031 Clinical Trials with Allogeneic Cultured Dermal Substitutes for the Treatment of Burns and Skin Ulcers (Regenerating Medical Millennium Project of the Ministry of Health, Labor and Welfare)

Aim: Multi-center clinical trials were performed using allogeneic cultured dermal substitutes (CDS) newly developed in the R & D Center for Artificial Skin of Kitasato University. Method: This study was designed to evaluate the efficacy of CDS for the treatment of burns in 5 cases and the treatment of skin ulcers in 4 cases. Complications with the skin ulcers were diabetes (1 case), varix (1 case), and collagen diseases (2 cases). The wound surface area was measured with picture analysis software during the wound healing process. Results: The clinical evaluation was made using a protocol that includes a standard for the development of new wound dressings. According to the comprehensive judgment, the results achieved were evaluated as excellent for 4 burn cases and good for one case. Regarding the skin ulcers, results were excellent in 3 cases and good for one case. No harmful complications were observed during this study. Conclusions: CDS were useful for burn and ulcer treatment but the wound surface must be checked rigorously for the occurrence of infection during the healing process.