RecruitingPhase 1Phase 2NCT07775391

Phase Ⅰ/Ⅱa Trial Evaluating Intravenous hUC-MSCs Injection for Safety, Tolerability and Efficacy in Patients With POI

Phase Ⅰ/Ⅱa Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of Intravenous Injection of Human Umbilical Cord Mesenchymal Stem Cells (hUC-MSCs) in Patients With Premature Ovarian Insufficiency (POI)

Sponsor

Shenzhen Wingor Biotechnology Co., Ltd.

Enrollment

59 participants

Start Date

Aug 3, 2026

Study Type

INTERVENTIONAL

Conditions

Premature Ovarian Insufficiency

Summary

A Phase I/IIa clinical study evaluating the safety, tolerability and efficacy of intravenously administered human umbilical cord mesenchymal stem cell (hUC-MSCs) injection in patients with premature ovarian insufficiency (POI). The primary objective of the Phase I dose-escalation stage is to assess the safety and tolerability of intravenous infusion of hUC-MSCs injection for the treatment of POI, and to determine the recommended phase II dose (RP2D) for the Phase IIa clinical trial. The primary objective of the Phase IIa dose-expansion stage is to evaluate the efficacy of intravenous infusion of hUC-MSCs injection in POI treatment, and to generate data to support pivotal/confirmatory clinical trials.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Placebo, a drug called hUC-MSCs Injection (Phase I), and others for people with premature ovarian insufficiency. The study is currently recruiting participants at 1 location.

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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