Intra-articular injection of expanded autologous bone marrow mesenchymal cells in moderate and severe knee osteoarthritis is safe: a phase I/II study
| Autor: | Dana Alhattab, Reem Rahmeh, Jihad M. Al-Ajlouni, Eman T. Al-Antary, Amenah Al Abdullah, Hiba B. Khalil, Hanan Jafar, Abdalla Awidi, Esraa Al-jabbari, Mohamad Yasin, Dima Hmaid, Osama A. Samara, Mohammad O. Hamdan, Mahasen Al-Najar |
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| Jazyk: | angličtina |
| Rok vydání: | 2017 |
| Předmět: |
Adult
Male 0301 basic medicine medicine.medical_specialty lcsh:Diseases of the musculoskeletal system Osteoarthritis Mesenchymal Stem Cell Transplantation Severity of Illness Index Transplantation Autologous Injections Intra-Articular 03 medical and health sciences lcsh:Orthopedic surgery medicine Humans Orthopedics and Sports Medicine Bone marrow Prospective Studies Adverse effect KOOS score Cells Cultured medicine.diagnostic_test business.industry Cartilage Magnetic resonance imaging Middle Aged Osteoarthritis Knee medicine.disease Surgery Clinical trial lcsh:RD701-811 030104 developmental biology medicine.anatomical_structure Intra-articular injection Orthopedic surgery Mesenchymal stem cells Female Knee osteoarthritis Stem cell lcsh:RC925-935 business Follow-Up Studies Research Article |
| Zdroj: | Journal of Orthopaedic Surgery and Research, Vol 12, Iss 1, Pp 1-6 (2017) Journal of Orthopaedic Surgery and Research |
| DOI: | 10.1186/s13018-017-0689-6 |
| Popis: | Background Knee osteoarthritis (KOA) is a major health problem especially in the aging population. There is a need for safe treatment that restores the cartilage and reduces the symptoms. The use of stem cells is emerging as a possible option for the moderate and severe cases. This study aimed at testing the safety of autologous bone marrow mesenchymal stem cells (BM-MSCs) expanded in vitro when given intra-articularly to patients with stage II and III KOA. As a secondary end point, the study tested the ability of these cells to relieve symptoms and restore the knee cartilage in these patients as judged by normalized knee injury and Osteoarthritis Outcome Score (KOOS) and by magnetic resonance imaging (MRI). Methods Thirteen patients with a mean age of 50 years suffering from KOA stages II and III were given two doses of BM-MSCs 1 month apart totaling 61 × 106 ± 0.6 × 106 by intra-articular injection in a phase I prospective clinical trial. Each patient was followed for a minimum of 24 months for any adverse events and for clinical outcome using normalized KOOS. Cartilage thickness was assessed by quantitative MRI T2 at 12 months of follow-up. Results No severe adverse events were reported up to 24 months follow-up. Normalized KOOS improved significantly. Mean knee cartilage thickness measured by MRI improved significantly. Conclusion BM-MSCs given intra-articularly are safe in knee osteoarthrosis. Despite the limited number of patients in this study, the procedure described significantly improved the KOOS and knee cartilage thickness, indicating that they may enhance the functional outcome as well as the structural component. Trial registration ClinicalTrials.gov, NCT02118519 |
| Databáze: | OpenAIRE |
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