Foshan Institute of Fetal Medicine, Affiliated Foshan Maternity & Child Healthcare Hospital, Southern Medical University, 11 Renminxi Road, Foshan, 528000, Guangdong, China.
Department of Obstetrics, Affiliated Foshan Maternity & Child Healthcare Hospital, Southern Medical University, 11 Renminxi Road, Foshan, 528000, Guangdong, China.
Stem Cell Res Ther. 2020 Jun 25;11(1):244. doi: 10.1186/s13287-020-01695-7.
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.
Ninety primiparous singleton pregnant women undergoing elective cesarean section were randomly allocated to receive placebo, low-dose (3 × 10 cells), or high-dose (6 × 10 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).
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.
This randomized clinical trial showed that UC-MSCs did not demonstrate the effects of improvement of cesarean section skin scars.
ClinicalTrials.gov identifier, NCT02772289. Registered on 13 May 2016.
剖宫产术后病理性皮肤瘢痕会影响年轻产妇的美观和心理社会状况，在一定程度上使妇产科医生和皮肤科医生感到沮丧。脐带间充质干细胞（UC-MSCs）作为一类多能细胞，在人体组织中丰富存在，为其对皮肤瘢痕组织的作用提供了多种可能性。在此，我们进行了一项随机、双盲、安慰剂对照、三臂临床试验，旨在评估 UC-MSCs 治疗初产妇剖宫产术后皮肤瘢痕的疗效和安全性。
90 名初产妇行择期剖宫产术，随机分为接受安慰剂、低剂量（3×10 个细胞）或高剂量（6×10 个细胞）透皮水凝胶 UC-MSCs 治疗的三组，在皮肤切口表面给药。主要结局是产后第 6 个月评估的温哥华瘢痕量表（VSS）评估的剖宫产术后皮肤瘢痕。
所有参与者均按方案完成了主要结局的试验。所有参与者在第 6 个月随访时估计的 VSS 总分平均值为 5.52，安慰剂组为 6.43，低剂量组为 5.18，高剂量组为 4.71。组间 VSS 评分的平均值无显著差异。各组之间也没有发现其他预设的次要结局有显著差异。三组均未报告明显的副作用或不良反应。
这项随机临床试验表明，UC-MSCs 对改善剖宫产术后皮肤瘢痕没有效果。
ClinicalTrials.gov 标识符，NCT02772289。于 2016 年 5 月 13 日注册。
