Using stem cells from umbilical cords to treat Polycystic Ovary Syndrome
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for the Treatment of Polycystic Ovary Syndrome
PHASE1 · The Foundation for Orthopaedics and Regenerative Medicine · NCT06143527
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 | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | The Foundation for Orthopaedics and Regenerative Medicine (other) |
| Locations | 2 sites (St John's and 1 other locations) |
| Trial ID | NCT06143527 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women diagnosed with ultrasound-confirmed Polycystic Ovary Syndrome.
Not a fit: Patients with active infections, cancers, or other significant health issues may not benefit from this study.
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 performed: Previous studies have shown promising results with stem cell treatments for PCOS, suggesting potential for success in this approach.
Eligibility criteria
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 this trial is running
St John's and 1 other locations
- Medical Surgical Associates Center — St John's, Antigua and Barbuda (RECRUITING)
- Athens Beverly Hills Medical Group — Glyfada, Greece (RECRUITING)
Study contacts
- Principal investigator: Chadwick C Prodromos, MD — The Foundation for Orthopaedics and Regenerative Medicine
- Study coordinator: Chadwick C Prodromos, MD
- Email: research@ismoc.net
- Phone: 8476996810
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Polycystic Ovary Syndrome, PCOS, Stem Cell, Stem Cells, Mesenchymal Stem Cells, Umbilical Cord Derived Mesenchymal Stem Cells