Back to resultsSafety of Umbilical Cord Mesenchymal Stem Cell Local Intramuscular Injection for Treatment of Uterine Scars
Primary Purpose
Uterine Scar
Status
Withdrawn
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Umbilical cord MSCs
Sponsored by
About this trial
This is an interventional treatment trial for Uterine Scar focused on measuring Mesenchymal Stem Cells, Cesarean Section, Uterine Scar
Eligibility Criteria
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
Sites / Locations
- Maternal and Child Health Hospital of Foshan
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Umbilical cord MSCs Group
Arm Description
1*10^7 Umbilical cord Mesenchymal Stem Cells (MSCs)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Change of uterine scar thickness
The scar thickness be measured using a transvaginal utrasonography
Change of uterine scar area
The scar area will be measured using a transvaginal utrasonography
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.
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.
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.
Adverse events occurrence
Adverse events will be evaluated since the baseline visit until 6 months after the end of the treatment.
Full Information
NCT ID
NCT03181087
First Posted
June 7, 2017
Last Updated
December 19, 2022
Sponsor
Maternal and Child Health Hospital of Foshan
1. Study Identification
Unique Protocol Identification Number
NCT03181087
Brief Title
Safety of Umbilical Cord Mesenchymal Stem Cell Local Intramuscular Injection for Treatment of Uterine Scars
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Withdrawn
Why Stopped
The pandemic resulted in no enrollments.
Study Start Date
December 11, 2021 (Anticipated)
Primary Completion Date
October 31, 2022 (Anticipated)
Study Completion Date
May 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maternal and Child Health Hospital of Foshan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Scar
Keywords
Mesenchymal Stem Cells, Cesarean Section, Uterine Scar
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Umbilical cord MSCs Group
Arm Type
Experimental
Arm Description
1*10^7 Umbilical cord Mesenchymal Stem Cells (MSCs)
Intervention Type
Other
Intervention Name(s)
Umbilical cord MSCs
Intervention Description
Participants will receive direct local intramuscular injection of 1*10^7 MSCs (in 1ml of 0.9% saline) in the uterine incision.
Primary Outcome Measure Information:
Title
Safety evaluation through vital signs, the results of clinical lab tests and adverse events
Description
Safety evaluation through vital signs, the results of clinical lab tests and adverse events.
Time Frame
6 months post treatment
Secondary Outcome Measure Information:
Title
Number of participants with uterine niche
Description
The niche is defined as a triangular anechoic area at the presumed site of incision in the uterus by transvaginal utrasonography.
Time Frame
6 months post treatment
Title
Change of uterine scar thickness
Description
The scar thickness be measured using a transvaginal utrasonography
Time Frame
6 weeks, 3 and 6 months post treatment
Title
Change of uterine scar area
Description
The scar area will be measured using a transvaginal utrasonography
Time Frame
6 weeks, 3 and 6 months post treatment
Title
Number of participants with endometritis
Description
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.
Time Frame
6 months post treatment
Title
Number of participants with wound infection
Description
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.
Time Frame
6 months post treatment
Title
Immunoglobulin concentrations in breast milk and serum
Description
Breast milk and serum immunoglobulin (IgG, IgA, IgM) and the complement (C3, C4) are detected by transmission immune turbidity method using automatic biochemical analyzer.
Time Frame
6 weeks, 3 and 6 months post treatment
Title
Adverse events occurrence
Description
Adverse events will be evaluated since the baseline visit until 6 months after the end of the treatment.
Time Frame
6 months post treatment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhengping Liu, MD
Organizational Affiliation
Maternal and Child Health Hospital of Foshan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maternal and Child Health Hospital of Foshan
City
Foshan
State/Province
Guangdong
ZIP/Postal Code
528000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Safety of Umbilical Cord Mesenchymal Stem Cell Local Intramuscular Injection for Treatment of Uterine Scars
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