Efficacy and safety of umbilical cord mesenchymal stem cells in treatment of cesarean section skin scars: a randomized clinical trial

Fan, Dazhi; Zeng, Meng; Xia, Qing; Wu, Shuzhen; Ye, Shaoxin; Rao, Jiaming; Lin, Dongxin; Zhang, Huishan; Ma, Huiting; Han, Zhongchao; Guo, Xiaoling; Liu, Zhengping

BACKGROUND: Pathological skin scars, caused by cesarean section, affected younger mothers esthetically and psychosocially and to some extent frustrated obstetricians and dermatologists. Umbilical cord mesenchymal stem cells (UC-MSCs), as a population of multipotent cells, are abundant in human tissues, providing several possibilities for their effects on skin scar tissues. Herein, we performed a randomized, double-blind, placebo-controlled, three-arm clinical trial, aiming to assess the efficacy and safety of UC-MSCs in the treatment of cesarean section skin scars among primiparous singleton pregnant women. METHODS: Ninety primiparous singleton pregnant women undergoing elective cesarean section were randomly allocated to receive placebo, low-dose (3 × 10(6) cells), or high-dose (6 × 10(6) cells) transdermal hydrogel UC-MSCs on the surface of the skin incision. The primary outcome was cesarean section skin scars followed after the sixth month, assessed by the Vancouver Scar Scale (VSS). RESULTS: All the participants completed their trial of the primary outcome according to the protocol. The mean score of estimated total VSS was 5.52 in all participants at the sixth-month follow-up, with 6.43 in the placebo group, 5.18 in the low-dose group, and 4.71 in the high-dose group, respectively. No significant difference was found between-group in the mean scores for VSS at the sixth month. Additional prespecified secondary outcomes were not found with significant differences among groups either. No obvious side effects or adverse effects were reported in any of the three arms. CONCLUSION: This randomized clinical trial showed that UC-MSCs did not demonstrate the effects of improvement of cesarean section skin scars. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT02772289. Registered on 13 May 2016.