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

Phase 2

Suspended

• Conditions: Premature Ovarian Failure
• Interventions: Biological: hucMSCs

• Registration Number: NCT03816852
• Lead Sponsor: Sclnow Biotechnology Co., Ltd.

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 Timeline

• Study Start: 2018-10-01
• Study First Submitted: 2019-01-17
• Study First Submitted QC: 2019-01-24
• Study First Posted: 2019-01-25
• Status Verified: 2024-04
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-04
• Primary Completion: 2025-12-31
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: Female
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Medium dose group	hucMSCs	Intravenous infusion with hucMSCs, 6\*10\^7 cells, 30ml
Low dose group	hucMSCs	Intravenous infusion with hucMSCs, 3\*10\^7 cells, 30ml
High dose group	hucMSCs	Intravenous infusion with hucMSCs, 9\*10\^7 cells, 30ml

Primary Outcome Measures

Name	Time	Method
Menstrual changes	270 days	Observe the change of patients with irregular menstrual cycle

Secondary Outcome Measures

Name	Time	Method
Follicular development	270 days	Observe the size of ovarian follicles in each cycle.
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)

Trial Locations

Locations (1)

Henan Provincial People's Hospital; 🇨🇳 Zhengzhou, Henan, China