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

Sclnow Biotechnology

Status and phase: Suspended; Phase 2

Conditions: Premature Ovarian Failure

Treatments: Biological: hucMSCs

Study type: Interventional

Funder types: Industry

Identifiers

NCT03816852

SCLnow-HNRM-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 estimated patients

Sex: Female

Ages: 19 to 40 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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12 participants in 3 patient groups

High dose group

Experimental group

Description:

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

Treatment:

Biological: hucMSCs

Medium dose group

Experimental group

Description:

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

Treatment:

Biological: hucMSCs

Low dose group

Experimental group

Description:

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

Treatment:

Biological: hucMSCs