NCT06143527

Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for PCOS

Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for the Treatment of Polycystic Ovary Syndrome

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: The Foundation for Orthopaedics and Regenerative Medicine · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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 of umbilical cord derived mesenchymal stem cells (UCDSC). It is hypothesized that intravenous infusion of UCDSC can reduce or eliminate PCOS. Patients will receive roughly 2 million umbilical cord derived mesenchymal stem cells per kg of body weight. Hormone levels and ultrasound will be checked 3,6 and 12 months after treatment.

Conditions

• Polycystic Ovary Syndrome (PCOS)
• Polycystic Ovary Syndrome
• PCOS

Interventions

Type	Name	Description
BIOLOGICAL	AlloRx	Cultured allogeneic adult umbilical cord derived mesenchymal stem cells

Timeline

• Start date: 2023-11-16
• Primary completion: 2027-11-16
• Completion: 2027-11-16
• First posted: 2023-11-22
• Last updated: 2025-04-08

Locations

2 sites across 2 countries: Antigua and Barbuda, Greece

Regulatory

• FDA-regulated drug study