Status:
SUSPENDED
The Safety and Efficiency Study of Mesenchymal Stem Cell (19#iSCLife®-POI) in Premature Ovarian Insufficiency
Lead Sponsor:
Sclnow Biotechnology Co., Ltd.
Conditions:
Premature Ovarian Failure
Eligibility:
FEMALE
19-40 years
Phase:
PHASE2
Brief Summary
Evaluate the safety of human umbilical cord mesenchymal stem cells (hucMSCs) in POI treatment; Evaluate the effective hucMSCs in POI treatment. Compare different infusion mode, meanwhile compare with ...
Detailed Description
Premature ovarian insufficiency (POI) or premature ovarian failure (POF), is the loss of function of the ovaries before age 40, which has the features of menstrual disorder with high gonadotropic horm...
Eligibility Criteria
Inclusion
- Meet diagnostic criteria of European Society of Human Reproduction and Embryology
- No hormonotherapy and chinese traditional medicine within 3 months;
- Understand and sign informed consent.
Exclusion
- Patient with congenital adrenocortical hyperplasia;
- Patient with Cushing syndrome;
- Patient with Thyroid dysfunction;
- Patient with hyperprolactinemia;
- Patient with pituitary amenorrhea or hypothalamic amenorrhea;
- Patient with HIV, hepatitis;
- Gene defect (eg. Turner syndrome, fragile X syndrome)
- Serious drug allergy history;
- Suffering from thrombophlebitis, thromboembolism including venous thrombosis and arterial thrombosis;
- History of treatment of ovarian cysts or ovarian surgery
- With high tumor marker;
- Pregnant or lactating
- Receive other treatments that may affect the efficacy and safety of stem cells;
- Do not understand or without sign informed consent;
- The attending physician believes that it is not suitable for participating in this trial
Key Trial Info
Start Date :
October 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03816852
Start Date
October 1 2018
End Date
June 30 2026
Last Update
December 4 2025
Active Locations (1)
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1
Henan Provincial People's Hospital
Zhengzhou, Henan, China, 450003