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Could stem cell exosomes restore fertility? new trial tests hope for early ovarian failure

NCT ID NCT07510139

Disease control Sponsor: International Peace Maternity and Child Health Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study tests whether exosomes from umbilical cord stem cells can help women with premature ovarian insufficiency (early menopause). The treatment aims to improve ovarian function and quality of life. About 60 women aged 20-39 will receive the experimental therapy, and researchers will monitor safety and hormone levels.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 to 39 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

primary ovarian failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Premature ovarian insufficiency

Contacts and locations

Locations

  • International Peace Maternity & Child Health Hospital

    Shanghai, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.