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

A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Perinatal Tissue Mesenchyme Stem Cells in the Treatment for Caesarean Section Scars

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.

Study Overview

• Status: Completed
• Conditions: Cicatrix
• Intervention / Treatment: Biological: Mesenchyme Stem Cells low-dose group; Biological: Mesenchyme Stem Cells high-dose group; Biological: Placebo

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Foshan, Guangdong, China, 528000
      • Maternal and Child Health Hospital of Foshan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 35 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Mesenchymal Stem Cells low-dose group; Target dose of 3 million Mesenchymal Stem Cells	Biological: Mesenchyme Stem Cells low-dose 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.
EXPERIMENTAL: Mesenchymal Stem Cells high-dose group; Target dose of 6 million Mesenchymal Stem Cells	Biological: Mesenchyme Stem Cells high-dose 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.
PLACEBO_COMPARATOR: Placebo; Placebo without Mesenchyme Stem Cells	Biological: Placebo; Participants will receive transdermal placebo without of Perinatal Tissue Mesenchyme Stem Cells in the gel once a day for continuous six days.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound healing status	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.	14 days post surgery
Erythema measured by reflectance	measured by reflectance	1st, 3rd, 6th month post treatment
Pigmentation measured by reflectance	measured by reflectance	1st, 3rd, 6th months post treatment
Scar Thickness and Uniformity	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.	1st, 3rd, 6th month post treatment
Change of scar area	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.	1st, 3rd, 6th month post treatment
Immunoglobulin concentrations in breast milk	Breast milk immunoglobulin (IgG, IgA, IgM) and the complement (C3, C4) were detected by transmission immune turbidity method using automatic biochemical analyzer.	1st, 3rd, 6th month post treatment
Subject's satisfaction	Subject's satisfaction of the treatment using a Satisfaction Scale as follows: None; Slight; Moderate; Good; Very Good.	6th month post treatment
Adverse events occurrence	Adverse events will be evaluated since the baseline visit until 6 months after the end of the treatment.	6 months

Collaborators and Investigators

• Sponsor: Maternal and Child Health Hospital of Foshan

Publications and helpful links

General Publications

• Fan D, Zeng M, Xia Q, Wu S, Ye S, Rao J, Lin D, Zhang H, Ma H, Han Z, Guo X, Liu Z. Efficacy and safety of umbilical cord mesenchymal stem cells in treatment of cesarean section skin scars: a randomized clinical trial. Stem Cell Res Ther. 2020 Jun 25;11(1):244. doi: 10.1186/s13287-020-01695-7.
• Fan D, Xia Q, Wu S, Ye S, Liu L, Wang W, Guo X, Liu Z. Mesenchymal stem cells in the treatment of Cesarean section skin scars: study protocol for a randomized, controlled trial. Trials. 2018 Mar 2;19(1):155. doi: 10.1186/s13063-018-2478-x.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2016
• Primary Completion (ACTUAL): September 1, 2018
• Study Completion (ACTUAL): March 1, 2019

Study Registration Dates

• First Submitted: May 10, 2016
• First Submitted That Met QC Criteria: May 11, 2016
• First Posted (ESTIMATE): May 13, 2016

Study Record Updates

• Last Update Posted (ACTUAL): May 7, 2019
• Last Update Submitted That Met QC Criteria: May 6, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Scars; Cesarean Section; Mesenchyme Stem Cells
• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix
• Other Study ID Numbers: MCHHFoshan-1602

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED