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

NCT ID: NCT04034615

Last Updated: 2022-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-20

Study Completion Date

2022-06-01

Brief Summary

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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

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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.

Conditions

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Cicatrix

Keywords

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Mesenchyme Stem Cells Cesarean Section Scars

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Mesenchymal Stem Cells low-dose group

Target dose of 3 million Mesenchymal Stem Cells

Group Type EXPERIMENTAL

Mesenchyme Stem Cells low-dose group

Intervention Type BIOLOGICAL

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.

Mesenchymal Stem Cells high-dose group

Target dose of 6 million Mesenchymal Stem Cells

Group Type EXPERIMENTAL

Mesenchyme Stem Cells high-dose group

Intervention Type BIOLOGICAL

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

Placebo without Mesenchyme Stem Cells

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Participants will receive transdermal placebo without of Perinatal Tissue Mesenchyme Stem Cells in the gel once a day for continuous six days.

Interventions

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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.

Intervention Type 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.

Intervention Type BIOLOGICAL

Placebo

Participants will receive transdermal placebo without of Perinatal Tissue Mesenchyme Stem Cells in the gel once a day for continuous six days.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Maternal and Child Health Hospital of Foshan

OTHER

Sponsor Role lead

Responsible Party

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Zhengping Liu, MD

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhengping Liu, MD

Role: PRINCIPAL_INVESTIGATOR

Maternal and Child Health Hospital of Foshan

Locations

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Maternal and Child Health Hospital of Foshan

Foshan, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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MCHHFoshan-1902

Identifier Type: -

Identifier Source: org_study_id