#USA #San Antonio #Clinical Trial #Diabetic Foot Ulcers #Sequence LifeScience

Sequence LifeScience Initiates Groundbreaking Clinical Trial

In a major advancement for diabetic wound care, Sequence LifeScience, Inc. has announced the enrollment of its first patient into a significant clinical trial aimed at treating diabetic foot ulcers (DFUs) using placental membrane grafts. This innovative study signifies a pivotal milestone in the company’s clinical development program and underscores an exciting leap forward in regenerative medicine.

The multicenter, prospective trial, which has received IRB approval, is characterized by its novel matched controls design. By using control data obtained from the US Wound Registry, this approach eliminates the necessity of enrolling a control group of non-treated patients. Instead, it allows researchers to utilize existing data from patients who share similar characteristics with those receiving treatment. This methodology accelerates the trial process and minimizes the number of participants needed to reach statistically relevant conclusions, fostering a quicker pathway for potentially life-changing therapies to reach patients in urgent need.

Diabetic foot ulcers are a critical health concern, affecting more than 4 million individuals worldwide and contributing significantly to the prevalence of lower limb amputations. The placental membrane grafts employed in this study are derived from ethically sourced human placental tissue and processed through the highly regarded AlloKleen™ Process developed by Sequence LifeScience. This sophisticated method preserves the unique structural and biological properties of the grafts, which are essential for encouraging healing in chronic wounds that traditional treatments often fail to address.

Dr. Serena, Founder and CEO of Serena Group, Inc., who is leading the study, emphasized the importance of this trial for both patients and healthcare providers. “Enrolling and grafting our first patient is not just a significant achievement for Sequence LifeScience; it represents hope for patients dealing with the severe impacts of chronic, non-healing diabetic wounds. These grafts utilize the body’s innate biological signals to promote healing in challenging cases.”

The clinical effectiveness of Sequence LifeScience’s grafts has already been demonstrated, with over 38,000 grafts distributed since their initial launch in late 2022. The goal of the current study is to substantiate these findings definitively, illustrating the effectiveness of the placental grafts while paving the way for Medicare reimbursement for eligible patients. Brian Kieser, President and CEO of Sequence LifeScience, expressed strong confidence in the trial’s potential outcomes, stating, “We are dedicated to addressing the critical and unmet needs in diabetic wound care. This controlled study was meticulously designed to demonstrate the efficacy of our products.”

As patient recruitment is currently underway at select clinical research sites across the United States, preliminary results are anticipated to be available by mid-2026. The trial not only offers promise for improved healing rates in diabetic foot ulcers but also represents an exciting development in the broader context of regenerative medicine and its applications in wound care.

For those interested in learning more about the clinical trial or exploring participation opportunities, further information can be obtained by contacting Madison Dunn. Media inquiries are welcomed through Stephanie Lopez, who can be reached via the provided contact details.

Sequence LifeScience is committed to the advancement of innovative regenerative therapies, utilizing ethically sourced human allograft tissue to drive improvements in wound care, surgical repair, and tissue regeneration. As the world looks for solutions to complex health challenges, trials like this one are essential in spearheading breakthroughs that can deliver significant health benefits to patients in need.