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

Phase 2

Withdrawn

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

• Registration Number: NCT04034615
• Lead Sponsor: Maternal and Child Health Hospital of Foshan

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.

Study Timeline

• Study First Submitted: 2019-07-24
• Study First Submitted QC: 2019-07-24
• Study First Posted: 2019-07-26
• Study Start: 2021-05-20
• Primary Completion: 2021-12-01
• Study Completion: 2022-06-01
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-19
• Last Update Posted: 2022-12-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Primary Outcome Measures

Name	Time	Method
Vancouver Scar Scale score	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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