A Clinical Study of Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes for the Treatment of Pr… (NCT07510139) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
A Clinical Study of Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes for the Treatment of Premature Ovarian Insufficiency
China60 participantsStarted 2026-03-20
Plain-language summary
Clinical Study of Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes in the Treatment of Premature Ovarian Insufficiency
Who can participate
Age range20 Years – 39 Years
SexFEMALE
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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
What they're measuring
1
To evaluate the incidence, severity, and relationship of adverse events (AEs) and serious adverse events (SAEs).
Timeframe: 2years
2
Improvement in ovarian reserve function following YT023 treatment.
Timeframe: 2 years
Trial details
NCT IDNCT07510139
SponsorInternational Peace Maternity and Child Health Hospital