Safety of Umbilical Cord Mesenchymal Stem Cell Local Intramuscular Injection for Treatment of Uterine Scars
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|ClinicalTrials.gov Identifier: NCT03181087|
Recruitment Status : Recruiting
First Posted : June 8, 2017
Last Update Posted : November 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Uterine Scar||Other: Umbilical cord MSCs||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Estimated Study Start Date :||November 11, 2017|
|Estimated Primary Completion Date :||January 31, 2018|
|Estimated Study Completion Date :||June 30, 2018|
Experimental: Umbilical cord MSCs Group
1*10^7 Umbilical cord Mesenchymal Stem Cells (MSCs)
Other: Umbilical cord MSCs
Participants will receive direct local intramuscular injection of 1*10^7 MSCs (in 1ml of 0.9% saline) in the uterine incision.
- Safety evaluation through vital signs, the results of clinical lab tests and adverse events [ Time Frame: 6 months post treatment ]Safety evaluation through vital signs, the results of clinical lab tests and adverse events.
- Number of participants with uterine niche [ Time Frame: 6 months post treatment ]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 [ Time Frame: 6 weeks, 3 and 6 months post treatment ]The scar thickness be measured using a transvaginal utrasonography
- Change of uterine scar area [ Time Frame: 6 weeks, 3 and 6 months post treatment ]The scar area will be measured using a transvaginal utrasonography
- Number of participants with endometritis [ Time Frame: 6 months post treatment ]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 [ Time Frame: 6 months post treatment ]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 [ Time Frame: 6 weeks, 3 and 6 months post treatment ]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 [ Time Frame: 6 months post treatment ]Adverse events will be evaluated since the baseline visit until 6 months after the end of the treatment.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03181087
|Contact: Zhengping Liu, MD||+ 86 757 firstname.lastname@example.org|
|Contact: Dazhi Fan, MD||+ 86 757 email@example.com|
|Maternal and Child Health Hospital of Foshan||Recruiting|
|Foshan, Guangdong, China, 528000|
|Contact: Deqin Jia, BD + 86 757 82969772 firstname.lastname@example.org|
|Sub-Investigator: Dazhi Fan, MD|
|Principal Investigator:||Zhengping Liu, MD||Maternal and Child Health Hospital of Foshan|