A recent Phase II clinical trial of a wound healing stem cell gel found that the product promoted healing in 73% of patients with diabetic foot ulcers, compared to 46% treated with a placebo.

The gel, DSC127, is an analog of a naturally occurring peptide, Angiotensin. It has been shown to increase keratinocyte proliferation, increase extracellular matrix production, and increase vascularization.

Patients participating in the double-blind trial received treatment with either a stonger dose of DSC127 (.03%), a weaker dose (.01%), or a placebo. According to the results, compiled by the manufacturer Derma Sciences Inc, DSC127’s favorable results were more pronounced at 24 weeks of use than at 12 weeks, when compared with the placebo.

Additionally, no wounds treated with the stronger DSC127 topical had increased in size by the end of the 24-week study, whereas some wounds treated with placebo had increased in size by the end of the 24-week period.

“The continuation of a widening gap between 0.03% DSC127 and placebo out to 24 weeks is both promising and intriguing," said David Armstrong, DPM, MD, PhD, professor of surgery, director of the Southern Arizona Limb Salvage Alliance at the University of Arizona, the study’s lead investigator. "This type of response tracks well with the proposed method of action, interacting with receptors that are up-regulated at the time of injury, and helping to set those otherwise non-healing wounds on a trajectory towards healing.”

This summer, Derma Sciences is requesting an end-of-Phase II meeting with the FDA to discuss trial results. The company will also continue its development plan to commercialization and begin a Phase III trial in the first half of 2012.

[Source: Derma Sciences Inc]