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

Phase 2Active Not RecruitingNCT07510139

International Peace Maternity and Child Health Hospital60 enrolled

Overview

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

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

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Premature Ovarian Insufficiency

Interventions

YT023BIOLOGICAL

YT023 is administered via in situ (intra-ovarian) injection

Control Arm (Conventional Therapy)OTHER

The control group will receive assisted reproductive therapy in accordance with the standard of care at the study site

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 39 Years

Medical Language ↔ Plain English

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

Locations (1)

International Peace Maternity & Child Health Hospital

Shanghai, China

Outcomes

Primary Outcomes

To evaluate the incidence, severity, and relationship of adverse events (AEs) and serious adverse events (SAEs).

Time frame: 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).

Time frame: 2 years

Secondary Outcomes

To evaluate the clinical benefit of changes in patient-reported quality of life.

Fertility Quality of Life (FertiQoL) questionnaire

Time frame: 2years

Data from ClinicalTrials.gov

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