The Grafix clinical trial for the treatment of chronic diabetic foot ulcers has been approved for presentation in Las Vegas on Friday, September 27, 2013, according to Osiris Therapeutics, Inc. (OSIR). OSIR is the leading stem cell company. Principal Investigator and Professor of Plastic Surgery at the University of Texas Southwestern Medical Center, Dr. Larry Lavery, will present data from the clinical trial on the safety and effectiveness of Grafix®. Lavery will discuss primary and secondary endpoints along with key safety information. Grafix is a flexible, cellular repair matrix of stem cells that is used to treat acute and chronic wounds. The flexible matrix supplies living mesenchymal stem cells (MSCs) along with growth factors. BioSmartTM Intelligent Tissue Processing was used to produce Grafix.
OSIR had reported in August 2013 that the Grafix clinical trial had achieved pre-specified stopping rules for effectiveness. OSIR reports that 62 percent of the patients had complete wound closure as opposed to 21 percent of patients who received standard treatment. Additionally, Grafix closed wounds faster and required fewer treatments than conventional treatment.
The Grafix® trial is referred to as Protocol 302 and is a single-blind, randomized, controlled multi-center trial determining the effectiveness and safety of weekly applications of Grafix as a therapy for chronic diabetic foot ulcers. Nineteen wound care centers across the U.S. were used to evaluate a total of 131 patients for up to 12 weeks. Patients (18 to 80 years) that had confirmed type 1 or 2 diabetes with chronic diabetic foot ulcers on the dorsal or plantar surface were randomized to Grafix or control dressings at a 1:1 ratio. To be included in the trial, patients had to have foot ulcers for at least 4 weeks before the trial and the ulcers had to be 1 to 15 cm2 in size. A patient was excluded if their ulcer reduced more than 30 percent during a one week screening period.
A primary endpoint was established for complete wound closure by 12 weeks by an investigator and were confirmed using an independent, blinded Wound Core Lab. The secondary endpoint included complete wound closure rates for patients that completed all scheduled therapies, time to wound closure, number of applications, percentage of patients that achieved at least 50 percent decrease in wound size by day 28 as well as number of re-occurrences. Patients in the control group who did not heal within 12 weeks were placed into a cross-over arm. These patients were treated for 12 weeks more with open-label therapy with Grafix and then evaluated.