Clinical Trial Tests Skin Cell Spray as Leg Ulcer Therapy

Human keratinocyte cells (USDA.gov)

A clinical trial by researchers at Healthpoint Biotherapeutics in Fort Worth, Texas found a spray-on skin cell therapy to be faster and more effective in healing venous leg ulcers than the standard care. The findings, with contributions from research colleagues at University of Miami, University of North Carolina, and Barry University, appear online in the journal The Lancet (paid subscription required).

The phase 2 trial — a small sample test of effectiveness and safety — studied Healthpoint’s treatment candidate HP802-247, a spray-on compound made from skin cells known as keratinocytes and fibroblasts suspended in a mixture of various proteins to help with blood clotting. The trial involved 228 patients with venous leg ulcers, shallow wounds that develop when the leg veins don’t return blood back toward the heart as they should, and according to Healthpoint, affect some 2.5 million Americans. The ulcers form when persistently high blood pressure in the veins of the legs damages the skin, and are often slow to heal.

The patients were adults being treated for venous leg ulcers at 28 medical centers in the U.S. and Canada. In the study, the patients were divided into five groups: four of the groups received varying doses of HP802-247 at different intervals, while a control group received a placebo. All patients who took part in the trial also had compression bandages applied to the wounds, the most common treatment currently available for leg ulcers.

Patients who received the HP802-247 spray treatment to the wound every seven or 14 days experienced faster healing and greater likelihood of wound closure than those in the control group. Depending on the dosage and interval, patients receiving the treatment had a greater likelihood of wound closure of up to 52 percent than the control group after 12 weeks, and a 16 percent greater reduction in wound area after 7 days. The treatments also accelerated wound closure by an average of 21 days compared to the control group.

The HP802-247 treatments were generally well tolerated, says Healthpoint, with the most frequently reported adverse events being skin ulcers, cellulitis, wound infection, and skin irritation.

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