Cell Therapy for Chronic Ulcers
A novel spray-applied treatment of allogeneic cells shows promise for persistent leg ulcers.
To test the safety and efficacy of a new treatment for persistent venous leg ulcers, investigators conducted a randomized, placebo-controlled, multicenter, manufacturer-supported trial of a novel cell therapy (HP802-247). This agent is a mixture of cryopreserved, allogeneic, growth-arrested fibroblasts and keratinocytes derived from neonatal foreskin; the cells are thawed and delivered to the ulcer surface in a fibrin spray.
The 227 patients, who had at least one persistent ulcer with a wound area of 2 to 12 square centimeters, were divided into five groups of 40 to 50 patients each. One group received vehicle alone and four experimental groups received one of two different concentrations of cells, delivered either every 7 or every 14 days. The primary endpoint was change in wound area during the 12-week treatment duration. The most effective treatment delivered the lowest dose of cells — 0.5 x 106 cells per mL applied every other week. Patients in this treatment arm showed a significant 16% mean decrease in wound surface area compared with the vehicle group.
Comment: Cell therapies are entering routine use in dermatology. For instance, an unrelated dermal injection therapy based on cultured autologous fibroblasts received FDA approval within the last 2 years for treatment of fine lines. This large, phase 2 trial of HP802-247 shows significant benefit for treatment of refractory venous ulcers, but further research is needed to determine extended safety and how often complete reepithelialization is achievable. If approved, practical considerations of cost and insurance coverage would likely affect availability.
Published in Journal Watch Dermatology November 21, 2012
Kirsner RS et al. Spray-applied cell therapy with human allogeneic fibroblasts and keratinocytes for the treatment of chronic venous leg ulcers: A phase 2, multicentre, double-blind, randomised, placebo-controlled trial. Lancet 2012 Sep 15; 380:977. (http://dx.doi.org/10.1016/S0140-6736(12)60644-8)
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