Intra-articular injection of expanded autologous bone marrow mesenchymal cells in moderate and severe knee osteoarthritis is safe: a phase I/II study

Journal of Orthopaedic Surgery and Research

Dana Alhattab¹  Hanan Jafar¹  Abdalla Awidi¹  Reem Rahmeh¹  Hiba Khalil²  Jihad Al-Ajlouni³  Mohammad Hamdan³  Mohamad Yasin³  Mahasen Al-Najar⁴  Esraa Al-jabbari⁴  Osama Samara⁴  Amenah Al Abdullah⁴  Dima Hmaid⁴  Eman Al-Antary⁵ 

[1] Cell Therapy Center, University of Jordan;Department of Hematology, Faculty of Medical Laboratory Sciences, Alneelain University;Department of Orthopedics, School of Medicine, University of Jordan;Department of Radiology, School of Medicine, University of Jordan;School of Medicine, University of Jordan;

关键词: Knee osteoarthritis;    Mesenchymal stem cells;    Bone marrow;    KOOS score;    Intra-articular injection;   

DOI  :  10.1186/s13018-017-0689-6

来源: DOAJ

【 摘 要 】

Abstract 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

【 授权许可】

Unknown