Abstract
There are few treatment options for symptomatic knee osteoarthritis (OA). Human amniotic
suspension allografts (ASA) have anti-inflammatory and chondroregenerative potential
and thus represent a promising treatment strategy. In anticipation of a large, placebo-controlled
trial of intra-articular ASA for symptomatic knee OA, an open-label prospective feasibility
study was performed. Six patients with Kellgren–Lawrence grades 3 and 4 tibiofemoral
knee OA were administered a single intra-articular ASA injection containing cryopreserved
particulated human amnion and amniotic fluid cells. Patients were followed for 12
months after treatment. No significant injection reactions were noted. Compared with
baseline there were (1) no significant effect of the ASA injection on blood cell counts,
lymphocyte subsets, or inflammatory markers and (2) a small, but statistically significant
increase in serum IgG and IgE levels. Patient-reported outcomes including International
Knee Documentation Committee, Knee Injury and Osteoarthritis Outcome, and Single Assessment
Numeric Evaluation scores were collected throughout the study and evaluated for up
to 12 months. Overall, this study demonstrates the feasibility of a single intra-articular
injection of ASA for the treatment of knee OA and provides the foundation for a large
placebo-controlled trial of intra-articular ASA for symptomatic knee OA.
Keywords
osteoarthritis - viscosupplementation - amnion - stem cells - allograft
