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

Citation

Fan, D and Qing, X and Wu, S and Ye, S and Liu, L and Wang, W and Guo, X and Liu, Z, Mesenchymal stem cells in the treatment of Cesarean section skin scars: Study protocol for a randomized, controlled trial, Trials, 19, (1) Article 155. ISSN 1745-6215 (2018) [Contribution to Refereed Journal]


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Copyright 2018 The Authors Licensed under Creative Commons Attribution 4.0 International (CC BY 4.0) https://creativecommons.org/licenses/by/4.0/

DOI: doi:10.1186/s13063-018-2478-x

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.

Item Details

Item Type:Contribution to Refereed Journal
Keywords:mesenchymal stem cells, cesarean section skin scars, randomized controlled trial, protocol
Research Division:Biomedical and Clinical Sciences
Research Group:Reproductive medicine
Research Field:Obstetrics and gynaecology
Objective Division:Health
Objective Group:Clinical health
Objective Field:Clinical health not elsewhere classified
UTAS Author:Qing, X (Miss Qing Xia)
ID Code:128628
Year Published:2018
Web of Science® Times Cited:5
Deposited By:Menzies Institute for Medical Research
Deposited On:2018-10-04
Last Modified:2019-12-23
Downloads:42 View Download Statistics

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