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Clinical Trial
. 2017 Dec 12;12(1):190.
doi: 10.1186/s13018-017-0689-6.

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

Mahasen Al-Najar  1 , Hiba Khalil  2 , Jihad Al-Ajlouni  3 , Eman Al-Antary  4 , Mohammad Hamdan  3 , Reem Rahmeh  5 , Dana Alhattab  5 , Osama Samara  1 , Mohamad Yasin  3 , Amenah Al Abdullah  1 , Esraa Al-Jabbari  1 , Dima Hmaid  1 , Hanan Jafar  5 , Abdalla Awidi  6   7
Affiliations
Clinical Trial

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

Mahasen Al-Najar et al. J Orthop Surg Res. .

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.

Keywords: Bone marrow; Intra-articular injection; KOOS score; Knee osteoarthritis; Mesenchymal stem cells.

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Conflict of interest statement

Ethics approval and consent to participate

This research was approved by the institutional review board at Jordan University Hospital. All patients were fully informed about the aim and procedures of this work. They were asked to sign a consent formulated in accordance with the Helsinki Declaration. The informed consent included statements authorizing publication of the results.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

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Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Flow cytometry analysis of BM-MSCs surface marker expression
Fig. 2
Fig. 2
Representative sample of BM-MSCs. A Osteogenic and B adipogenic differentiation
See this image and copyright information in PMC

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