Clinical trial of allogeneic cultured dermal substitutes for intractable skin ulcers.

The effect of allogeneic cultured dermal substitute (CDS) on wound healing was evaluated in 9 intractable skin ulcers in 5 patients who had failed to improve despite conventional topical treatment with basic fibroblast growth factor (bFGF) for more than 2 months. In general, the topical application of bFGF is effective in facilitating wound healing. However, skin regeneration was very slow in the present 9 cases. In this study, to improve the condition of these wounds, allogeneic CDS was applied once a week for 2 months. The wound healing process was evaluated, focusing on the reduction ratio of wound size through the granulation tissue formation associated with epithelialization. In all 9 cases, the wound size was successfully decreased after the application of CDS, and ulcers were completely resurfaced in 2 cases. In all cases, except the 2 cases showing complete wound closure, the mean wound size decreased to 33.3% of the original size, i.e., a mean reduction ratio of 33.3%. The present results indicate that allogeneic CDS can promote wound healing of intractable skin ulcers that fail to improve despite treatment with bFGF.