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

Trial Summary

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.

What data supports the effectiveness of the drug RhPDGF-BB for wound healing?

Research shows that RhPDGF-BB, a protein that helps cells grow and move, can speed up wound healing. In studies, it helped wounds heal faster in both animals and humans, especially in cases like chronic pressure ulcers, where higher doses led to smaller wound sizes compared to a placebo. ^{1 2 3 4 5}

Is rhPDGF-BB safe for use in humans?

Research shows that rhPDGF-BB is generally safe for use in humans, with studies indicating it is biocompatible and has no systemic or local toxicity when used alone or with other substances, supporting its safe use in wound healing. ^{3 6 7 8 9}

How is the drug rhPDGF-BB unique in treating wound healing?

The drug rhPDGF-BB is unique because it is a bioactive protein that stimulates cell growth and tissue repair, promoting faster and more effective wound healing. It is specifically designed to enhance the formation of granulation tissue, which is crucial for healing, and has been shown to be safe and biocompatible in various studies. ^{1 3 6 7 10}

What is the purpose of this trial?

Skin cancers such as basal cell carcinoma (BCC), squamous cell carcinoma (SCC), and melanoma lesions that develop on the head and neck are treated by Mohs surgery or wide local excision to remove all tumor cells and preserve the normal tissue. These surgical techniques may result in large wounds requiring reconstructive surgery to restore function and aesthetics. Older, frail patients are particularly vulnerable to complications from these invasive procedures often leaving them to care for chronic wounds until a split-thickness skin graft can be placed. Recombinant human platelet-derived growth factor (rhPDGF) is a manufactured protein that signals through the PDGF receptor, PDGFRβ, to mediate inflammation, granulation, angiogenesis, and remodeling during wound healing and skin repair and is FDA-cleared for diabetic neuropathic ulcers and periodontal bone and soft tissue reconstructions. Preclinical and clinical data suggest that rhPDGF may be a viable therapeutic strategy to augment the reconstruction of these complex surgical wounds by accelerating healing and reducing the time-to-readiness for skin graft placement.

Research Team

Wesley Thayer, MD, PhD

Principal Investigator

Vanderbilt University Medical Center

Eligibility Criteria

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

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)

Treatment Details

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).

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

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

2. China pubmed.ncbi.nlm.nih.gov

[Experimental study on recombinant human platelet-derived growth factor gel in a diabetic rat model of cutaneous incisal wound healing]. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Preclinical promise of becaplermin (rhPDGF-BB) in wound healing. [2021]

4. China pubmed.ncbi.nlm.nih.gov

Recombinant human platelet-derived growth factor enhances repair of cutaneous full-thickness excision by increasing the phosphorylation of extracellular signal-regulated kinase in diabetic rat. [2009]

5. England pubmed.ncbi.nlm.nih.gov

Platelet-derived growth factor BB for the treatment of chronic pressure ulcers. [2022]

6. England 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. [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Simple, rapid, high-purity preparation of recombinant human platelet-derived growth factor-BB. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Recombinant Human Platelet-Derived Growth Factor: A Systematic Review of Clinical Findings in Oral Regenerative Procedures. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Recombinant human platelet-derived growth factor for refractory nondiabetic ulcers: a retrospective series. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Periodontal regeneration in humans using recombinant human platelet-derived growth factor-BB (rhPDGF-BB) and allogenic bone. [2022]