Using stem cells from umbilical cords to treat Polycystic Ovary Syndrome
Official title: Safety of Cultured Allogeneic Adult Umbilical Cord or Placental Derived Mesenchymal Stem Cells for the Treatment of Polycystic Ovary Syndrome
Run by The Foundation for Orthopaedics and Regenerative Medicine · NCT06143527 · Data updated 2026-11-12
This study is testing whether stem cells from umbilical cords can help women with Polycystic Ovary Syndrome feel better and improve their symptoms.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 20 (estimated) |
| Sponsor | The Foundation for Orthopaedics and Regenerative Medicine Academic / other |
| Locations | 2 sites (Naples, Florida and 1 other locations) |
| Status | Recruiting |
| Started | November 16, 2023 |
| Main results expected | November 16, 2027 |
| Study ends | November 16, 2027 |
| Registry record updated | October 20, 2026 |
| Trial ID | NCT06143527 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women diagnosed with ultrasound-confirmed Polycystic Ovary Syndrome.
✕Probably not a fit
Patients with active infections, cancers, or other significant health issues may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This trial investigates the safety and efficacy of intravenous delivery of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for treating Polycystic Ovary Syndrome (PCOS). The study is based on previous findings that suggest stem cell treatment may resolve PCOS symptoms. Participants will receive approximately 2 million stem cells per kg of body weight, and their hormone levels and ultrasound results will be monitored at 3, 6, and 12 months post-treatment. The goal is to determine if this innovative approach can effectively reduce or eliminate the condition.
Why it matters
Potential benefit: If successful, this treatment could provide a novel and effective option for managing Polycystic Ovary Syndrome.
How similar studies have gone: Previous studies have shown promising results with stem cell treatments for PCOS, suggesting potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: • Ultrasound documented poly cystic ovary syndrome Exclusion Criteria: * Active infection * Active cancer * Chronic multisystem organ failure * Pregnancy * Clinically significant abnormalities on pre-treatment laboratory evaluation * Medical condition that would (based on the opinion of the investigator) compromise patient's safety * Continued drug abuse * Previous organ transplant * Hypersensitivity to sulfur * Inability to supply proper informed consent
Where it's running
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Prodromos Stem Cell Institute
Naples, Florida, United States Recruiting -
Prodromos Stem Cell Institute
Athens, Greece Recruiting
Study contacts
- Study coordinator: Chadwick Prodromos, MD
- Email: care@thepsci.com
- Phone: 847-699-6810
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.