Fan Dazhi, Xia Qing, Wu Shuzhen, Ye Shaoxin, Liu Li, Wang Wen, Guo Xiaoling, Liu Zhengping
Department of Obstetrics, Southern Medical University Affiliated Maternal & Child Health Hospital of Foshan, 11 Renminxi Road, Foshan, Guangdong, 528000, China.
Foshan Institute of Fetal Medicine, Southern Medical University Affiliated Maternal & Child Health Hospital of Foshan, Foshan, Guangdong, 528000, China.
Trials. 2018 Mar 2;19(1):155. doi: 10.1186/s13063-018-2478-x.
Cesarean delivery has already become a very common method of delivery around the world, especially in low-income countries. Hypertrophic scars and wound infections have affected younger mothers and frustrated obstetricians for a long time. Mesenchymal stem cells (MSCs) have strong potential for self-renewal and differentiation to multilineage cells. Previous studies have demonstrated that MSCs are involved in enhancing diabetic wound healing. Therefore, this study is designed to investigate the safety and efficacy of using MSCs in the treatment of Cesarean section skin scars.
This trial is a prospective, randomized, double-blind, placebo-controlled, single-center trial with three parallel groups. Ninety eligible participants will be randomly allocated to placebo, low-dose (transdermal hydrogel MSCs; 3 × 10 cells) or high-dose (transdermal hydrogel MSCs; 6 × 10 cells) groups at a 1:1:1 allocation ratio according to a randomization list, once a day for six consecutive days. Study duration will last for 6 months, comprising a 1 week run-in period and 24 weeks of follow-up. The primary aim of this trial is to compare the difference in Vancouver Scar Scale rating among the three groups at the 6th month. Adverse events, including severe and slight signs or symptoms, will be documented in case report forms. The study will be conducted at the Department of Obstetric of Southern Medical University Affiliated Maternal & Child Health Hospital of Foshan.
This trial is the first investigation of the potential for therapeutic use of MSCs for the management of women's skin scar after Cesarean delivery. The results will give us an effective therapeutic strategy to combat Cesarean section skin scars, even with uterine scarring.
ClinicalTrials.gov, NCT02772289 . Registered on 10 May 2016.
剖宫产已经成为全球非常常见的分娩方式，尤其是在低收入国家。肥厚性瘢痕和伤口感染长期以来一直困扰着年轻母亲并让产科医生感到沮丧。间充质干细胞（MSCs）具有强大的自我更新和分化为多谱系细胞的潜力。先前的研究表明，间充质干细胞参与促进糖尿病伤口愈合。因此，本研究旨在探讨使用间充质干细胞治疗剖宫产皮肤瘢痕的安全性和有效性。
本试验是一项前瞻性、随机、双盲、安慰剂对照、单中心试验，有三个平行组。90名符合条件的参与者将根据随机列表按1:1:1的分配比例随机分配到安慰剂组、低剂量（经皮水凝胶间充质干细胞；3×10⁶细胞）组或高剂量（经皮水凝胶间充质干细胞；6×10⁶细胞）组，连续6天每天一次。研究持续时间为6个月，包括1周的导入期和24周的随访期。本试验的主要目的是比较三组在第6个月时温哥华瘢痕量表评分的差异。不良事件，包括严重和轻微的体征或症状，将记录在病例报告表中。该研究将在佛山市南方医科大学附属妇幼保健院产科进行。
本试验是首次研究间充质干细胞在治疗剖宫产术后女性皮肤瘢痕方面的治疗潜力。研究结果将为我们提供一种有效的治疗策略来对抗剖宫产皮肤瘢痕，甚至是子宫瘢痕。
ClinicalTrials.gov，NCT02772289。于2016年5月10日注册。
