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
Verified date | December 2022 |
Source | Maternal and Child Health Hospital of Foshan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |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 |
Country | Name | City | State |
---|---|---|---|
China | Maternal and Child Health Hospital of Foshan | Foshan | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Maternal and Child Health Hospital of Foshan |
China,
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 |
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