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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Participants will receive direct local intramuscular injection of 1\*10\^7 MSCs (in 1ml of 0.9% saline) in the uterine incision.
Maternal and Child Health Hospital of Foshan
Foshan, Guangdong, China
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.
Time frame: 6 months post treatment
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.
Time frame: 6 months post treatment
Change of uterine scar thickness
The scar thickness be measured using a transvaginal utrasonography
Time frame: 6 weeks, 3 and 6 months post treatment
Change of uterine scar area
The scar area will be measured using a transvaginal utrasonography
Time frame: 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.
Time frame: 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.
Time frame: 6 months post treatment
Immunoglobulin concentrations in breast milk and serum
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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
Adverse events occurrence
Adverse events will be evaluated since the baseline visit until 6 months after the end of the treatment.
Time frame: 6 months post treatment