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This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.

NCT05279768

NCT05279768
Completed Phase 2

Who may be able to join

Who might be able to join this trial:

  • You have been diagnosed with Polycystic Ovary Syndrome (PCOS) with insulin resistance, and have irregular or absent periods.
  • You have signs of high male hormone (androgen) levels, confirmed by both a physical assessment (a body hair scoring system called the Ferriman Gallwey score above 8) and a blood test.
  • Your blood test shows a Free Androgen Index (a measure of male hormone levels) above 4, and an ultrasound scan of your ovaries has confirmed they are polycystic.
  • Your blood test shows a HOMA-IR score of 1.7 or higher, which is a measure used to assess insulin resistance.

Who may not be able to join:

  • You have a known allergy to the components used in the treatment being tested (called WJ-MSC or Secretome).
  • You are currently receiving hormone therapy or other treatments for insulin resistance.
  • You are unwilling or unable to take part in some or all parts of the research process.
  • You have tested positive for Hepatitis A, B, C, or HIV.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Completed
Phase
Phase 2
Sponsor
PT. Prodia Stem Cell Indonesia
Registry
clinicaltrials_gov
Start date
1 September 2022
Est. completion
20 January 2025

Where this trial is recruiting

🇮🇩 Indonesia

Primary endpoints

Blood serum sample; Free Androgen index (FAI); Insulin, Glucose Plasma, and Insulin Resistance; Sex Hormone Binding Globulin (SHBG) and Anti-Mullerian Hormone (AMH); Leptin and Adiponectine Profile; TNFα, IL-1 β, IL-6, IL-10 Profile

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov