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

A Phase I, Single-arm, Open Study of the Safety of Umbilical Cord Mesenchymal Stem Cell Local Intramuscular Injection for Treatment of Uterine Scars

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.

Study Overview

• Status: Withdrawn
• Conditions: Uterine Scar
• Intervention / Treatment: Other: Umbilical cord MSCs

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Foshan, Guangdong, China, 528000
      • Maternal and Child Health Hospital of Foshan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 31 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Umbilical cord MSCs Group; 1*10^7 Umbilical cord Mesenchymal Stem Cells (MSCs)	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety evaluation through vital signs, the results of clinical lab tests and adverse events	Safety evaluation through vital signs, the results of clinical lab tests and adverse events.	6 months post treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with uterine niche	The niche is defined as a triangular anechoic area at the presumed site of incision in the uterus by transvaginal utrasonography.	6 months post treatment
Change of uterine scar thickness	The scar thickness be measured using a transvaginal utrasonography	6 weeks, 3 and 6 months post treatment
Change of uterine scar area	The scar area will be measured using a transvaginal utrasonography	6 weeks, 3 and 6 months post treatment
Number of participants with endometritis	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.	6 months post treatment
Number of participants with wound infection	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.	6 months post treatment
Immunoglobulin concentrations in breast milk and serum	Breast milk and serum immunoglobulin (IgG, IgA, IgM) and the complement (C3, C4) are detected by transmission immune turbidity method using automatic biochemical analyzer.	6 weeks, 3 and 6 months post treatment
Adverse events occurrence	Adverse events will be evaluated since the baseline visit until 6 months after the end of the treatment.	6 months post treatment

Collaborators and Investigators

• Sponsor: Maternal and Child Health Hospital of Foshan

Study record dates

Study Major Dates

• Study Start (Anticipated): December 11, 2021
• Primary Completion (Anticipated): October 31, 2022
• Study Completion (Anticipated): May 30, 2023

Study Registration Dates

• First Submitted: June 7, 2017
• First Submitted That Met QC Criteria: June 7, 2017
• First Posted (Actual): June 8, 2017

Study Record Updates

• Last Update Posted (Actual): December 21, 2022
• Last Update Submitted That Met QC Criteria: December 19, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Mesenchymal Stem Cells; Cesarean Section; Uterine Scar
• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix
• Other Study ID Numbers: MCHHFoshan-1701

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No