Mesenchymal stem cells in the treatment of Cesarean section skin scars: study protocol for a randomized, controlled trial

Dazhi Fan, Qing Xia, Shuzhen Wu, Shaoxin Ye, Li Liu, Wen Wang, Xiaoling Guo, Zhengping Liu, Dazhi Fan, Qing Xia, Shuzhen Wu, Shaoxin Ye, Li Liu, Wen Wang, Xiaoling Guo, Zhengping Liu

Abstract

Background: 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.

Methods: 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 × 106 cells) or high-dose (transdermal hydrogel MSCs; 6 × 106 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.

Discussion: 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.

Trial registration: ClinicalTrials.gov, NCT02772289 . Registered on 10 May 2016.

Keywords: Cesarean section skin scars; Mesenchymal stem cells; Protocol; Randomized controlled trial.

Conflict of interest statement

Ethics approval and consent to participate

The protocol will be carried out in accordance with the Declaration of Helsinki, and has been approved by the ethics committee of the Southern Medical University Affiliated Maternal & Child Health Hospital of Foshan. It was registered with the Clinical Trial Registry (Consent for publication

Not applicable

Competing interests

The authors declare that they have no competing interests. The experimental product with MSCs and the placebo with hydrogel are provided without charge by Health-Biotech Pharmaceutical Co., Ltd., Beijing, China, which has had no role in designing the trial, and will not be involved in collection, management, analysis, interpretation of data, manuscript preparation and submission, or the final report and its publication, and does not have ultimate authority over any of these actions.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

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SPIRIT figure
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Trial schema

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