title: A clinical trial designed to evaluate the safety and effectiveness of a thermosensitive hydrogel-type cultured epidermal allograft for deep second-degree burns.
abstract: 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 (6.7×10(6)/1.5mL), (2) medium-dose group (2×10(7)/1.5mL), and (3) high-dose group (6.0×10(7)/1.5mL). 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.
authors.affiliation: Department of Burn Surgery, Burn Center, Hangang Sacred Heart Hospital, Hallym University Medical Center, Seoul, Republic of Korea. Electronic address: pkgom@hallym.or.kr.
authors.forename: Haejun
authors.initials: H
authors.lastname: Yim
authors.affiliation: Department of Burn Surgery, Burn Center, Hangang Sacred Heart Hospital, Hallym University Medical Center, Seoul, Republic of Korea; Department of Surgery, College of Medicine, Kangwon National University, Chuncheon, Kangwon Do, Republic of Korea. Electronic address: yht0227@hanmail.net.
authors.forename: Hyeong-Tae
authors.initials: HT
authors.lastname: Yang
authors.affiliation: Department of Burn Surgery, Burn Center, Hangang Sacred Heart Hospital, Hallym University Medical Center, Seoul, Republic of Korea. Electronic address: maruchigs@hallym.or.kr.
authors.forename: Yong-Suk
authors.initials: YS
authors.lastname: Cho
authors.affiliation: Department of Burn Surgery, Burn Center, Hangang Sacred Heart Hospital, Hallym University Medical Center, Seoul, Republic of Korea. Electronic address: dohern@hallym.ac.kr.
authors.forename: Dohern
authors.initials: D
authors.lastname: Kim
authors.affiliation: Department of Burn Surgery, Burn Center, Hangang Sacred Heart Hospital, Hallym University Medical Center, Seoul, Republic of Korea. Electronic address: mcjemba@hanmail.net.
authors.forename: Jong-Hyun
authors.initials: JH
authors.lastname: Kim
authors.affiliation: Department of Burn Surgery, Burn Center, Hangang Sacred Heart Hospital, Hallym University Medical Center, Seoul, Republic of Korea. Electronic address: chun0414@hallym.ac.kr.
authors.forename: Wook
authors.initials: W
authors.lastname: Chun
authors.affiliation: Department of Burn Surgery, Burn Center, Hangang Sacred Heart Hospital, Hallym University Medical Center, Seoul, Republic of Korea. Electronic address: hammerj@naver.com.
authors.forename: Jun
authors.initials: J
authors.lastname: Hur
mesh_terms: D000328:Adult; D000368:Aged; D064591:Allografts; D002056:Burns / Q000628:therapy*; D018929:Cell Culture Techniques; D004817:Epidermis; D005260:Female; D006801:Humans; D020100:Hydrogels / Q000627:therapeutic use*; D015603:Keratinocytes / Q000637:transplantation*; D008297:Male; D008875:Middle Aged; D062326:Re-Epithelialization; D014184:Transplantation, Homologous / Q000379:methods*; D016896:Treatment Outcome; D014945:Wound Healing; D055815:Young Adult
chemical_list: D020100:Hydrogels
keywords: Cultured epidermal allograft; Deep second degree burn; Thermo-sensitive hydrogel