K. Kimmerling (Birmingham, US)
OrganogenesisPresenter Of 1 Presentation
24.3.7 - Treatment of Knee Osteoarthritis With Amniotic Suspension Allograft For Up to 12 Months
Abstract
Purpose
To determine the efficacy of a single intra-articular injection of amniotic suspension allograft (ASA) compared to hyaluronic acid (HA) and saline for the treatment of symptomatic knee osteoarthritis (OA).
Methods and Materials
200 subjects at 12 sites were randomized 1:1:1 to saline, HA, or ASA. Patient-reported outcomes (PROs) were collected out to 12 months. Blinded subjects who reported unacceptable pain at 3 months from saline/HA groups were eligible to cross over to the ASA arm and followed for an additional 12 months (n=95). Changes in the Visual Analog Scale (VAS) and the Knee Injury and Osteoarthritis Outcome Score (KOOS) PROs from baseline were used to evaluate efficacy of treatment.
Results
Subjects who received ASA saw a robust improvement for VAS and KOOS PROs compared to saline/HA out to 12 months (Figure 1). OMERACT-OARSI simplified responder rates following ASA treatment was 54.5% at 12 months compared to 39.1% for HA and 44.1% for saline. Subjects who crossed over and were subsequently treated with ASA saw significant improvements in VAS and KOOS PROs (p<0.05 for all) and had a 56.8% responder rate out to 12 months. Interestingly, comparison of the response of subjects who originally received ASA treatment to those who crossed over showed no significant differences in treatment effect (Figure 2).
Conclusion
Conclusions: In this 200-patient study, subjects originally randomized to ASA showed improvements in pain and function out to 12 months, while subjects who crossed over to ASA following failed treatment with saline/HA showed a robust response to ASA treatment out to 12 months. This study provides evidence supporting the use of ASA to treat symptomatic knee OA.