Study of Human Amniotic Mesenchymal Stem Cells with Hormone Therapy for Treating Premature Ovarian Insufficiency in Women Aged 20 to 40

What this Trial Is About

Researchers are studying women aged 20 to 40 years who have Primary Ovarian Insufficiency POI, a condition where the ovaries stop functioning normally before age 40. This study aims to evaluate the safety of a new cell therapy using human amniotic mesenchymal stem cells hA-MSCs combined with hormone therapy. The trial compares this stem cell treatment to conventional hormone replacement therapy to better understand potential benefits for ovarian function. Participants are divided into two groups one receives hormone replacement therapy with Climen tablets, and the other receives the same hormone therapy plus intravenous infusions of hA-MSCs. The stem cell group receives infusions on the third day after menstruation starts and again one month later. The Climen tablets are taken daily for seven days, followed by a seven-day break, repeated for two cycles. During the study, participants are monitored every two weeks for safety indicators like temperature, pulse, breathing rate, and blood pressure over 24 weeks. Researchers also measure hormone levels and follicle growth to assess treatment effects. Pregnancy outcomes will be followed for up to 12 months. The study is designed to closely track participant health and ovarian function throughout the trial period.

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