus on keeping the wound clean and moist, rhPDGF-BB actively stimulates cellular processes to enhance recovery, potentially leading to faster and more efficient healing for patients.

What evidence suggests that rhPDGF-BB might be an effective treatment for wound healing?

Research has shown that rhPDGF-BB, which participants in this trial may receive, aids in wound healing and tissue repair. In past studies, rhPDGF-BB sped up healing in chronic wounds, such as those in individuals with diabetes. It sends signals to cells to assist with inflammation, tissue growth, and blood vessel formation, all crucial for healing. Clinical tests demonstrated its safety and effectiveness in these contexts, suggesting it might also aid in healing surgical wounds from skin cancer treatments. This treatment could potentially reduce the time before skin grafts can be applied, offering a valuable option for patients with complex surgical wounds. ^{3 6 7 8 9}

Who Is on the Research Team?

Wesley Thayer, MD, PhD

Principal Investigator

Vanderbilt University Medical Center

Are You a Good Fit for This Trial?

This trial is for older patients who have had Mohs surgery or wide local excision on the head and neck due to skin cancers like BCC, SCC, or melanoma. It's aimed at those who need reconstructive surgery but are dealing with chronic wounds before they can receive a skin graft.

Inclusion Criteria

Willing and able to provide informed consent for study participation and compliance with study protocol

I am over 21 years old.

Stated willingness to comply with all study procedures and availability for the duration of the study

Exclusion Criteria

Medical conditions that would, in the opinion of the Investigator or treating provider, compromise the safety of the individual with study participation and/or the ability of the individual to follow study protocol

The device will not fit the contour of the base of the wound bed

Known allergic reactions to porcine tissue, porcine collagen, or yeast-derived products

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Procedure

Participants undergo the baseline procedure to place the wound matrix into the wound bed, followed by randomization

1 day

1 visit (in-person)

Treatment

Participants receive either rhPDGF-BB-enhanced wound matrix or saline matrix, with weekly follow-up visits for 8 weeks

8 weeks

8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of skin graft success and aesthetic outcomes

8 weeks

8 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• RhPDGF-BB

Trial Overview The study tests RhPDGF-BB, a protein that helps with wound healing by reducing inflammation and promoting tissue growth. Patients will be compared to see if this treatment speeds up healing versus using saline (a placebo).

How Is the Trial Designed?

Group I: rhPDGF-BB matrix Experimental Treatment 1 Intervention

Participants receive wound matrix saturated with rhPDGF-BB.

Group II: Saline matrix Placebo Group 1 Intervention

Participants receive wound matrix saturated with normal saline.

RhPDGF-BB is already approved in United States, European Union for the following indications:

Approved in United States as rhPDGF-BB for:

• Diabetic foot ulcers
• Periodontal bone regeneration
• Orthopedic bone regeneration

Approved in European Union as rhPDGF-BB for:

• Diabetic foot ulcers
• Periodontal bone regeneration

Who Is Running the Clinical Trial?

Wesley Thayer

Lead Sponsor

Trials

1

Recruited

40+

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

Lynch Regenerative Medicine, LLC

Collaborator

Trials

2

Recruited

50+

Published Research Related to This Trial

The study involved 9 adult patients with advanced periodontitis and demonstrated that using purified recombinant human platelet-derived growth factor BB (rhPDGF-BB) mixed with bone allograft led to significant periodontal regeneration, including new bone, periodontal ligament, and cementum in both interproximal intrabony defects and Class II furcation lesions.

There were no safety concerns during the study, and the treatment resulted in substantial clinical improvements, with an average clinical attachment level gain of 6.17 mm and a vertical probing depth reduction of 6.42 mm in interproximal defects, indicating effective wound healing and regeneration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Periodontal regeneration in humans using recombinant human platelet-derived growth factor-BB (rhPDGF-BB) and allogenic bone. Nevins, M., Camelo, M., Nevins, ML., et al.[2022]

Recombinant human platelet-derived growth factor-BB (rhPDGF) is safe for use in oral regenerative procedures, with no serious adverse effects reported in 63 studies involving a mean follow-up of 10.7 months.

rhPDGF shows significant clinical benefits when combined with bone allografts, xenografts, or alloplasts for treating periodontal defects and gingival recession, as well as for guided bone regeneration and alveolar ridge preservation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recombinant Human Platelet-Derived Growth Factor: A Systematic Review of Clinical Findings in Oral Regenerative Procedures. Tavelli, L., Ravidà, A., Barootchi, S., et al.[2021]

In a study involving 12 patients with 14 refractory chronic ulcers, 64% of the ulcers healed after treatment with topical rhPDGF gel 0.01%, with an average healing time of 26 weeks.

The treatment was found to be effective and well-tolerated, although 22% of the healed ulcers reopened during a 15-month follow-up, indicating the need for ongoing monitoring after healing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recombinant human platelet-derived growth factor for refractory nondiabetic ulcers: a retrospective series. Harrison-Balestra, C., Eaglstein, WH., Falabela, AF., et al.[2022]

Recombinant human platelet-derived growth factor (rhPDGF-BB) combined with bone graft materials can effectively regenerate periodontal tissue by promoting cellular migration and proliferation, leading to improved healing outcomes.

The use of rhPDGF-BB not only accelerates soft tissue healing at surgical sites but also allows for quicker prosthetic care and earlier resumption of plaque control by patients, enhancing overall recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using recombinant platelet-derived growth factor to facilitate wound healing. Rosen, PS.[2018]

Recombinant human platelet-derived growth factor-BB (rhPDGF-BB) has been shown to be biocompatible and safe, with no systemic or local toxicity observed in extensive testing, making it a promising option for enhancing wound healing.

The study evaluated the effects of rhPDGF-BB alone and in combination with beta-tricalcium phosphate or collagen, confirming its safety in various applications related to tissue repair and inflammation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preclinical Toxicology Studies of Recombinant Human Platelet-Derived Growth Factor-BB Either Alone or in Combination with Beta-Tricalcium Phosphate and Type I Collagen. Young, CS., Bradica, G., Hart, CE., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7961612/

Recombinant Human Platelet–Derived Growth Factor rhPDGF is a safe and effective approach for the treatment of intrabony and furcation periodontal defects and gingival recession.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0741521495702458

Clinical evaluation of recombinant human platelet Once-daily topical application of rhPDGF-BB is safe and effective in stimulating the healing of chronic, full-thickness, lower-extremity diabetic neurotrophic ...

3. journals.lww.com journals.lww.com/plasreconsurg/abstract/9900/_pure_recombinant_platelet_derived_growth_factor.2779.aspx

Pure Recombinant Platelet-Derived Growth Factor in Tissue... This summary of evidence supports the safety and efficacy of pure PDGF-BB therapeutics in wound healing and tissue repair, can help guide ...

4. link.springer.com link.springer.com/article/10.1007/s12663-024-02194-5

Recombinant Platelet-Derived Growth Factor-BB (rhPDGF ... This study shows that use of collagen graft augmented with rhPDGF-BB could be beneficial in oral cavity reconstruction following resection of small lesions.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06634030

Evaluating rhPDGF-BB-Enhanced Wound Matrix for Head ... This Phase II clinical trial will evaluate the potential efficacy of rhPDGF-BB-enhanced wound matrix versus wound matrix saturated with normal saline to augment ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3324841/

Safety of recombinant human platelet-derived growth factor ... This article discusses nonclinical and clinical data regarding the safety of recombinant human platelet-derived growth factor-BB as a component of the Augment® ...

7. lynchregen.com lynchregen.com/wp-content/uploads/2025/09/RPT-001v1.0-A-Review-of-the-Safety-of-Exogenously-Applied-rhPDGF-vFinal.pdf

A Review of the Safety of Exogenously Applied ... ABSTRACT: • Recombinant human platelet-derived growth factor-BB (rhPDGF-BB) has been extensively studied for safety and efficacy in tissue repair and ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/22511993/

Safety of recombinant human platelet-derived growth factor ... The safety data presented provide evidence that recombinant human platelet-derived growth factor-BB is a safe therapeutic when used in combination products as a ...

9. sigmaaldrich.com sigmaaldrich.com/JP/en/product/sigma/p4306?srsltid=AfmBOor3fjR9iexFbkFRRvXvQPm5aPXpUOnRAG2cW2L9fkOXRHP78W_w

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