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 × 106/1.5 mL), (2) medium-dose group (2 × 107/1.5 mL), and (3) high-dose group (6.0 × 107/1.5 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, re-epithelialization 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.