NCT07115082

Clinical Study on the Safety and Efficacy of Human Amniotic Mesenchymal Stem Cells in the Treatment of Premature Ovarian Insufficiency

A Randomized, Open-label, Parallel-controlled Clinical Study of Amniotic Mesenchymal Stem Cells in the Treatment of Premature Ovarian Insufficiency

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Yan Hongli · Academic / Other
• Sex: Female
• Age: 20 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

There is a high incidence of women suffering from Primary Ovarian Insufficiency (POI). So far, there was no treatment sufficient enough to cure POI. Cell therapy is a rapidly developing field and have shown immense promise in the treatment of ovarian dysfunction. In this study, the investigator will evaluate the safety of human Amniotic mesenchymal stem cells (hA-MSCs) therapy in women suffering from POI.

Detailed description

This clinical trial is designed to understand the safety and effectiveness of human amniotic membrane mesenchymal stem cells (hA-MSCs) in the treatment of primary ovarian insufficiency (POI). Human amniotic MSCs were infused back into the patients by intravenous injection. The trial was designed with two groups, 1) the control group by conventional hormone replacement therapy with oral Climen and 2) the stem cell treatment group by intravenous infusion of human amniotic membrane mesenchymal stem cells (hA-MSCs) combined with oral Climen hormone therapy. Patients were followed up every 2 weeks after the post-injection stem cells to observe their outcomes. The investigators focused on safety indicators, but also monitored hormone levels and signs of follicular growth to initially assess the effectiveness of the stem cells.

Conditions

• Premature Ovarian Insufficiency

Interventions

Type	Name	Description
DRUG	Climen 21 Tablets	Climen is commonly used clinically as a hormone replacement therapy and was administered to all patients in both the control and experimental groups in this project.
BIOLOGICAL	hA-MSCs	The patients who were part of the experimental group were administered oral Clomid medication in conjunction with a combined intravenous injection of human amniotic MSCs.

Timeline

• Start date: 2024-10-15
• Primary completion: 2025-12-01
• Completion: 2026-03-30
• First posted: 2025-08-11
• Last updated: 2025-08-11

Locations

1 site across 1 country: China