Status:
RECRUITING
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for PCOS
Lead Sponsor:
The Foundation for Orthopaedics and Regenerative Medicine
Conditions:
Polycystic Ovary Syndrome (PCOS)
Polycystic Ovary Syndrome
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief Summary
This trial will study the safety and efficacy of cultured allogeneic adult umbilical cord derived mesenchymal stem cells delivered intravenously for the treatment of Polycystic Ovary Syndrome.
Detailed Description
Stem cell treatment has shown efficacy for PCOS in both human and animal studies. Complete resolution was seen of polycystic ovary syndrome (PCOS) in a young woman after a single intravenous injection...
Eligibility Criteria
Inclusion
- • Ultrasound documented poly cystic ovary syndrome
Exclusion
- 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
Key Trial Info
Start Date :
November 16 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 16 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06143527
Start Date
November 16 2023
End Date
November 16 2027
Last Update
April 8 2025
Active Locations (2)
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1
Medical Surgical Associates Center
St John's, Antigua and Barbuda
2
Athens Beverly Hills Medical Group
Glyfada, Greece, 16675