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Could stem cells help women with PCOS get pregnant?

NCT ID NCT05279768

Disease control Sponsor: PT. Prodia Stem Cell Indonesia 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested whether umbilical cord stem cells and their secretions (secretomes) can help women with polycystic ovary syndrome (PCOS) who also have insulin resistance. 44 women received either stem cells, secretomes, both, or a control treatment. The goal was to see if these treatments could improve insulin resistance and hormone levels, potentially aiding fertility.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
umbilical cord mesenchymal stem cells and secretomes
What this could lead to
If it works, this could point toward a new treatment for infertility in women with PCOS and insulin resistance.
What could go wrong
This is an early Phase 1/2 trial with only 44 participants, so results may not apply to everyone. The treatment is experimental and may not improve fertility or 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

44 people

The number who actually took part.

Started

Sep 2022

Finished

Jan 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

20 to 40 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: * PCOS patients with insulin resistance based on Rotterdam Consensus criteria, i.e. menstrual disorders (oligomenorhea/ amennorhea) * Patients must have hiperandrogenemia clinical and laboratory proof (Ferriman Gallwey score \>8) * Patients with Free Androgen Index (FAI) \>4 and ovary polycystic from USG transvaginal * Patients with Homeostatic (HOMA) IR score ≥ 1.7 Exclusion Criteria: * Patients who are allergic to component of WJ-MSC or Secretome. * Patients who are not currently on hormon treatment of other resistance treatment. * Refusing or not participating in part / all of the research process. * Patients with positive diagnosis of hepatitis A,B,C, and HIV

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Conditions

The condition(s) this trial relates to.

polycystic ovary syndrome

As listed by the trial registrant

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

Polycystic ovary syndrome

Contacts and locations

Locations

  • PT Prodia StemCell Indonesia

    Jakarta, Indonesia

More trials for these conditions

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