RAPID HEALING OF VENOUS ULCERS AND LACK OF CLINICAL REJECTION WITH ANALLOGENEIC CULTURED HUMAN SKIN EQUIVALENT

Objective: To test the safety, efficacy, and immunological impact of a cultured allogeneic human skin equivalent (HSE) in the treatment of v enous ulcers. Design: Prospective, randomized study. Setting: Multicen ter study in the outpatient setting. Intervention: Each patient with a venous ulcer received either compression therapy alone or compression therapy and treatment with HSE. The patients were evaluated for HSE s afety, complete (100%) ulcer healing, time to wound closure, wound rec urrence, and immune response to the HSE. Outcome: The study was comple ted as planned in 293 randomized patients. Results: Treatment with HSE was more effective than compression therapy in the percentage of pati ents healed by 6 months (63% vs 49%; P=.02, Fisher exact test, 2-taile d) and the median time to complete wound closure (61 days vs 181 days; P=.003, log-rank test). Treatment with HSE was superior to compressio n therapy in healing larger (>1000 mm(2); P=.02) and deeper ulcers (P= .003) and ulcers of more than 6 months' duration (P=.001). Occurrence of adverse events was similar in both groups. No symptoms or signs of rejection occurred in response to treatment with HSE, and no HSE-speci fic immune responses were detected in vitro to bovine collagen or to a lloantigens expressed on keratinocytes or fibroblasts. Conclusions: Tr eatment with HSE healed venous ulcers more rapidly and in more patient s than compression therapy alone. There was no clinical or laboratory evidence of rejection or sensitization in response to HSE application. These data suggest that HSE represents a significant advance in the t reatment of venous ulcers, particularly those that are difficult to he al.