Intra-articular injection of expanded autologous bone marrow mesenchymal cells in moderate and severe knee osteoarthritis is safe: a phase I/II study
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 ai...
| Main Authors: | , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2017-12-01
|
| Series: | Journal of Orthopaedic Surgery and Research |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s13018-017-0689-6 |
| _version_ | 1798039523412672512 |
|---|---|
| author | Mahasen Al-Najar Hiba Khalil Jihad Al-Ajlouni Eman Al-Antary Mohammad Hamdan Reem Rahmeh Dana Alhattab Osama Samara Mohamad Yasin Amenah Al Abdullah Esraa Al-jabbari Dima Hmaid Hanan Jafar Abdalla Awidi |
| author_facet | Mahasen Al-Najar Hiba Khalil Jihad Al-Ajlouni Eman Al-Antary Mohammad Hamdan Reem Rahmeh Dana Alhattab Osama Samara Mohamad Yasin Amenah Al Abdullah Esraa Al-jabbari Dima Hmaid Hanan Jafar Abdalla Awidi |
| author_sort | Mahasen Al-Najar |
| collection | DOAJ |
| description | 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 |
| first_indexed | 2024-04-11T21:55:04Z |
| format | Article |
| id | doaj.art-ae55335428be445089a5fadd320c94ba |
| institution | Directory Open Access Journal |
| issn | 1749-799X |
| language | English |
| last_indexed | 2024-04-11T21:55:04Z |
| publishDate | 2017-12-01 |
| publisher | BMC |
| record_format | Article |
| series | Journal of Orthopaedic Surgery and Research |
| spelling | doaj.art-ae55335428be445089a5fadd320c94ba2022-12-22T04:01:08ZengBMCJournal of Orthopaedic Surgery and Research1749-799X2017-12-011211610.1186/s13018-017-0689-6Intra-articular injection of expanded autologous bone marrow mesenchymal cells in moderate and severe knee osteoarthritis is safe: a phase I/II studyMahasen Al-Najar0Hiba Khalil1Jihad Al-Ajlouni2Eman Al-Antary3Mohammad Hamdan4Reem Rahmeh5Dana Alhattab6Osama Samara7Mohamad Yasin8Amenah Al Abdullah9Esraa Al-jabbari10Dima Hmaid11Hanan Jafar12Abdalla Awidi13Department of Radiology, School of Medicine, University of JordanDepartment of Hematology, Faculty of Medical Laboratory Sciences, Alneelain UniversityDepartment of Orthopedics, School of Medicine, University of JordanSchool of Medicine, University of JordanDepartment of Orthopedics, School of Medicine, University of JordanCell Therapy Center, University of JordanCell Therapy Center, University of JordanDepartment of Radiology, School of Medicine, University of JordanDepartment of Orthopedics, School of Medicine, University of JordanDepartment of Radiology, School of Medicine, University of JordanDepartment of Radiology, School of Medicine, University of JordanDepartment of Radiology, School of Medicine, University of JordanCell Therapy Center, University of JordanCell Therapy Center, University of JordanAbstract 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, NCT02118519http://link.springer.com/article/10.1186/s13018-017-0689-6Knee osteoarthritisMesenchymal stem cellsBone marrowKOOS scoreIntra-articular injection |
| spellingShingle | Mahasen Al-Najar Hiba Khalil Jihad Al-Ajlouni Eman Al-Antary Mohammad Hamdan Reem Rahmeh Dana Alhattab Osama Samara Mohamad Yasin Amenah Al Abdullah Esraa Al-jabbari Dima Hmaid Hanan Jafar Abdalla Awidi 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 Knee osteoarthritis Mesenchymal stem cells Bone marrow KOOS score Intra-articular injection |
| title | Intra-articular injection of expanded autologous bone marrow mesenchymal cells in moderate and severe knee osteoarthritis is safe: a phase I/II study |
| title_full | Intra-articular injection of expanded autologous bone marrow mesenchymal cells in moderate and severe knee osteoarthritis is safe: a phase I/II study |
| title_fullStr | Intra-articular injection of expanded autologous bone marrow mesenchymal cells in moderate and severe knee osteoarthritis is safe: a phase I/II study |
| title_full_unstemmed | Intra-articular injection of expanded autologous bone marrow mesenchymal cells in moderate and severe knee osteoarthritis is safe: a phase I/II study |
| title_short | Intra-articular injection of expanded autologous bone marrow mesenchymal cells in moderate and severe knee osteoarthritis is safe: a phase I/II study |
| title_sort | intra articular injection of expanded autologous bone marrow mesenchymal cells in moderate and severe knee osteoarthritis is safe a phase i ii study |
| topic | Knee osteoarthritis Mesenchymal stem cells Bone marrow KOOS score Intra-articular injection |
| url | http://link.springer.com/article/10.1186/s13018-017-0689-6 |
| work_keys_str_mv | AT mahasenalnajar intraarticularinjectionofexpandedautologousbonemarrowmesenchymalcellsinmoderateandseverekneeosteoarthritisissafeaphaseiiistudy AT hibakhalil intraarticularinjectionofexpandedautologousbonemarrowmesenchymalcellsinmoderateandseverekneeosteoarthritisissafeaphaseiiistudy AT jihadalajlouni intraarticularinjectionofexpandedautologousbonemarrowmesenchymalcellsinmoderateandseverekneeosteoarthritisissafeaphaseiiistudy AT emanalantary intraarticularinjectionofexpandedautologousbonemarrowmesenchymalcellsinmoderateandseverekneeosteoarthritisissafeaphaseiiistudy AT mohammadhamdan intraarticularinjectionofexpandedautologousbonemarrowmesenchymalcellsinmoderateandseverekneeosteoarthritisissafeaphaseiiistudy AT reemrahmeh intraarticularinjectionofexpandedautologousbonemarrowmesenchymalcellsinmoderateandseverekneeosteoarthritisissafeaphaseiiistudy AT danaalhattab intraarticularinjectionofexpandedautologousbonemarrowmesenchymalcellsinmoderateandseverekneeosteoarthritisissafeaphaseiiistudy AT osamasamara intraarticularinjectionofexpandedautologousbonemarrowmesenchymalcellsinmoderateandseverekneeosteoarthritisissafeaphaseiiistudy AT mohamadyasin intraarticularinjectionofexpandedautologousbonemarrowmesenchymalcellsinmoderateandseverekneeosteoarthritisissafeaphaseiiistudy AT amenahalabdullah intraarticularinjectionofexpandedautologousbonemarrowmesenchymalcellsinmoderateandseverekneeosteoarthritisissafeaphaseiiistudy AT esraaaljabbari intraarticularinjectionofexpandedautologousbonemarrowmesenchymalcellsinmoderateandseverekneeosteoarthritisissafeaphaseiiistudy AT dimahmaid intraarticularinjectionofexpandedautologousbonemarrowmesenchymalcellsinmoderateandseverekneeosteoarthritisissafeaphaseiiistudy AT hananjafar intraarticularinjectionofexpandedautologousbonemarrowmesenchymalcellsinmoderateandseverekneeosteoarthritisissafeaphaseiiistudy AT abdallaawidi intraarticularinjectionofexpandedautologousbonemarrowmesenchymalcellsinmoderateandseverekneeosteoarthritisissafeaphaseiiistudy |