Zimmer Biomet announced positive results in PROGRESS II, a pilot study, demonstrating safety and promising efficacy from use of the nSTRIDE® Autologous Protein Solution (APS) Kit to treat knee osteoarthritis (OA).
Specifically, results indicate that the solution, which was prepared with the nSTRIDE kit, may be a viable treatment for knee OA. The process concentrates anti-inflammatory cytokines and growth factors from a patient's own blood for delivery via one intra-articular injection into the knee.
PROGRESS II was a 46-patient prospective, randomized, double-blind, saline-controlled pilot study in Europe with follow-up out to one year. Results in APS patients showed:
- A 65% change in WOMAC pain scores from baseline to 12 months vs. 41% change in the saline group
- A 49% improvement in VAS pain scores vs.13% improvement in the saline group
- No procedure- or device-related serious adverse events, with comparable frequency, severity and relatedness of adverse events compared to saline
Results from PROGRESS II led to two additional confirmatory trials:
- PROGRESS IV (NCT02905240), an FDA IDE-approved study under enrollment; saline control; slated to complete in 2019
- PROGRESS V (NCT03182374), underway in Europe to support global reimbursement efforts; comparing to Synvisc-One hyaluronic injection; slated to complete in 2023
The nSTRIDE APS Kit is not commercially available in the U.S., but is CE Marked in Europe and is marketed in Japan as the APS Kit.
Sources: Zimmer Biomet, Inc.; clinicaltrials.gov