Frozen allogeneic human epidermal cultured sheets for the cure of complicated leg ulcers

BACKGROUND. Skin ulcers due to venous stasis or diabetes are common among t he elderly and are difficult to treat. Repeated applications of cell-based products have been reported to result in cure or improvement of leg ulcers of small size in a fraction of patients. OBJECTIVE. TO examine the effects of frozen human allogeneic epidermal cult ures for the treatment of acute and chronic ulcers. METHODS. We treated a series of 10 consecutive patients with leg ulcers of different etiology and duration with frozen human allogeneic epidermal cult ures stored frozen and thawed for 5-10 minutes at room temperature before a pplication. Three patients had ulcers with exposed Achilles or extensor ten don. The ulcers treated were as large as 160 cm(2) in area and of up to 20- years' duration. After preliminary preparation of the wounds by debridement to remove necrotic tissue and application of silver sulfadiazine to contro l infection, thawed cultures were applied biweekly from 2 to 15 times depen ding on the size and complexity of the ulcer. RESULTS. All ulcers healed, including those with tendon exposure. After the first few applications, granulation tissue formed in the ulcer bed and on exposed tendons, and epidermal healing took place through proliferation and migration of cells from the margins of the wound. The time required for co mplete healing ranged from 1 to 31 weeks after the first application. CONCLUSION. The use of frozen human allogeneic epidermal cultures is a safe and effective treatment for venous or diabetic ulcers, even those with ten don exposure. It seems possible that any leg ulcer will be amenable to succ essful treatment by this method.