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

Study Overview
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Brief Summary
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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.

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

Conditions
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Uterine Scar

Intervention / Treatment
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* Other: Umbilical cord MSCs


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Umbilical cord MSCs Group<br>1*10^7 Umbilical cord Mesenchymal Stem Cells (MSCs) | Other: Umbilical cord MSCs<br>* Participants will receive direct local intramuscular injection of 1*10^7 MSCs (in 1ml of 0.9% saline) in the uterine incision.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mesenchymal Stem Cells, Cesarean Section, Uterine Scar