Evaluating Safety, Tolerability, and Efficacy of Intravenous Human Umbilical Cord Mesenchymal Stem Cell Injection in Women with Premature Ovarian Insufficiency

What This Trial Is About

Researchers are investigating the safety, tolerability, and effectiveness of intravenous human umbilical cord mesenchymal stem cell hUC-MSCs injections in women with premature ovarian insufficiency POI, a condition causing ovarian dysfunction before age 40. This Phase IIIa clinical trial includes a dose-escalation phase to assess safety and find the recommended dose, followed by a dose-expansion phase to evaluate treatment effects and support future confirmatory trials. POI is characterized by menstrual irregularities and hormonal imbalances, and current hormone replacement therapies carry risks such as breast cancer and heart disease. Participants will receive intravenous infusions of hUC-MSCs a single dose during Phase I or three infusions spaced at least seven days apart during Phase IIa. A placebo group is included in Phase IIa for comparison. The study involves randomized assignment to different dose cohorts or placebo groups, with careful monitoring of safety and hormone levels. The trial also tracks several biological markers related to ovarian function. Throughout the study, participants will undergo regular assessments including hormone tests FSH, estradiol, AMH, ultrasound scans for follicle counts and endometrial thickness, and evaluations of menstrual recovery and symptoms. Safety is monitored over 48 weeks, with researchers recording any adverse events. The study runs from screening through treatment and follow-up, lasting several months to capture both short- and long-term effects of the infusions.

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