A new treatment for knee osteoarthritis: Clinical evidence for the efficacy of Arthrokinex™ autologous conditioned serum.

OBJECTIVE: The desired therapeutic effect of Arthrokinex™ autologous conditioned serum (ACS) is facilitated by the ability of IL-1-Ra to limit the destructive inflammatory intra-articular (IA) actions of IL-1β. Previous studies have proven the capacity of Arthrokinex™ (ACS) to induce the anti-inflammatory cytokine, IL-1-Ra. The primary purpose of this retrospective study was to investigate the effect of Arthrokinex™ (ACS) to reduce pain, improve joint function and enhance quality of life in patients with knee osteoarthritis.

METHODS: Venous blood from 100 patients with symptomatic knee osteoarthritis (KOA) was conditioned and injected into the affected joint in this treatment protocol. Each patient received a total of six ultrasound-guided IA injections at day 0, 7, 14, 90, 180, and 270 and followed for up to one year. Treatment outcome measures were assessed by three different patient-administered surveys at each visit. Using the Visual Analog Pain Scale (VAS), participants were asked to classify pain in the previous 24 h. The Extra Short Musculoskeletal Functional Assessment (XSMFA-D) survey is a series of 16 questions designed to determine the functionality of the OA-affected joint. Finally, the patient completed a patient global impression of change (PGIC) survey to assess their individual level of satisfaction with the treatment regimen.

RESULTS: Compared to baseline, a total of 84% of patients reported better pain control at 6 months with 91% reporting improvement at 12 months. A robust and statistically significant improvement in each XSMFA-D subscale was observed in KOA patients over 12 months. The overall reduction of pain and enhanced joint function was observed within 1 week and sustained 3, 6 and even 12 months after the initial injection. In addition to symptomatic control of OA, 92% of patients reported satisfaction with the treatment regimen 12 months after the initial injection.

CONCLUSION: Given the favorable safety profile, reduction in pain and enhanced quality of life experienced by patients enrolled in this joint health program, Arthrokinex™ (ACS) has the potential to offer an alternative, chondroprotective, natural, molecular approach to treating pain and functionality in patients with mild, moderate or severe knee osteoarthritis.