S. Silva (Bologna, IT)
Rizzoli InstitutePresenter Of 1 Presentation
12.2.10 - Intra-Articular Injection of Adipose Derived-Mesenchymal Stromal Cells Versus Placebo For Bilateral Knee OA: Preliminary Results
Abstract
Purpose
Knee osteoarthritis (OA) represents a common problem with a high social impact, and a significant number of patients complain of bilateral symptomatic OA. The aim of this study was to analyze the preliminary short-term results of a double-blind randomized self-controlled trial comparing intra-articular injection of Adipose Derived-Mesenchymal Stromal Cells (ADSCs) versus placebo for bilateral knee OA.
Methods and Materials
The study design includes 100 patients with bilateral symptomatic knee OA. Each patient receives an ADSCs injection (treatment group, n=100 knees) in one knee and a saline injection (control group, n=100 knees) in the other knee. The side of the treatment is randomly assigned. Patients are prospectively followed at 1, 3, 6, 12, and 24 months assessing WOMAC, IKDC subjective and objective, EQ-VAS, and Tegner scores. MRI is performed at 12 months, and X-rays are performed with James-Duo assistance at 24 months. Up-to-date 26 patients (26 knees for each groups) were evaluated up to 6 months of follow-up and were included in the current analysis.
Results
No groups reported adverse events. In both groups two patients failed 3 months after treatment, requiring new a injective treatment. At the 6 months follow-up, a significant improvement of all clinical scores was found compared to the baseline evaluation in both groups. The WOMAC score in ADSCs and placebo groups improved from 44.3±14.0 and 45.4±13.9 to 31.9±18.2 and 27.9±20.1, (both p<0.0005) respectively. Similar trends were found for IKDC and VAS scores. No differences were observed between the two groups in terms of absolute values and improvement of the clinical scores.
Conclusion
The preliminary results of this study suggest that ADSCs did not demonstrate a clear superiority at short-term compared to placebo, reporting overall comparable results in terms of clinical scores and failures in patients with knee OA.