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

Uterine Scar Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03181087
• Other study ID #: MCHHFoshan-1701
• Status: Withdrawn
• Phase: Phase 1
• Start date: December 11, 2021
• Est. completion date: May 30, 2023

Study information

• Verified date: December 2022
• Source: Maternal and Child Health Hospital of Foshan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 30, 2023
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Cicatrix
• Uterine Scar

Intervention

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.

Locations

Country	Name	City	State
China	Maternal and Child Health Hospital of Foshan	Foshan	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Maternal and Child Health Hospital of Foshan

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Change of uterine scar thickness	The scar thickness be measured using a transvaginal utrasonography	6 weeks, 3 and 6 months post treatment
Secondary	Change of uterine scar area	The scar area will be measured using a transvaginal utrasonography	6 weeks, 3 and 6 months post treatment
Secondary	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
Secondary	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
Secondary	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
Secondary	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