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

Primary Purpose

Cicatrix

Status
Withdrawn
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Mesenchyme Stem Cells low-dose group
Mesenchyme Stem Cells high-dose group
Placebo
Sponsored by
Maternal and Child Health Hospital of Foshan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cicatrix focused on measuring Mesenchyme Stem Cells, Cesarean Section, Scars

Eligibility Criteria

21 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Maternal and Child Health Hospital of Foshan

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Mesenchymal Stem Cells low-dose group

Mesenchymal Stem Cells high-dose group

Placebo

Arm Description

Target dose of 3 million Mesenchymal Stem Cells

Target dose of 6 million Mesenchymal Stem Cells

Placebo without Mesenchyme Stem Cells

Outcomes

Primary Outcome Measures

Vancouver Scar Scale score
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.

Secondary Outcome Measures

Erythema
measured by reflectance
Pigmentation
measured by reflectance
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.
Subject's satisfaction
Subject's satisfaction of the treatment using a Satisfaction Scale as follows: None; Slight; Moderate; Good; Very Good.

Full Information

First Posted
July 24, 2019
Last Updated
December 19, 2022
Sponsor
Maternal and Child Health Hospital of Foshan
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1. Study Identification

Unique Protocol Identification Number
NCT04034615
Brief Title
The Long-term Effect of Perinatal Tissue Mesenchyme Stem Cells in the Treatment for Caesarean Section Scars
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Withdrawn
Why Stopped
The pandemic resulted in no enrollments。
Study Start Date
May 20, 2021 (Actual)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
June 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maternal and Child Health Hospital of Foshan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cicatrix
Keywords
Mesenchyme Stem Cells, Cesarean Section, Scars

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mesenchymal Stem Cells low-dose group
Arm Type
Experimental
Arm Description
Target dose of 3 million Mesenchymal Stem Cells
Arm Title
Mesenchymal Stem Cells high-dose group
Arm Type
Experimental
Arm Description
Target dose of 6 million Mesenchymal Stem Cells
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo without Mesenchyme Stem Cells
Intervention Type
Biological
Intervention Name(s)
Mesenchyme Stem Cells low-dose group
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Mesenchyme Stem Cells high-dose group
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Participants will receive transdermal placebo without of Perinatal Tissue Mesenchyme Stem Cells in the gel once a day for continuous six days.
Primary Outcome Measure Information:
Title
Vancouver Scar Scale score
Description
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.
Time Frame
Three years post treatment
Secondary Outcome Measure Information:
Title
Erythema
Description
measured by reflectance
Time Frame
Three years post treatment
Title
Pigmentation
Description
measured by reflectance
Time Frame
Three years post treatment
Title
Scar Thickness and Uniformity
Description
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.
Time Frame
Three years post treatment
Title
Subject's satisfaction
Description
Subject's satisfaction of the treatment using a Satisfaction Scale as follows: None; Slight; Moderate; Good; Very Good.
Time Frame
Three years post treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhengping Liu, MD
Organizational Affiliation
Maternal and Child Health Hospital of Foshan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maternal and Child Health Hospital of Foshan
City
Foshan
State/Province
Guangdong
ZIP/Postal Code
528000
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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