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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Premature Ovarian Insufficiency
• Intervention / Treatment: Biological: YT023; Other: Control Arm (Conventional Therapy)

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • International Peace Maternity & Child Health Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Able to understand and voluntarily sign the informed consent form (ICF) prior to the initiation of any study-related assessments or procedures; Aged 20 to 39 years (inclusive) at the time of signing the ICF; Meets the diagnostic criteria for premature ovarian insufficiency (POI) ; Has a normal karyotype and no known history of FMR1 premutation (Fragile X syndrome); Has at least one ovary intact.

Exclusion Criteria:

History of primary malignancy; Subjects who are hepatitis B surface antigen (HBsAg)-positive at screening; subjects who are HBsAg-negative but hepatitis B core antibody (HBcAb)-positive with detectable peripheral blood hepatitis B virus (HBV) DNA above the lower limit of detection; subjects who are hepatitis C virus (HCV) antibody-positive with detectable HCV RNA; or subjects who are human immunodeficiency virus (HIV) antibody-positive; Known hypersensitivity to any component of the study treatments; Severe neurocognitive impairment as judged by the investigator; Any comorbidities or other conditions that, in the investigator's opinion, may affect compliance with the protocol or render the subject unsuitable for participation in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: YT023; YT023 treatment group will receive assisted reproductive therapy in accordance with the standard of care at the study site after YT023 treatment	Biological: YT023; YT023 is administered via in situ (intra-ovarian) injection
Other: Control arm; The control group will receive assisted reproductive therapy in accordance with the standard of care at the study site	Other: Control Arm (Conventional Therapy); The control group will receive assisted reproductive therapy in accordance with the standard of care at the study site

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the incidence, severity, and relationship of adverse events (AEs) and serious adverse events (SAEs).		2years
Improvement in ovarian reserve function following YT023 treatment.	Changes in ovarian reserve function following YT023 treatment, including levels of follicle-stimulating hormone (FSH), anti-Müllerian hormone (AMH), estradiol (E2), and antral follicle count (AFC).	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the clinical benefit of changes in patient-reported quality of life.	Fertility Quality of Life (FertiQoL) questionnaire	2years

Collaborators and Investigators

• Sponsor: International Peace Maternity and Child Health Hospital
• Collaborators: Shanghai Yuantian Biotechnology Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: March 22, 2026
• First Submitted That Met QC Criteria: March 27, 2026
• First Posted (Actual): April 3, 2026

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: March 27, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: POI
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Primary Ovarian Insufficiency
• Other Study ID Numbers: YT023-POI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No