RecruitingPhase 1Phase 2NCT07115082

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

Sponsor

Yan Hongli

Enrollment

50 participants

Start Date

Oct 15, 2024

Study Type

INTERVENTIONAL

Conditions

Premature Ovarian Insufficiency

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.

Eligibility

Sex: FEMALEMin Age: 20 YearsMax Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Climen 21 Tablets and a biological treatment called hA-MSCs for people with premature ovarian insufficiency. The study is currently recruiting participants at 1 location. People eligible for this study include women aged 20 Years to 40 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGClimen 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.

BIOLOGICALhA-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.