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

NCT ID: NCT03816852

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2026-06-30

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.

Conditions

Premature Ovarian Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

High dose group

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

Group Type: EXPERIMENTAL

hucMSCs

Intervention Type: BIOLOGICAL

Human umbilical cord mesenchymal stem cells were transplanted by intravenous infusion

Medium dose group

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

Group Type: EXPERIMENTAL

hucMSCs

Intervention Type: BIOLOGICAL

Human umbilical cord mesenchymal stem cells were transplanted by intravenous infusion

Low dose group

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

Group Type: EXPERIMENTAL

hucMSCs

Intervention Type: BIOLOGICAL

Human umbilical cord mesenchymal stem cells were transplanted by intravenous infusion

Interventions

hucMSCs

Human umbilical cord mesenchymal stem cells were transplanted by intravenous infusion

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Sclnow Biotechnology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guangzhi Liu, Dr

Role: STUDY_DIRECTOR

Henan Provincial People's Hospital

Locations

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Countries

China

Other Identifiers

SCLnow-HNRM-01

Identifier Type: -

Identifier Source: org_study_id