Safety of Umbilical Cord Mesenchymal Stem Cell Local Intramuscular Injection for Treatment of Uterine Scars

NCT ID: NCT03181087

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WITHDRAWN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

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-11

Study Completion Date

2023-05-30

Brief Summary

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The purpose of this study is to evaluate the safety of umbilical cord mesenchymal stem cell local intramuscular injection for treatment of uterine scars by a prospective, single-center, open, and single-arm clinical trial.

Detailed Description

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Conditions

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Uterine Scar

Keywords

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Mesenchymal Stem Cells Cesarean Section Uterine Scar

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Umbilical cord MSCs Group

1\*10\^7 Umbilical cord Mesenchymal Stem Cells (MSCs)

Group Type EXPERIMENTAL

Umbilical cord MSCs

Intervention Type OTHER

Participants will receive direct local intramuscular injection of 1\*10\^7 MSCs (in 1ml of 0.9% saline) in the uterine incision.

Interventions

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Umbilical cord MSCs

Participants will receive direct local intramuscular injection of 1\*10\^7 MSCs (in 1ml of 0.9% saline) in the uterine incision.

Intervention Type OTHER

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 comply with study dosing and completed the entire course of the study
* Willing to give and sign an informed consent form and a photographic release form

Exclusion Criteria

* Fibroids
* Placenta previa
* Placenta abruption
* Multiple gestation
* Antepartum hemorrhage
* Preeclampsia/Eclampsia
* Hepatic or renal dysfunction
* Any systemic uncontrolled disease
* Inability to provide consent
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-1701

Identifier Type: -

Identifier Source: org_study_id