Treatment of venous leg ulcers with cryopreserved cultured allogeneic keratinocytes: a prospective open controlled study.

Twenty-seven patients with chronic venous leg ulcers were assigned to two treatment groups. Fifteen were treated with cryopreserved cultured allogeneic keratinocyte sheets and compression bandages and 12 with compression only. The observation time was 8 weeks and the keratinocyte grafting procedure was performed once weekly. The mean reduction of the initial wound area was 35% in the treatment group and 14% in the control group. This difference was not significant. The poor effect on wound healing given by the cryopreserved allogeneic keratinocyte sheets contrasts with our earlier experience using fresh keratinocyte sheets. We believe that this is due to a weakened condition of the cryostored cells, as we have shown a loss in protein synthesis capacity of at least 50%.