Clinical trial Recruiting at 2 sites Phase 1 Interventional Ages 18 and up Women only

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.

More Polycystic Ovary Syndrome trials

Quick facts

PhasePhase 1
Study typeInterventional
Ages18 Years and up
SexWomen only
Enrollment20 (estimated)
SponsorThe Foundation for Orthopaedics and Regenerative Medicine
Academic / other
Locations2 sites (Naples, Florida and 1 other locations)
StatusRecruiting
StartedNovember 16, 2023
Main results expectedNovember 16, 2027
Study endsNovember 16, 2027
Registry record updatedOctober 20, 2026
Trial IDNCT06143527 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

  • Prodromos Stem Cell Institute
    Naples, Florida, United States
    Recruiting
  • Prodromos Stem Cell Institute
    Athens, Greece
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • Using LC-MS/MS to profile androgens for PCOS diagnosis

    This study tests whether LC-MS/MS measurement of androgen profiles can help diagnose PCOS in women compared with healthy controls.

    Recruiting Women's Hospital School Of Medicine Zhejiang University · Hangzhou, Zhejiang · NCT07916909

  • Brown adipose tissue responses in PCOS with infrared thermography and inositol

    This study tests whether brown fat activity, measured by infrared skin temperature and UCP-1 levels, differs among women with PCOS (normal weight or overweight/obese) and healthy controls, and whether 12 weeks of inositol changes those responses in overweight/obese PCOS participants.

    Recruiting at 2 sites Istanbul Health and Technology University · Istanbul and 1 other locations · NCT07896642

  • PMOS and Sleep Apnea: A Pilot Look at Mitochondrial Function

    In women with PMOS, this pilot study tests whether sleep apnea treatment with CPAP improves mitochondrial function in leg muscle tissue.

    Recruiting University of Chicago · Chicago, Illinois · NCT07871149

  • Precision acupuncture and lifestyle for PCOS

    This trial tests whether a precision acupuncture approach combined with a personalized lifestyle plan helps improve insulin resistance in people with PCOS compared with conventional acupuncture and standard lifestyle changes.

    Recruiting Peking University Third Hospital · Beijing, Beijing Municipality and 1 other locations · NCT07809503

  • Orlistat for metabolic and hormonal features in women with PCOS

    This trial tests whether adding orlistat to lifestyle advice helps improve metabolic and hormonal aspects in women with PCOS compared to lifestyle advice alone.

    Recruiting Khyber Medical University Peshawar · Abbottābād, Khyber Pakhtunkhwa · NCT07747909

  • PCOS and Brain Health

    This study tests how PCOS may affect brain blood flow, brain structure, and thinking skills in reproductive-age people with and without PCOS.

    Recruiting University of Wisconsin, Madison · Madison, Wisconsin · NCT07727512

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.