The Long-term Effect of Perinatal Tissue Mesenchyme Stem Cells in the Treatment for Caesarean Section Scars

December 19, 2022 updated by: Zhengping Liu, MD, Maternal and Child Health Hospital of Foshan

A Phase II, Randomized, Placebo-Controlled Study of the Long-term Efficacy of Perinatal Tissue Mesenchyme Stem Cells in the Treatment for Caesarean Section Scars

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

This trial is a continuation of the investigators' previous clinical trial (NCT02772289). In the previous three-arm randomized clinical trial involving women with primiparous singleton pregnancies, the investigators found umbilical cord mesenchymal stem cells was not significantly different from placebo for the reduction of cesarean section skin scar and did not increase recognition of participants'satisfaction at the sixth month follow-up. Although there was no statistical difference, the trial study found that the total vancouver scar scale rating was lower with the dose increased.

Some studies have suggested that it usually took 18-24 months for a typical scar matures. In this trial, the investigators want to continue to investigate the efficacy of perinatal tissue mesenchyme stem cells treatment on the appearance of a caesarean scar as compared to a similar untreated scar at the three years follow-up.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 33 years (Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

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
Vancouver Scar Scale score
Time Frame: Three years post treatment
The investigators measured scar at three years post treatment using Vancouver Scar Scale (VSS). The VSS included vascularity (normal, pink, red, or purple), pigmentation (normal, hypopigmented, mixed, or hyperpigmented), height (flat, < 2 mm, 2-5 mm, or > 5 mm), and pliability (normal, supple, yielding, firm, ropes, or contracture). Each variable contained ranked subscales that could be summed to obtain a total score ranging from 0 to 14, with 0 representing normal skin and a higher score representing a more marked or abnormal scar. The Chinese version of the VSS has been shown to have good intraclass correlations and Cronbach's α measures. All scars will be assessed independently by two observers on the same day when the participants are lying in a supine position with the scar exposed in bright light. If the data varies, another researcher will be required to assess the scar at the same day and the results with the highest frequency will be recorded.
Three years post treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Erythema
Time Frame: Three years post treatment
measured by reflectance
Three years post treatment
Pigmentation
Time Frame: Three years post treatment
measured by reflectance
Three years post treatment
Scar Thickness and Uniformity
Time Frame: Three years 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.
Three years post treatment
Subject's satisfaction
Time Frame: Three years post treatment
Subject's satisfaction of the treatment using a Satisfaction Scale as follows: None; Slight; Moderate; Good; Very Good.
Three years post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maternal and Child Health Hospital of Foshan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2021

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

June 1, 2022

Study Registration Dates

First Submitted

July 24, 2019

First Submitted That Met QC Criteria

July 24, 2019

First Posted (Actual)

July 26, 2019

Study Record Updates

Last Update Posted (Actual)

December 21, 2022

Last Update Submitted That Met QC Criteria

December 19, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCHHFoshan-1902

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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