NCT03816852

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

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

• Status: Suspended
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Sclnow Biotechnology Co., Ltd. · Industry
• Sex: Female
• Age: 19 Years – 40 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BIOLOGICAL	hucMSCs	Human umbilical cord mesenchymal stem cells were transplanted by intravenous infusion

Timeline

• Start date: 2018-10-01
• Primary completion: 2025-12-31
• Completion: 2026-06-30
• First posted: 2019-01-25
• Last updated: 2025-12-04

Locations

1 site across 1 country: China