Results Indicate Overwhelming Success in Stem Cell Treatment of Diabetic Foot Ulcers

“This is great news for our patients with diabetic foot ulcers that are at such high risk of losing their legs”.

Osiris Therapeutics, Inc., has reported results from its multi-center, randomized, controlled clinical trial comparing the safety and effectiveness of Grafix® to standard of care in patients with chronic diabetic foot ulcers. The Grafix group met the pre-specified stopping rules for overwhelming efficacy as determined by the data monitoring committee during a planned interim analysis.

Background

Grafix is a human cellular repair matrix that provides a high-quality source of living mesenchymal stem cells (MSCs). It is a flexible, conforming membrane that is applied directly to acute and chronic wounds. It is a flexible, conforming membrane that provides a high quality source of living MSCs and growth factors directly to the site of the wound. Grafix is produced by BioSmartTM Intelligent Tissue Processing of human placental membrane. The manufacturing process maintains the integrity of the extracellular matrix, the viability of the neonatal MSCs, and the biologically active growth factors.

The trial, tagged “Protocol 302” is a single-blind, randomized, controlled multi-centered trial is evaluating the efficacy and safety of weekly applications of Grafix for the treatment of chronic diabetic foot ulcers. A total of 131 patients were enrolled at 19 leading wound care centers across the United States.

For the primary endpoint, 62% of patients receiving Grafix had complete wound closure compared to only 21% (p<0.0001) of patients who received conventional treatment for their wounds – a relative improvement of 191% and the largest ever reported from such a study. A total of 131 patients were enrolled with the interim analysis being conducted on the first 97 to complete the trial.

The trial also reached statistical significance in favor of Grafix on all top-line secondary endpoints, demonstrating faster wound closure and a reduction in the number of treatments needed to achieve wound closure. In the crossover phase of the trial, patients whose wounds failed to close after 12 weeks of standard of care had an 80% closure rate when switched to Grafix. Importantly, patients randomized to receive standard of care were 74% more likely to experience an adverse event than those receiving Grafix (p=0.008). As a result, the blinded phase of the trial is being discontinued immediately and all patients randomized to the control arm will be offered treatment with Grafix.

Physician comments

“These data are very compelling as we have not had a new cellular therapy for diabetic foot ulcers in over 10 years,” said Dr. Larry Lavery, Principal Investigator and Professor of Plastic Surgery, University of Texas Southwestern Medical Center. “Compared to other similarly designed studies, this trial demonstrates, by far, the largest relative improvement in complete wound closure. This is great news for our patients with diabetic foot ulcers that are at such high risk of losing their legs.”

Company comments 

“Today, Osiris has established a new standard in diabetic wound care and has demonstrated to the world the tremendous impact stem cell products can have in medicine,” said C. Randal Mills, Ph.D., Chief Executive Officer. “Diabetic foot ulcers afflict 25% of all diabetics and are responsible for more hospitalizations than any other diabetic complication. With 25 million diabetics in the United States, the cost to our health care system is enormous. Through this rigorous study we have shown that Grafix can heal more patients, in less time, and with fewer complications.”

“We know now that an unfortunate consequence of diabetes is the pathological change that occurs with the number and functionality of certain stem cell populations necessary for optimal wound repair,” said Michelle LeRoux Williams, Ph.D., Chief Scientific Officer. “With Grafix, we are able to help correct this problem by providing patients with a rich source of healthy, non-controversial stem cells contained within a biologic matrix for easy delivery in the out-patient setting.”

Source: Osiris Therapeutics, Inc., Business Wire