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

NCT02968459 | Withdrawn Phase 2 DMC

• 1 other identifier: MCHHFoshan-1603
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single center, randomized, double blind, placebo controlled study to evaluate the safety and efficacy of umbilical cord mesenchymal stem cell local intramuscular injection for treatment of caesarean section uterine scars.

Conditions

Uterine Scar

Keywords

Mesenchymal Stem Cells; Cesarean Section; Uterine Scar

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Change of uterine scar thickness

  6 weeks, 3 and 6 months post treatment

• Change of uterine scar area

  6 weeks, 3 and 6 months post treatment

• Number of participants with endometritis

  6 months post treatment

• Number of participants with wound infection

  6 months post treatment

• Immunoglobulin concentrations in breast milk and serum

  6 weeks, 3 and 6 months post treatment

Study Arms (2)

Umbilical cord MSCs Group

EXPERIMENTAL

1\*10\^7 Umbilical cord MSCs

Other: Umbilical cord MSCs

Placebo-Controlled Group

PLACEBO COMPARATOR

1ml of 0.9% saline

Other: 0.9% Saline

Interventions

Umbilical cord MSCs OTHER

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

Umbilical cord MSCs Group

0.9% Saline OTHER

Participants will receive direct local intramuscular injection 1ml of 0.9% saline in the uterine incision.

Placebo-Controlled Group

Eligibility Criteria

• Age: 21 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Maternal and Child Health Hospital of Foshan: lead

Study Sites (1)

Maternal and Child Health Hospital of Foshan

Foshan, Guangdong, 528000, China

Location

Related Publications (1)

• Fan D, Wu S, Ye S, Wang W, Guo X, Liu Z. Umbilical cord mesenchyme stem cell local intramuscular injection for treatment of uterine niche: Protocol for a prospective, randomized, double-blinded, placebo-controlled clinical trial. Medicine (Baltimore). 2017 Nov;96(44):e8480. doi: 10.1097/MD.0000000000008480.

  PMID: 29095305 BACKGROUND

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Zhengping Liu, MD

  Maternal and Child Health Hospital of Foshan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: November 14, 2016
• First Posted: November 18, 2016
• Study Start: October 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: April 1, 2022
• Last Updated: December 21, 2022

Record last verified: 2022-12

Locations

CN (1)