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

Sponsor

Sclnow Biotechnology Co., Ltd. (Industry)

Overall Status

Suspended

CT.gov ID

NCT03816852

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Premature Ovarian Failure	Biological: hucMSCs	Phase 2

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

Anticipated Enrollment :

12 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 1, 2018

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: High dose group

Intravenous infusion with hucMSCs, 9*10^7 cells, 30ml

Biological: hucMSCs

Human umbilical cord mesenchymal stem cells were transplanted by intravenous infusion

Experimental: Medium dose group

Intravenous infusion with hucMSCs, 6*10^7 cells, 30ml

Biological: hucMSCs

Human umbilical cord mesenchymal stem cells were transplanted by intravenous infusion

Experimental: Low dose group

Intravenous infusion with hucMSCs, 3*10^7 cells, 30ml

Biological: hucMSCs

Human umbilical cord mesenchymal stem cells were transplanted by intravenous infusion

Outcome Measures

Primary Outcome Measures

Menstrual changes [270 days]
Observe the change of patients with irregular menstrual cycle

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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