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

Phase 1

Withdrawn

• Conditions: Uterine Scar
• Interventions: Other: Umbilical cord MSCs

• Registration Number: NCT03181087
• Lead Sponsor: Maternal and Child Health Hospital of Foshan

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2017-06-07
• Study First Submitted QC: 2017-06-07
• Study First Posted: 2017-06-08
• Study Start: 2021-12-11
• Primary Completion: 2022-10-31
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-19
• Last Update Posted: 2022-12-21
• Study Completion: 2023-05-30

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• Status: WITHDRAWN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 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Safety evaluation through vital signs, the results of clinical lab tests and adverse events	6 months post treatment	Safety evaluation through vital signs, the results of clinical lab tests and adverse events.

Secondary Outcome Measures

Name	Time	Method
Change of uterine scar thickness	6 weeks, 3 and 6 months post treatment	The scar thickness be measured using a transvaginal utrasonography
Change of uterine scar area	6 weeks, 3 and 6 months post treatment	The scar area will be measured using a transvaginal utrasonography
Number of participants with uterine niche	6 months post treatment	The niche is defined as a triangular anechoic area at the presumed site of incision in the uterus by transvaginal utrasonography.
Number of participants with wound infection	6 months post treatment	Wound infection is defined as the presence of either superficial or deep incisional surgical-site infection characterized by cellulitis or erythema and induration around the incision or purulent discharge from the incision site with or without fever and included necrotizing fasciitis.
Immunoglobulin concentrations in breast milk and serum	6 weeks, 3 and 6 months post treatment	Breast milk and serum immunoglobulin (IgG, IgA, IgM) and the complement (C3, C4) are detected by transmission immune turbidity method using automatic biochemical analyzer.
Adverse events occurrence	6 months post treatment	Adverse events will be evaluated since the baseline visit until 6 months after the end of the treatment.
Number of participants with endometritis	6 months post treatment	Endometritis is defined as the presence of at least two of the following signs with no other recognized cause: fever (temperature of at least 38℃), abdominal pain, uterine tenderness, or purulent drainage from the uterus.

Trial Locations

Locations (1)

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