NCT01586312

Treatment of Knee Osteoarthritis With Allogenic Mesenchymal Stem Cells

Treatment of Knee Osteoarthritis With Allogenic Mesenchymal Stem Cells (MSV*) *MSV: Mesenchymal Stromal Cells From Valladolid

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Red de Terapia Celular · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

In this study we want to evaluate the clinical use of allogenic mesenchymal stem cells (MSC), obtained from bone marrow of healthy donors, for treatment of knee osteoarthritis. The trial is based in our own previous results with autologous MSC (ongoing NCT01183728 trial). We propose here a multicenter, phase I-II clinical trial, prospective, randomized, blinded, and controlled for the treatment of osteoarthritis (degrees II and III and IV). The assay consists of two arms with 15 patients each one. Patients in the experimental arm will be given an intra-articular transplantation of allogenic MSC, expanded "Ex Vivo" with our GMP-compliant procedure (MSV, PEI No. 10-134, authorized by the Competent Authority; same as in NCT01183728). In the control arm a standard treatment with intra-articular injection of hyaluronic acid shall be given. We shall follow the evolution of pain, disability, quality of life and quantitative changes in structure and composition of cartilage determined by T2-weighted MRI relaxation (Cartigram) for one year.

Conditions

• Osteoarthritis, Knee
• Arthritis of Knee
• Knee Osteoarthritis

Interventions

Type	Name	Description
OTHER	Allogenic mesenchymal stromal cells injection	Mesenchymal stem cells prepared from bone marrow of healthy donors and expanded for 3-4 weeks according to our procedure described in PEI Num. 10-134, authorized by the Spanish Medicine Agency
DRUG	Hyaluronic Acid	Intra-articular injection of 60 mg of hyaluronic acid (Durolane) in a single injection (3 ml)

Timeline

• Start date: 2012-04-01
• Primary completion: 2013-12-01
• Completion: 2014-06-01
• First posted: 2012-04-26
• Last updated: 2015-10-16
• Results posted: 2014-11-06

Locations

2 sites across 1 country: Spain