Lynch Regenerative Medicine Completes Enrollment in Phase II Trial of rhPDGF-BB for Full-Thickness Head and Neck Wound Healing
核心洞察
Lynch Regenerative Medicine (搜索) announced completion of enrollment in an investigator-initiated, randomized, double-blind, controlled Phase II trial of rhPDGF-BB for complex head and neck surgical wounds.
The study enrolled 34 participants with full-thickness defects following skin cancer (搜索) excision, comparing an rhPDGF-BB-enhanced collagen wound matrix to a saline-treated control.
The trial evaluates safety and effectiveness endpoints including granulation tissue formation, wound closure, scar appearance, and patient-reported pain and quality of life over an eight-week period.
Lynch Regenerative Medicine (搜索), LLC (LRM), a commercial-stage biotech company advancing regenerative medicine, has announced the completion of enrollment in an investigator-initiated Phase II clinical trial evaluating its recombinant human pure platelet-derived growth factor-BB (rhPDGF-BB, or pure PDGF) as an adjunctive therapy to promote healing of complex surgical wounds following skin cancer (搜索) excision. The randomized, double-blind, controlled trial is sponsored by Vanderbilt Health (搜索) (VH) and funded by LRM.
The clinical trial is designed to investigate whether an rhPDGF-BB-enhanced wound matrix can accelerate healing in patients with full-thickness head and neck surgical defects that cannot be closed primarily with sutures, staples, or glue following Mohs micrographic surgery or wide local excision. These wounds can require prolonged healing before reconstruction can be completed, particularly among older adults and other medically vulnerable patients.
"For patients with complex wounds following skin cancer (搜索) excision, the time it takes to become ready for reconstruction is a debilitating part of the recovery process," said Dr. Samuel Lynch, Founder and Chief Executive Officer of Lynch Regenerative Medicine (搜索). "This study is asking an important clinical question: can pure PDGF accelerate healing of large head and neck surgical wounds and help move patients toward wound closure sooner and with less scarring? With enrollment complete, we are one step closer to understanding the potential of pure PDGF to enhance patient outcomes in this challenging setting."
Study Design and Endpoints
The Phase II study enrolled thirty-four (34) participants, including nine (9) with full-thickness scalp wounds and twenty-five (25) with wounds on their face or neck resulting from excision of skin cancer (搜索). The randomized-controlled, double-blinded trial compares an rhPDGF-BB-enhanced collagen wound matrix to standard of care, in this case a saline-treated collagen wound matrix.
The study evaluates multiple safety and effectiveness endpoints, including time to and rate of granulation tissue formation, time to and rate of wound closure, overall healing rate, scar appearance and aesthetics, and patient-reported changes in pain and quality of life, using blinded expert assessments and standardized wound imaging and quantitative digital analysis. Patients are followed over the study's eight-week assessment period, after which data will be analyzed. The study is registered on ClinicalTrials.gov under identifier NCT06634030.
Investigator Perspective
Wesley Thayer, MD, PhD, newly appointed Chief of Plastic Surgery at Virginia Commonwealth University Health System and principal investigator for this study, stated, "This study focuses on a unique growth factor – pure PDGF-BB – that has proven clinical benefits in other applications, combined with engineered tissue substitutes to help patients heal, in some cases without the need for extra surgery such as a skin flap or skin graft procedure and with less scaring."
Regulatory Status and Company Background
The use of rhPDGF-BB being evaluated in this study is investigational and has not been approved by the U.S. Food and Drug Administration for this indication. The study remains ongoing, and no conclusions regarding safety or effectiveness can be drawn until the study is completed and the data are analyzed. The study protocol, informed consent, and other study documents were reviewed and approved by the applicable institutional review board.
Lynch Regenerative Medicine (搜索), LLC is headquartered in Franklin, Tennessee, and was founded by regenerative medicine and PDGF pioneer Dr. Samuel Lynch. The company develops and commercializes recombinant growth factor products across therapeutic and cosmetic applications. Its therapeutic portfolio includes Regranex Gel (搜索), an FDA-approved prescription biologic for promoting the healing of chronic wounds, and GEM 21S (搜索), an FDA-approved combination product indicated for specified periodontally related defects. LRM also markets ariessence pure PDGF+, a cosmetic product intended to improve the appearance of skin.