Study Stopped
The pandemic resulted in no enrollments.
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
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Dec 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 7, 2017
CompletedFirst Posted
Study publicly available on registry
June 8, 2017
CompletedStudy Start
First participant enrolled
December 11, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2023
CompletedDecember 21, 2022
December 1, 2022
11 months
June 7, 2017
December 19, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
Number of participants with uterine niche
6 months post treatment
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
- +2 more secondary outcomes
Study Arms (1)
Umbilical cord MSCs Group
EXPERIMENTAL1\*10\^7 Umbilical cord Mesenchymal Stem Cells (MSCs)
Interventions
Participants will receive direct local intramuscular injection of 1\*10\^7 MSCs (in 1ml of 0.9% saline) in the uterine incision.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Maternal and Child Health Hospital of Foshan
Foshan, Guangdong, 528000, China
Study Officials
- PRINCIPAL INVESTIGATOR
Zhengping Liu, MD
Maternal and Child Health Hospital of Foshan
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
June 7, 2017
First Posted
June 8, 2017
Study Start
December 11, 2021
Primary Completion
October 31, 2022
Study Completion
May 30, 2023
Last Updated
December 21, 2022
Record last verified: 2022-12