Tuesday, 13 August 2013

Grafix® demonstrates efficacy in stem cell study for the treatment of Diabetic Foot Ulcers

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

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.

"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. 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." said C. Randal Mills, Ph.D., Chief Executive Officer.

What is Grafix ?
Grafix is a human cellular repair matrix containing living stem cells for acute and chronic wound repair. 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. For more info on Grafix please click here.

Diabetic foot ulcer is a major complication of diabetes mellitus, and probably the major component of the diabetic foot. It occurs in 15% of all patients with diabetes and precedes 84% of all lower leg amputations.

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