Cryopreserved Amniotic Suspension for the Treatment of Knee Osteoarthritis
Jeremy B. Vines, MS; Antonios O. Aliprantis, MD, Ph.D.; Andreas H. Gomoll, MD, Ph.D.; Jack Farr, MD
J Knee Surg 2016; 29:443-450.
This preliminary study lacks the “power of numbers”, but begins to address the use of amniotic/placental allograft stem cells in patients, a treatment with great but unproven potential. Hopefully, much larger and more detailed studies will follow. -Kelly Cunningham MD
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.
The KOOS5 outcome score increased from a baseline of43.35 to
70.23 by the 1-year time point. The IKDC assessment
increased from an average score of 41.7 at baseline to
63.4 at 6 months. This improvement was maintained at
the 1-year time point with an average of 64.4. SANE scores30
increased from an average of 51.25 at baseline to 87.3 at
6 months. This improvement was maintained at the 1-year
time point, with an average score of 85.8. Due to the small
patient population assessed, it was determined that statistical
testing would not be appropriate for PRO data.
Disclaimer: Austin Ortho+Biologics is not affiliated with the data, content, or conclusions of this article.
