A clinical trial designed to evaluate the safety and effectiveness of a thermosensitive hydrogel-type cultured epidermal allograft for deep second-degree burns

This study is a phase 1 and 2 clinical trial for investigating the safety profile, effective treatment dose and effectiveness of the newly developed thermosensitive hydrogel-type cultured epidermal allograft. For phase 1, the keratinocytes were divided into 3 groups as follows, with 5 patients in each group: (1) low-dose group (6.7 x 10(6)/1.5 mL), (2) medium-dose group (2 x 10(7)/1.5 mL), and (3) high-dose group (6.0 x 10(7)/1.5 mL). The second phase of the trial proceeded with 10 cases after choosing the most effective dose based on the analysis of the first phase. When comparing re-epithelialization time, medium-and high-dose group showed significantly shorter re-epithelialization time than low-dose group (p = 0.003 and p = 0.002). A total of 15 cases, 5 cases selected from phase 1 and 10 cases test in phase 2 with the medium dose, were compared with the re-epithelialization period. The re-epithelialization period was 9.6 +/- 4.0 days in the test site and 12.4 +/- 4.8 days in the control site. In the test site, reepithelialization was 2.8 +/- 1.8 days faster than in the control site (p < 0.0001). There was no significant adverse reaction in our clinical trial. In conclusion, this new type of CEAllo accelerates wound healing time and shows the safety. (C) 2014 Elsevier Ltd and ISBI. All rights reserved.