Perinatal Tissue Mesenchyme Stem Cells in the Treatment for Caesarean Section Scars

Phase 2

Completed

• Conditions: Cicatrix
• Interventions: Biological: Placebo; Biological: Mesenchyme Stem Cells low-dose group; Biological: Mesenchyme Stem Cells high-dose group

• Registration Number: NCT02772289
• Lead Sponsor: Maternal and Child Health Hospital of Foshan

Brief Summary

The study is to investigate the efficacy and safety of perinatal tissue mesenchyme stem cells treatment on the appearance of a caesarean scar as compared to a similar untreated scar.

Detailed Description

Nowadays, cesarean is one of the most common surgical interventions and its prevalence has increased in most countries in the recent years. Delay in healing of cesarean wound and formation of visible scar are common symptoms of maternal morbidity after cesarean section. These complications affect mother's quality of life due to stress, anxiety, delay in mother's ability and health recovery, and also they are associated with additional cost as a result of the increased need for wide spectrum antibiotics and sometimes hospitalization and repeated repair of wound. Improve the final aspect of would and visible scars, have been a challenge for medicine. Mesenchymal stem cells (MSC) are a population of pluripotent stem cells that are self-renewing and capable of differentiating into canonical cells of the mesenchyme. Recently, stem cells have been applied to regenerative medicine, even for internal organs such as blood vessels, nerves, and heart.

The study is to investigate the efficacy and safety of perinatal tissue mesenchyme stem cells treatment on the appearance of a caesarean scar as compared to a similar untreated scar. This is a randomized, double-blind, placebo-controlled clinical trial designed to investigate the efficacy and safety of perinatal tissue mesenchyme stem cells (MSC) treatment on the appearance of a caesarean scar as compared to a similar untreated scar. A total of ninety (90) participants will be randomized (1:1:1) to receive MSC or placebo. All of participants will be undergoing delivery by lower segment caesarean section through a transverse abdominal incision, and there will be no clear indication for a particular surgical technique or material to be used. In low-dose MSC group, participants will receive transdermal one dose of 1\*10\^6 cells of Perinatal Tissue Mesenchyme Stem Cells in the gel once a day for continuous three days and then receive transdermal placebo without of Perinatal Tissue Mesenchyme Stem Cells in the gel once a day for continuous next three days; In high-dose MSC group, participants will receive transdermal one dose of 1\*10\^6 cells of Perinatal Tissue Mesenchyme Stem Cells in the gel once a day for continuous six days; And in placebo group, participants will receive transdermal placebo without of Perinatal Tissue Mesenchyme Stem Cells in the gel once a day for continuous six days. After randomization, baseline data, and transdermal treatment, participants will be followed up at 1 month, 3 months and 6 months. For the purpose of the endpoint analysis and safety evaluations, the investigators will utilize an "intention-to-treat" study population.

Study Timeline

• Study First Submitted: 2016-05-10
• Study First Submitted QC: 2016-05-11
• Study First Posted: 2016-05-13
• Study Start: 2016-11
• Primary Completion: 2018-09
• Study Completion: 2019-03
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-06
• Last Update Posted: 2019-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

• Primiparous women receiving cesarean delivery
• Ages between 21-35 years
• Gestation ages ≥ 37 weeks and < 42 weeks
• Willing to give and sign an informed consent form and a photographic release form
• Willing to comply with study dosing and complete the entire course of the study

Exclusion Criteria

• Any systemic uncontrolled disease
• Recent or current cancer
• History or presenting with a keloid formation
• Wounds or local disease in treatment area
• Planning any other cosmetic procedure to the study area during the study period
• Smoking

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo without Mesenchyme Stem Cells
Mesenchymal Stem Cells low-dose group	Mesenchyme Stem Cells low-dose group	Target dose of 3 million Mesenchymal Stem Cells
Mesenchymal Stem Cells high-dose group	Mesenchyme Stem Cells high-dose group	Target dose of 6 million Mesenchymal Stem Cells

Primary Outcome Measures

Name	Time	Method
Change of Vancouver Scar Scale (VSS)	1st, 3rd, 6th month post treatment	The investigators measured quartile grading scale at 1st, 3rd and 6th months of study and evaluated the change of the scale

Secondary Outcome Measures

Name	Time	Method
Wound healing status	14 days post surgery	Wound healing status was assessed using REEDA scale which is based on the amount of redness, edema, ecchymosis, discharge and the approximation of wound edges (each one scored between 0-3); the final score was the sum of the items scores. Lower score indicated better healing.
Erythema measured by reflectance	1st, 3rd, 6th month post treatment	measured by reflectance
Change of scar area	1st, 3rd, 6th month post treatment	A High Definition Ultrasound (US) device will be used to generate a high resolution image of the skin layers of the treated and non-treated scar in order to measure and compare changes in scar area.
Scar Thickness and Uniformity	1st, 3rd, 6th month post treatment	A High Definition Ultrasound (US) device will be used to generate a high resolution image of the skin layers of the treated and non-treated scar in order to measure and compare changes in scar thickness and uniformity.
Pigmentation measured by reflectance	1st, 3rd, 6th months post treatment	measured by reflectance
Subject's satisfaction	6th month post treatment	Subject's satisfaction of the treatment using a Satisfaction Scale as follows: None; Slight; Moderate; Good; Very Good.
Immunoglobulin concentrations in breast milk	1st, 3rd, 6th month post treatment	Breast milk immunoglobulin (IgG, IgA, IgM) and the complement (C3, C4) were detected by transmission immune turbidity method using automatic biochemical analyzer.
Adverse events occurrence	6 months	Adverse events will be evaluated since the baseline visit until 6 months after the end of the treatment.

Trial Locations

Locations (1)

Maternal and Child Health Hospital of Foshan; 🇨🇳 Foshan, Guangdong, China