NCT07510139

A Clinical Study of Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes for the Treatment of Premature Ovarian Insufficiency

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: International Peace Maternity and Child Health Hospital · Academic / Other
• Sex: Female
• Age: 20 Years – 39 Years
• Healthy volunteers: Not accepted

Summary

Clinical Study of Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes in the Treatment of Premature Ovarian Insufficiency

Detailed description

Premature ovarian insufficiency (POI) is a devastating disease for young women who have not yet completed childbearing.The current clinical diagnostic criteria for POI include oligomenorrhea or amenorrhea lasting more than 4 months before the age of 40, along with two measurements of serum follicle-stimulating hormone (FSH) levels \>25 IU/L, taken at least 4 weeks apart. Given the progressive nature of POI, recent domestic expert consensus has proposed the concept of "subclinical POI", defined by FSH levels of 15-25 IU/L, which may facilitate early identification and intervention in clinical practice. As the etiology of POI remains incompletely understood, early-stage patients often present with non-specific clinical manifestations, rapid disease progression, and once ovarian function is exhausted, there are currently no effective therapies to fundamentally restore it. Therefore, early intervention in high-risk women with fertility needs is of particular clinical importance. This interventional, open-label clinical study is designed to evaluate the safety and efficacy of intra-ovarian administration of YT023 in women with premature ovarian insufficiency (POI). The study aims to assess whether YT023 can improve ovarian function.

Conditions

• Premature Ovarian Insufficiency

Interventions

Type	Name	Description
BIOLOGICAL	YT023	YT023 is administered via in situ (intra-ovarian) injection
OTHER	Control Arm (Conventional Therapy)	The control group will receive assisted reproductive therapy in accordance with the standard of care at the study site

Timeline

• Start date: 2026-03-20
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2026-04-03
• Last updated: 2026-04-03

Locations

1 site across 1 country: China