Conditions: Osteoarthritis, Knee Arthritis of Knee Knee Osteoarthritis
Keywords: Knee degenerative disease osteoarthritis gonarthrosis stem cell cellular therapy regenerative therapy Mesenchymal stem cells Bone marrow musculoskeletal Diseases Mesenchymal Stromal Cells (allogenic)
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 30
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Mesenchymal stem cells (MSC) prepared from bone marrow from healthy donor expanded ex vivo for 3-4 weeks. Intraarticular injection of 40 millions MSC. arm 2: Intraarticular injection of hyaluronic acid (60 mg)

Interventions: intervention 1: Allogenic mesenchymal stromal cells injection intervention 2: Hyaluronic Acid
Intervention descriptions: intervention 1: 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 intervention 2: Intra-articular injection of 60 mg of hyaluronic acid (Durolane) in a single injection (3 ml)

Protocol document: