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Ĭurrently used modalities for the treatment of post-traumatic OA address the symptoms that arise subsequent to the initiating injury but, apart from their analgesic and anti-inflammatory activities, offer limited value in restoring the joint structural changes induced by the initial traumatic event or diminishing the progression to symptomatic OA. Moreover, there is no evidence that ACL reconstruction improves knee joint structural outcomes and the onset of OA. Approximately 80% of patients with traumatic rupture of the ACL show evidence of radiographic OA within 12–14 years following the injury, despite surgical repair. Individuals who sustained an ACL rupture account for an estimated 25% of the overall knee OA population. Anterior cruciate ligament (ACL) rupture is a relatively common injury, particularly during sporting activities. Post-traumatic OA affects 5.6 million individuals in the United States with an annual direct medical cost of approximately $3 billion. For approximately 12% of the OA population the condition is considered to arise secondary to a traumatic injury, leading to the classification of this group of patients as presenting with post-traumatic OA. Joint injury is also a well-established risk factor for the development of OA. It is a disease with a multifactorial aetiology, with obesity, ageing, occupational, hormonal, and genetic factors considered to be important contributors to its onset and progression. Osteoarthritis (OA) is a widespread debilitating chronic condition that causes joint pain, functional disability, and impaired quality of life.
#Change resolution on martin mpc registration#
Trial registrationĬ ( NCT01088191) registration date: March 11, 2010 These findings suggest that MPCs warrant further investigations as they may modulate some of the pathological processes responsible for the development of post-traumatic osteoarthritis following ACL reconstruction. Intra-articular administration of a single allogeneic MPC injection following ACL reconstruction was safe, well tolerated, and may improve symptoms and structural outcomes. The MPC + HA group had reduced medial and lateral tibiofemoral joint space narrowing ( p < 0.05), less tibial bone expansion (0.5% vs 4.0% over 26 weeks, p = 0.02), and a trend towards reduced tibial cartilage volume loss (0.7% vs –4.0% over 26 weeks, p = 0.10) than the HA controls. Compared with the HA group, MPC + HA-treated patients showed greater improvements in KOOS pain, symptom, activities of daily living, and SF-36 bodily pain scores ( p < 0.05). Increases in class I PRA >10% were observed at week 4 in the MPC + HA group that decreased to baseline levels by week 104.
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No cell-related serious adverse effects were observed.
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Moderate arthralgia and swelling within 24 h following injection that subsided were observed in 4 out of 11 in the MPC + HA group and 0 out of 6 HA controls. Joint space width was measured from radiographs, and tibial cartilage volume and bone area assessed from magnetic resonance imaging (MRI). Pain, function, and quality of life were assessed using the Knee Injury and Osteoarthritis Outcome Score (KOOS) and SF-36v2 scores. Immunogenicity was evaluated by anti-HLA panel reactive antibodies (PRA) against class I and II HLAs determined by flow cytometry.
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Patients were monitored for adverse events. In this phase Ib/IIa, double-blind, active comparator clinical study, 17 patients aged 18–40 years with unilateral ACL reconstruction were randomized (2:1) to receive either a single intra-articular injection of 75 million allogeneic MPCs suspended in hyaluronan (HA) (MPC + HA group) ( n = 11) or HA alone ( n = 6). The objectives of this pilot study were to determine the safety and tolerability and to explore the efficacy of a single intra-articular injection of allogeneic human mesenchymal precursor cells (MPCs) to improve clinical symptoms and retard joint structural deterioration over 24 months in patients following anterior cruciate ligament (ACL) reconstruction. Few clinical trials have investigated the safety and efficacy of mesenchymal stem cells for the management of post-traumatic osteoarthritis.