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The pandemic resulted in no enrollments.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Umbilical cord MSCs Group | Experimental | 1*10^7 Umbilical cord Mesenchymal Stem Cells (MSCs) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Umbilical cord MSCs | Other | Participants will receive direct local intramuscular injection of 1*10^7 MSCs (in 1ml of 0.9% saline) in the uterine incision. |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhengping Liu, MD | Maternal and Child Health Hospital of Foshan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maternal and Child Health Hospital of Foshan | Foshan | Guangdong | 528000 | China |
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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 |