Clinical Study of Umbilical Cord Mesenchymal Stem Cells Combined With Collagen Scaffold in the Treatment of Thin Endometrium
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|ClinicalTrials.gov Identifier: NCT03724617|
Recruitment Status : Unknown
Verified October 2018 by Xiaona Lin, Sir Run Run Shaw Hospital.
Recruitment status was: Recruiting
First Posted : October 30, 2018
Last Update Posted : October 30, 2018
|Condition or disease||Intervention/treatment||Phase|
|Thin Endometrium Intrauterine Adhesion||Drug: umbilical cord mesenchymal stem cells combined with collagen scaffold||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Study of Stem Cells in the Treatment of Thin Endometrium|
|Actual Study Start Date :||October 29, 2018|
|Estimated Primary Completion Date :||June 30, 2020|
|Estimated Study Completion Date :||December 31, 2020|
|Experimental: stem cell therapy||
Drug: umbilical cord mesenchymal stem cells combined with collagen scaffold
3-7 days after the end of menstruation, we underwent hysteroscopic exploration and separation if there was intrauterine adhesions. Intraoperative endometrial biopsy, recording biopsy location, endometrial specimens sent to HE examination and immunohistochemistry (vwf detection of microvessel density). The umbilical cord mesenchymal stem cell combined with collagen scaffold was spread on the balloon scaffold and placed in the uterine cavity. 5 ml of saline was filled into the balloon, and B-ultrasound confirmed that the scaffold was attached to the uterine wall. The patient was hospitalized for 2 hours and the patient's vital signs were recorded.
- the change of endometrial thickness [ Time Frame: Change from Baseline endometrial thickness at 6 months ]B-ultrasound measures and compares the endometrial thickness of the luteal phase before and after administration.
- pregnancy rate [ Time Frame: pregnancy rate at 1 year ]pregnancy rate = (pregnancy / observations) × 100%
- live birth rate [ Time Frame: live birth rate at 1 year ]live birth rate = (live births / observations) × 100%
- abortion rate [ Time Frame: abortion rate at 1 year ]abortion rate = (number of abortions / observations) × 100%
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): NCT03724617
|Contact: Xiaona Lin, Doctorfirstname.lastname@example.org|
|Sir Run Run Shaw hopital,School of medicine,Zhejiang University||Recruiting|
|Contact: Xiaona LIN 13588706863|
|Principal Investigator: Xiaona LIN, Doctor|
|Study Chair:||Xiaona Lin||Sir Run Run Shaw Hospital|