SAN ANTONIO, Oct. 8, 2025 /PRNewswire/ — Sequence LifeScience Inc., a leader in allograft tissue processing, today announced a major milestone in its clinical development program: the first patient has been enrolled and treatment initiated in the company’s innovative multicenter, prospective, matched controls clinical trial evaluating the safety of its placental membrane grafts for the treatment of diabetic foot ulcers (DFUs).
The trial design is novel in that it employs a matched controls design using control patient data from the US Wound Registry to ensure robust, comparative data on treatment efficacy and safety.
This IRB approved trial design eliminates the need to enroll patients into a control non-treated group by utilizing matched controls with similar characteristics. This will reduce the overall number of patients needed to complete trials, allowing products that show positive clinical value to get to patients sooner.
This prospective, multi-center study marks the first time Sequence LifeScience’s proprietary placental membrane allografts, utilized in the treatment of acute and chronic wounds, have been evaluated in a prospective clinical trial for chronic DFUs. The study aims to assess the wound closure outcomes in patients with hard-to-heal diabetic foot ulcers, a condition that affects over 4 million people globally and remains one of the leading causes of lower limb amputation.
“Enrolling and grafting our first patient is a significant achievement not only for Sequence LifeScience, but for patients and clinicians who continue to face the devastating consequences of chronic, non-healing diabetic wounds,” said Dr Serena, Founder & CEO SerenaGroup, Inc. and lead investigator for the study. “These placental membrane grafts leverage the body’s own biological signals to stimulate healing in tissues that are resistant to conventional therapies.”
The investigational products are derived from human placental tissue and processed using Sequence LifeScience’s AlloKleen™ Process, which preserves the structural, and biochemical integrity of the extracellular matrix.
Clinical use of Sequence LifeScience’s matrix products has exhibited promising results since initially being released in late 2022.
“We know our products are safe and effective as we have distributed over 38,000 grafts over the last 3 years. This controlled study was designed to show the effectiveness of the products and to enable Medicare reimbursement for patients receiving these products. We are excited to show definitively, the positive outcomes patients get with these products and remain committed to addressing the urgent unmet need in diabetic wound care,” said Brian Kieser, President & CEO of Sequence LifeScience, Inc.
The trial is currently enrolling eligible participants at select clinical research sites across the U.S., with preliminary data expected mid-2026.
For more information about the clinical trial or participation opportunities, contact:
Madison Dunn
[email protected]
Media Contact:
Stephanie Lopez
[email protected]
210-545-3713
4590 Lockhill Selma Rd.
San Antonio, TX 78249
About Sequence LifeScience, Inc
Sequence LifeScience is a biomedical company focused on developing advanced regenerative therapies using ethically sourced human allograft tissues. With proprietary processing technologies and a commitment to clinical excellence, Sequence LifeScience is advancing a generation of biologics aimed at improving outcomes in wound care, surgical repair, and tissue regeneration.
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SOURCE Sequence Life Science
