Abstract
BackgroundCesarean 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.MethodsThis 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.DiscussionThis 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 registrationClinicalTrials.gov, NCT02772289. Registered on 10 May 2016.
Highlights
Cesarean delivery has already become a very common method of delivery around the world, especially in low-income countries
Mesenchymal stem cells have a strong potential for selfrenewal and differentiation to multilineage cells
After 12 weeks, compared with control participants, the treatment participants had significant improvement in reduction in ulcer size. These results indicated that autologous implantation of bone marrow-derived Mesenchymal stem cells (MSCs) in nonhealing ulcers accelerated the healing process
Summary
Cesarean delivery has already become a very common method of delivery around the world, especially in low-income countries. Cesarean delivery has already become a very common method of delivery around the world, especially in low-income countries [1]. It requires a variety of cells to collaborate, such as resident cells of the skin, hematopoietic cells, and immune cells [5] Fan et al Trials (2018) 19:155 macrophage polarization, abnormal keratinocyte and fibroblast migration, proliferation, differentiation and apoptosis, impaired recruitment of mesenchymal stem cells (MSCs) and endothelial progenitor cells, and decreased vascularization may contribute to an abnormal wound healing process [6,7,8]. It is reported that enhanced and prolonged expression of tumor necrosis factor-alpha contributes to abnormal wound healing processes [9, 10]
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