Interestingly, patients treated with low-dose ASCs experienced significant improvements in pain levels and function compared with baseline. Four patients experienced transient knee joint pain and swelling after local injection. After 6 months of follow-up, the procedure was found to be safe, and no serious adverse events were reported. The primary outcome parameter was safety evaluated by recording adverse events throughout the trial, and secondary parameters were pain and function subscales of the Western Ontario and McMaster Universities Arthritis Index.
The study design consisted of three consecutive cohorts (six patients each) with dose escalation: low dose (2 × 10 6 cells), medium dose (10 × 10 6), and high dose (50 × 10 6).
From April 2012 to December 2013, 18 consecutive patients with symptomatic and severe knee OA were treated with a single intra-articular injection of autologous ASCs. A bicentric, uncontrolled, open phase I clinical trial was conducted in France and Germany with regulatory agency approval for ASC expansion procedure in both countries. The present study aimed at evaluating the safety of a dose-escalation protocol of intra-articular injected adipose-derived stromal cells (ASCs) in patients with knee OA, as well as clinical efficacy as secondary endpoint. It leads to cartilage damage associated with subchondral bone changes and synovial inflammation, causing pain and disability. Osteoarthritis (OA) is the most widespread musculoskeletal disorder in adults.
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