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Positive results seen with autologous protein solution kit for treatment of knee OA
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Zimmer Biomet Holdings Inc. announced that researchers of a pilot study have published positive results that demonstrate the nStride autologous protein solution kit as safe and efficacious for the treatment of knee osteoarthritis.
According to a press release, investigators from the PROGRESS II trial prepared the autologous protein solution (APS) with the nStride kit, which concentrated inflammatory cytokines and growth factors from a sample of blood for the patient. The patients then receive the solution via a single intraarticular injection into the knee joint.
“A key difference between nStride APS and [platelet-rich plasma (PRP)] is the high content of leukocytes and associated anti-inflammatory cytokines,” Elizaveta Kon, MD, associated professor of Humanitas University, chief of Translational Orthopedics Unit, Knee Functional and Biological Reconstruction Center at Humanitas Research Hospital, Milan Italy, told Healio.com/Orthopedics. “Leukocytes in PRP are frequently accused to create pro-inflammatory factors, but it is not always true. Characterization of APS in the study reflected a high concentration of anti-inflammatory cytokines and low concentration of their inflammatory counterparts.”
She added, “APS nStride is not leukocyte-rich PRP. It is a completely different product focused on the concentration of anti-inflammatory cytokines, so the results of the study do not correlate with the leukocyte-rich PRP in vitro and clinical studies results. This trial is very important for the confirmation of nStride safety and efficacy and open the gate for the big randomized controlled trial comparing [nStride] to hyaluronic acid , actually in progress.”
Researchers had performed a prospective, randomized, double-blind, saline controlled pilot study with 46 patients with knee OA pain from four sites across Europe. Overall, 31 patients received nStride APS and 15 patients received a single saline injection. At 2 weeks, 1 months, 3 months, 6 months and 12 months post-injection, investigators assessed patients for patient-reported outcomes and adverse events. They use visual analogue scale (VAS), WOMAC and KOOS to measure clinical effectiveness. At baseline, 3 months and 12 months after treatment, they conducted X-ray and MRI evaluations.
Results showed patients treated with nStride APS had a 65% change in WOMAC score from baseline to 12 months vs. 41% in patients treated with the saline solution. Additionally, there was a 49% improvement in VAS pain scores in patients treated with the APS vs. those treated with saline. Patients treated with the APS had no procedure or device-related serious adverse events.
The nStride kit is not available commercially in the United States; however, it received CE mark approval in Europe, and in Japan it is marketed as the APS kit.
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