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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03181087
|Contact: Zhengping Liu, MD||+ 86 757 email@example.com|
|Contact: Dazhi Fan, MD||+ 86 757 firstname.lastname@example.org|
|Maternal and Child Health Hospital of Foshan||Recruiting|
|Foshan, Guangdong, China, 528000|
|Contact: Deqin Jia, BD + 86 757 82969772 email@example.com|
|Sub-Investigator: Dazhi Fan, MD|
|Principal Investigator:||Zhengping Liu, MD||Maternal and Child Health Hospital of Foshan|