Clinical study with allogeneic cultured dermal substitutes for chronic leg ulcers

Clinical studies of the use of allogeneic cultured dermal substitutes (CDSs) have been conducted in 30 medical centers across Japan with the support of the Millennium Project of the Ministry of Health, Labor and Welfare. The CDS is prepared by plating cultured fibroblasts on a spongy matrix made from hyaluronic acid and atelo-collagen. The aim of the present clinical study was to evaluate an allogeneic CDS as cell therapy in which cytokines are released to promote wound healing.

The CDS was applied repeatedly at an interval of 5-7 days to 13 patients being treated with intractable chronic leg ulcers, using the CDS as a dermatological treatment. Intractable leg ulcers, whether venous or arterial, are difficult to heal because they occur as a secondary change of disease.

None of these patients had responded to conventional therapies such as topical or surgical methods, but 77% of the patients had an efficacy score of > 80 points for wound healing with allogeneic CDS. A high safety level was obtained: A, 84.6%; B and C, 7.7%; D, 0%. In 92% of the patients, the final assessment of wound healing was good or very good.

For promotion of wound healing, the present CDS is superior to existing topical agents and occlusive dressings.