Clinical Study on the Safety and Effectiveness of Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Premature Ovarian Insufficiency
Trial Snapshot
- Phase
- Phase 2
- Status
- Suspended
- Sponsor
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Menstrual changes
Study Overview
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 hormone replacement therapy (HRT) withdrawal, so that assessing the stem cell therapy.
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 hormone and low estrogen. The morbidity of POI is about 0.1% among woman before 40 years, 10-28% among woman with primary amenorrhea, and 4-18% among woman with secondary amenorrhea. Recent years research shows different sources of stem cell could be used to POI, and with effective results.
Above all, this experiment designed to as a single center, random, and control experiment. treat POI patients wit human umbilical cord mesenchymal stem cells (MSCs). After regular follow-up and analysis, assessing the safety and effective of MSCs in POI treatment.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 19 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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
Arms & Interventions
Low dose group
Intravenous infusion with hucMSCs, 3*10^7 cells, 30ml
Intervention: hucMSCs (Biological)
High dose group
Intravenous infusion with hucMSCs, 9*10^7 cells, 30ml
Intervention: hucMSCs (Biological)
Medium dose group
Intravenous infusion with hucMSCs, 6*10^7 cells, 30ml
Intervention: hucMSCs (Biological)
Outcomes
Primary Outcomes
Menstrual changes
Time Frame: 270 days
Observe the change of patients with irregular menstrual cycle
Secondary Outcomes
- Kupperman score(270 days)
- Follicular development(270 days)
- hormone level(270 days)