The Safety and Efficiency Study of Mesenchymal Stem Cell (19#iSCLife®-POI) in Premature Ovarian Insufficiency

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Study on the Safety and Effectiveness of Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Premature Ovarian Insufficiency

Conditions
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Premature Ovarian Failure

Intervention / Treatment
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* Biological: hucMSCs


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High dose group<br>Intravenous infusion with hucMSCs, 9*10^7 cells, 30ml | Biological: hucMSCs<br>* Human umbilical cord mesenchymal stem cells were transplanted by intravenous infusion<br>|
| Experimental: Medium dose group<br>Intravenous infusion with hucMSCs, 6*10^7 cells, 30ml | Biological: hucMSCs<br>* Human umbilical cord mesenchymal stem cells were transplanted by intravenous infusion<br>|
| Experimental: Low dose group<br>Intravenous infusion with hucMSCs, 3*10^7 cells, 30ml | Biological: hucMSCs<br>* Human umbilical cord mesenchymal stem cells were transplanted by intravenous infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Menstrual changes | Observe the change of patients with irregular menstrual cycle | 270 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kupperman score | Mild: <14; moderate: 14-26; serious: >26 | 270 days | 
| hormone level | Test the level change of Follicle-Stimulating Hormone (FSH), estrogen (E2), and Anti Mullerian Hormone (AMH) | 270 days | 
| Follicular development | Observe the size of ovarian follicles in each cycle. | 270 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Premature Ovarian Failure, Premature Ovarian Insufficiency, mesenchymal stem cell