Human (autologous) epidermis-derived cell sheet((Japan Tissue Engineering)

In Japan, the JACE^® cultured epidermal autograft (CEA) was approved and covered by public healthcare insurance for use in the treatment of giant congenital melanocytic nevus (GCMN) in 2016. We herein report the results of the application of JACE^® after curettage and Q-switched ruby laser therapy. The current patient was the first patient with GCMN to be treated with JACE^® since its approval. A 3-month-old girl had a hairy GCMN of 9.5 cm in diameter from her cheek to her temple on the left side of her face. We first performed curettage of the nevus on the temple and applied irradiation using a Q-switched ruby laser; however, erosion relapsed at 2 months after first surgery. After preparing JACE^®, we performed curettage a second time at 7 months with irradiation of a Q-switched ruby laser and the application of the CEA. The CEA took successfully and the wound was completely epithelized at 1 week after grafting. Re-pigmentation is an important issue that remains to be solved; however, overcoming this would allow for a deeper abrasion or more intense laser irradiation to be performed in cases in which CEA will be subsequently applied.

In the 1970s, Green et al. developed a method that involved culturing keratinocyte sheets and used for treatment of burns. Since then, the take rate of cultured epidermal autograft (CEA) onto fascia, granulation tissue, or allografts has been extensively reported, while that on an artificial dermis in a large case series is not. Moreover, the contribution of CEA to patient survival has not been analyzed in a multicenter study.

We conducted a 6-year multicenter surveillance on the application of the CEA "JACE(®") for treatment of burns >30% total body surface area (TBSA) across 118 Japanese hospitals. This surveillance included 216 patients and 718 graft sites for efficacy analysis. The CEA take rate at 4 weeks after grafting was evaluated, and safety was monitored until 52 weeks. In addition, the survival curve obtained in this study and the data obtained from the Tokyo Burn Unit Association (TBUA) were compared.

The mean CEA take rates at week 4 were 66% (sites) and 68% (patients), and the rate on the artificial dermis was 65% for 226 sites. CEA application combined with wide split-thickness auto or patch autograft increased the CEA take rate. On comparison with the data obtained from the TBUA, which included data on individuals with burns of the same severity, CEA application was found to contribute to patient survival until 7 weeks after burn.

We reported the take rate of CEA based on a 6-year multicenter surveillance. From our results, we found that the application of CEA is a useful treatment for the patients with extensive burns.