Abstract
ObjectiveHuman adipose-derived mesenchymal progenitor cells (haMPCs) are stem cells with multiple differentiation potential and immunomodulatory function. Re-Join® comprises in vitro expanded haMPCs from adipose tissue of patients combined with cell suspension solution. This study was undertaken to evaluate the efficacy and safety of Re-Join® in patients with symptomatic knee osteoarthritis (OA).MethodsPatients with Kellgren–Lawrence grade 1–3 knee OA were recruited from two centers and randomized to receive intra-articular injection of Re-Join® or HA. Pain and function were assessed by using WOMAC score, VAS, and SF-36. Magnetic resonance imaging (MRI) analysis was performed to measure cartilage repair. Adverse events (AEs) were collected.ResultsFifty-three patients were randomized. Significant improvements in WOMAC, VAS, and SF-36 scores were observed in both groups at months 6 and 12 compared with baseline. Compared with the HA group, significantly more patients achieved 50% improvement of WOMAC and a trend of more patients achieved a 70% improvement rate in Re-Join® group after 12 months. Meanwhile, there was notably more increase in articular cartilage volume of both knees in the Re-Join® group than in the HA group after 12 months as measured by MRI. AEs were comparable between two groups. Most AEs were mild and moderate except one SAE of right knee joint infection in the HA group.ConclusionsSignificant improvements in joint function, pain, quality of life, and cartilage regeneration were observed in Re-Join®-treated knee OA patients with good tolerance in a period of 12 months.Trial registrationClinicalTrials.gov Identifier: NCT02162693. Registered 13 June 2014.
Highlights
Around 9.6% of men and 18% of women aged over 60 years old have symptomatic osteoarthritis (OA) across the world [1]
Significant improvements in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), visual analogue scale (VAS), and SF-36 scores were observed in both groups at months 6 and 12 compared with baseline
Compared with the hyaluronic acid (HA) group, significantly more patients achieved 50% improvement of WOMAC and a trend of more patients achieved a 70% improvement rate in Re-Join® group after 12 months
Summary
Around 9.6% of men and 18% of women aged over 60 years old have symptomatic osteoarthritis (OA) across the world [1]. The pathogenesis of OA is complex and not fully elucidated. Current treatments in early-stage OA include non-pharmacologic as well as pharmacologic therapy. Intra-articular injection of hyaluronic acid (HA) or platelet-rich plasma is frequently used. Disease-modifying therapies are still limited [2]. Disease progression to late-stage OA would eventually require joint replacement [3,4,5]
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