BioStem Completes Enrollment in Trial of BioRetain Amnion Chorion for Diabetic Foot Ulcers

June 30, 2025—BioStem Technologies, Inc., a developer of placental-derived products for wound care, recently announced that patient enrollment has been completed in the company’s clinical trial evaluating its BioRetain-processed amnion chorion (BR-AC) versus standard of care for patients with nonhealing diabetic foot ulcers (DFUs).

According to the company, the BR-AC-DFU-101 study is a multicenter, randomized, controlled trial that was initiated in Q4 2024 at 11 sites across the United States to evaluate at least 60 patients with nonhealing DFUs.

BioStem stated that it recently completed enrollment of 71 patients in the study, with topline data expected to be reported in Q4 2025.

The study’s primary objective is to determine whether DFUs treated with standard care plus BR-AC achieve a higher probability of complete wound closure in a 12-week period compared to standard of care alone, noted the company.

Secondary outcome measures include comparing treatment group differences in proportions of wounds achieving complete wound closure based on time in days; comparing treatment group differences in wound area and volume; and assessing total number of applications of BR-AC required to achieve complete wound closure.

As explained in the press release, BioStem allografts are processed using the company’s BioRetain method, which retains the tissue’s native properties while maintaining the structure and matrix found in fresh perinatal tissue. The gentle, minimally invasive, six-step BioRetain process preserves the natural integrity of the amniotic tissue components critical to wound treatment, stated the company.