Two allograft products developed by Samaritan Biologics to be evaluated nationwide.
MEMPHIS, Tenn. (June 30, 2025) – Samaritan Biologics, a comprehensive manufacturer and supplier of human allografts, today announced the enrollment of its first participants in a randomized controlled clinical trial for multiple proprietary perinatal tissue allografts to treat non-healing diabetic foot ulcers. SerenaGroup is leading the study and is conducting it as a randomized controlled modified platform trial.
The trial will evaluate two unique perinatal tissue-derived allografts from Samaritan Biologics. The trial’s goal is to determine whether these allografts can heal chronic, non-healing diabetic foot ulcers more effectively than current standard wound care techniques. The trial design includes the enrollment of 170 patients in total.
“This innovative study represents a significant step forward in Samaritan Biologics’ commitment to finding effective solutions for patients suffering from chronic wounds, including, diabetic foot ulcers,” said David Szalay, Managing Partner and CEO of Samaritan Biologics.
The clinical trial will evaluate the efficacy of multiple perinatal tissue-derived allografts, also known as cellular, acellular and matrix-like products (CAMPs), with standard of care versus standard of care alone. The allografts are processed using Samaritan’s proprietary RETAIN Processing Technique, developed to minimize the loss of the natural perinatal tissue components throughout the processing episode.
- Complete™ AA is composed of two layers of amniotic membrane and is a sterile, single-use, dehydrated allograft.
- MOST™ is a four-layer dehydrated allograft that is also sterile and single use. The layers are comprised of amnion, intermediate layer, chorion and amnion.
The trial will take place in more than 15 research sites, including private clinics, across the United States, allowing an inclusive selection of participants from varying backgrounds and demographics.
“We are thrilled to launch this study with SerenaGroup, and we look forward to demonstrating the difference our products make in improving the quality of life for patients with DFUs,” said Jeremy Mercuri, Ph.D., Chief Scientific Officer of Samaritan.
About Samaritan Biologics
Samaritan Biologics, LLC is a woman and minority-owned business specializing in the development of human allografts. Samaritan is headquartered in Memphis, Tennessee, with an R&D facility located at the Clemson University Biomedical Engineering Innovation Campus (CUBEInC) in Greenville, South Carolina. It recently opened a state-of-the-art, 11,000-square-foot manufacturing facility located at Clemson’s ICAR campus. Since its founding in 2019, Samaritan has focused on “Helping, Healing, and Giving.” The organization achieves this mission by developing and distributing best-in-class perinatal tissue allografts for patients and providers, as well as by donating at least 10% of after-tax profits back to 501(c)(3) charities, including Breakthrough T1D (formerly JDRF). For more information, please visit SamaritanBiologics.com.
About SerenaGroup
SerenaGroup is a global leader in wound care clinical trials, specializing in testing and validating new technologies, treatments, and products that improve patient outcomes. The SerenaGroup team comprises experienced clinicians, researchers, and healthcare professionals who are passionate about making a difference in the lives of patients. With a focus on evidence-based research, the SerenaGroup works tirelessly to bridge the gap between clinical practice and research, better care standards and patient experiences.
Dr. Thomas Serena has published more than 200 papers and given more than 1,000 lectures worldwide. His well-decorated tenure includes past-President of the Association for the Advancement of Wound Care (AAWC) and the American Professional Wound Care Association, former board member of the Wound Healing Society, and also Vice-President of the American College of Hyperbaric Medicine.
