Rapid Healing of Venous Ulcers and Lack of Clinical Rejection With an Allogeneic Cultured Human Skin Equivalent

作者：Vincent Falanga · 发表于：Archives of Dermatology · 年份：1998 · DOI：10.1001/archderm.134.3.293 · 被引用次数：668 · 研究领域：Wound Healing and Treatments、Diagnosis and Treatment of Venous Diseases、Pressure Ulcer Prevention and Management

OBJECTIVE: To test the safety, efficacy, and immunological impact of a cultured allogeneic human skin equivalent (HSE) in the treatment of venous ulcers. DESIGN: Prospective, randomized study. SETTING: Multicenter 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 safety, complete (100%) ulcer healing, time to wound closure, wound recurrence, and immune response to the HSE. OUTCOME: The study was completed as planned in 293 randomized patients. RESULTS: Treatment with HSE was more effective than compression therapy in the percentage of patients healed by 6 months (63% vs 49%; P=.02, Fisher exact test, 2-tailed) and the median time to complete wound closure (61 days vs 181 days; P=.003, log-rank test). Treatment with HSE was superior to compression therapy in healing larger (> 1000 mm2; 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-specific immune responses were detected in vitro to bovine collagen or to alloantigens expressed on keratinocytes or fibroblasts. CONCLUSIONS: Treatment with HSE healed venous ulcers more rapidly and in more patients than compression therapy alone. There was no clinical or laboratory evidence of rejection or sensit...