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Stem cell gene therapy for early menopause: 2.5-Year Follow-Up shows promise

NCT ID NCT04675970

Disease control Sponsor: Ukraine Association of Biobank 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study followed 86 women under 40 with premature ovarian failure (early menopause) who had received a one-time gene therapy using their own stem cells. The goal was to check long-term safety and see if hormone levels and fertility improved over 2.5 years. No new treatment was given during follow-up; researchers measured ovarian function and pregnancy rates.

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.

Participants

86 people

The number who actually took part.

Started

Sep 2020

Finished

Sep 2025

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.

Who is studied

Patients with premature ovarian insufficiency (Diagnostic criteria of ESHRE) who have been treated with ex vivo gene therapy product in a Institute Bio-Stem Cell Rehabilitation UAB clinical study.

Ages

18 to 40 years

Sex

Female participants only

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: Provision of written informed consent for this study by subjects or as applicable parent legal guardian. Treated with drug product for therapy of premature ovarian insufficiency in a Institute Bio-Stem Cell Rehabilitation UAB clinical study. Diagnosed of premature ovarian insufficiency ESHRE: * Women age of 18 to 40 years * Have experienced 4 months of oligo/amenorrhea * Two serum follicle-stimulating hormone (FSH was \>40 mIU/ml levels in the menopausal range, obtained at least a month apart * lower FSH levels ( 25 mIU/ml) * anti-Müllerian hormone (AMH) serum levels ( 3.0 ng/ml) Exclusion Criteria: There are no exclusion criteria for this study

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Conditions

The condition(s) this trial relates to.

premature menopause primary ovarian failure

As listed by the trial registrant

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

Premature ovarian failure Primary ovarian insufficiency

Contacts and locations

Locations

  • Institute of Bio-Stem Cell Rehabilitation

    Kharkiv, Ukraine

More trials for these conditions

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