NCT05147675

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

Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for the Treatment of Osteoarthritis

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 92 (estimated)
• Sponsor: The Foundation for Orthopaedics and Regenerative Medicine · Academic / Other
• Sex: All
• Age: —
• 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 and intraarticularly for the treatment of Osteoarthritis.

Detailed description

Studies have shown that stem cell treatment is safe and efficacious for the treatment of Osteoarthritis (OA). This patient funded trial aims to study the safety and efficacy of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (UC-MSCs) for the treatment of OA. Patients with OA will receive intravenous infusion and intraarticular injection of UC-MSCs. The total dose will be 100 million cells. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.

Conditions

• Osteoarthritis
• Spinal Arthritis

Interventions

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

Timeline

• Start date: 2022-12-01
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2021-12-07
• Last updated: 2025-06-10

Locations

2 sites across 2 countries: Antigua and Barbuda, Greece

Regulatory

• FDA-regulated drug study