Background: Osteoarthritis is the most prevalent joint disease and a frequent cause of joint pain, functional loss, and disability. Osteoarthritis often becomes chronic, and conventional treatments have demonstrated only modest clinical benefits without lesion reversal. Cell-based therapies have shown encouraging results in both animal studies and a few human case reports. We designed a pilot study to assess the feasibility and safety of osteoarthritis treatment with mesenchymal stromal cells (MSCs) in humans and to obtain early efficacy information for this treatment.
Methods: Twelve patients with chronic knee pain unresponsive to conservative treatments and radiologic evidence of osteoarthritis were treated with autologous expanded bone marrow MSCs by intra-articular injection (40×106 cells). 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.
Results: Feasibility and safety were confirmed, and strong indications of clinical efficacy were identified. Patients exhibited rapid and progressive improvement of algofunctional indices that approached 65% to 78% by 1 year. This outcome compares favorably with the results of conventional treatments. Additionally, quantification of cartilage quality by T2 relaxation measurements demonstrated a highly significant decrease of poor cartilage areas (on average, 27%), with improvement of cartilage quality in 11 of the 12 patients.
Conclusions: MSC therapy may be a valid alternative treatment for chronic knee osteoarthritis. The intervention is simple, does not require hospitalization or surgery, provides pain relief, and significantly improves cartilage quality.
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1 Institut de Teràpia Regenerativa Tissular (ITRT), Centro Médico Teknon, Barcelona, Spain.
2 Instituto de Biología y Genética Molecular (IBGM), University of Valladolid and CSIC, Valladolid, Spain.
3 Servicio de Traumatología, EGARSAT, Terrassa, Spain.
4 Department of Magnetic Resonance Imaging, CETIR Clínica del Pilar, Barcelona, Spain.
5 Department of Public Health, Medical School, University of Barcelona, Barcelona, Spain.
6 Address correspondence to: Javier García-Sancho, M.D., Ph.D., Instituto de Biología y Genética Molecular (IBGM), University of Valladolid and CSIC, c/Sanz y Fores, 3, 47003 Valladolid, Spain.
Financial supports from Teknon Foundation of Barcelona, Program for Support of Independent Clinical Research of the Spanish Ministerio de Sanidad, Red de Terapia Celular (RD06/0010/0000) of the Instituto de Salud Carlos III, Ministerio de Economia y Competitividad, and Centro en Red de Medicina Regenerativa de Castilla y León are gratefully acknowledged. The sponsors had no role in the design and conduct of the study; the collection, management, analysis, and interpretation of the data; or the preparation, review, or approval of the article.
The authors declare no conflicts of interest.
J.G.-S. had full access to all of the data in the study and takes responsibility forthe integrity of the data and the accuracy of the data analysis. L.O., R.S., A.S., and J.G.-S. participated in the conception and design of this study. L.O., R.S., and F.S. were primarily responsible for the clinical work.A.M. was responsible for the clinical research and documentation. M.A. and A.S. were responsible for the cell production. M.H. was responsible for the MRI. J.S. was responsible for the statistical analysis. Allauthors participated in the analysis, discussion, and interpretation ofdata, contributed to the revision of the article, and gave final approvalof the version to be published. J.G.-S. organized all data, conductedmeta-analysis and image analysis, and wrote the final draft of the article.
Clinical trial registries: EudraCT 2009-017405-11 and NCT01183728.
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Received 22 January 2013. Revision requested 14 February 2013.
Accepted 11 March 2013.