NCT05086939

Multicenter Clinical Trial Comparing Treatment with Allogeneic Mesenchymal Cells Versus Autologous Mesenchymal Cells and Versus Active Control with Hyaluronic Acid in Patients with Knee Osteoarthritis.

Phase III, Multicenter, Randomized, Open-label Clinical Trial Comparing Treatment with Allogeneic Mesenchymal Cells Versus Autologous Mesenchymal Cells and Versus Active Control with Hyaluronic Acid in Patients with Knee Osteoarthritis

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Phase III, multicenter, randomized, open-label, multicenter clinical trial comparing treatment with allogeneic mesenchymal cells versus autologous mesenchymal cells and versus active control with hyaluronic acid in patients with knee osteoarthritis.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
DRUG	Autologous MSCs	Intra-articular injection 40 million/4 ml.
DRUG	Allogenic MSCs	Intra-articular injection 40 million/4 ml.
DRUG	Hyaluronic Acid	Intra-articular injection 60mg / 3 ml .

Timeline

• Start date: 2021-05-26
• Primary completion: 2025-05-01
• Completion: 2026-05-01
• First posted: 2021-10-21
• Last updated: 2024-11-29

Locations

8 sites across 1 country: Spain