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Randomized Controlled Trial Multicenter Study
Treatment of Knee Osteoarthritis With Allogeneic Bone Marrow Mesenchymal Stem Cells: A Randomized Controlled Trial.
- Aurelio Vega, Miguel Angel Martín-Ferrero, Francisco Del Canto, Mercedes Alberca, Veronica García, Anna Munar, Lluis Orozco, Robert Soler, Juan Jose Fuertes, Marina Huguet, Ana Sánchez, and Javier García-Sancho.
- 1 Servicio de Traumatología, Hospital Clínico Universitario de Valladolid, Valladolid, Spain. 2 Instituto de Biología y Genética Molecular (IBGM), University of Valladolid and CSIC, Valladolid, Spain. 3 Institut de Teràpia Regenerativa Tissular (ITRT), Hospital Quirón Teknon, Barcelona, Spain. 4 Servicio de Radiología, Hospital Clínico Universitario de Valladolid, Valladolid, Spain. 5 Department of Magnetic Resonance Imaging, CETIR Clínica del Pilar, Barcelona, Spain.
- Transplantation. 2015 Aug 1; 99 (8): 1681-90.
BackgroundOsteoarthritis is the most prevalent joint disease and a common cause of joint pain, functional loss, and disability. Conventional treatments demonstrate only modest clinical benefits without lesion reversal. Autologous mesenchymal stromal cell (MSC) treatments have shown feasibility, safety, and strong indications for clinical efficacy. We performed a randomized, active control trial to assess the feasibility and safety of treating osteoarthritis with allogeneic MSCs, and we obtain information regarding the efficacy of this treatment.MethodsWe randomized 30 patients with chronic knee pain unresponsive to conservative treatments and showing radiological evidence of osteoarthritis into 2 groups of 15 patients. The test group was treated with allogeneic bone marrow MSCs by intra-articular injection of 40 × 10(6) cells. The control group received intra-articular hyaluronic acid (60 mg, single dose). Clinical outcomes were followed for 1 year and included evaluations of pain, disability, and quality of life. Articular cartilage quality was assessed by quantitative magnetic resonance imaging T2 mapping.ResultsFeasibility and safety were confirmed and indications of clinical efficacy were identified. The MSC-treated patients displayed significant improvement in algofunctional indices versus the active controls treated with hyaluronic acid. Quantification of cartilage quality by T2 relaxation measurements showed a significant decrease in poor cartilage areas, with cartilage quality improvements in MSC-treated patients.ConclusionsAllogeneic MSC therapy may be a valid alternative for the treatment of chronic knee osteoarthritis that is more logistically convenient than autologous MSC treatment. The intervention is simple, does not require surgery, provides pain relief, and significantly improves cartilage quality.
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