A short report on the effect of decreased incubation time on the architectural profile of autologous conditioned serum (ACS).

If present in high enough concentrations, IL-1-Ra has the potential to inhibit Interleukin-1, the chief offender that promotes the pro-inflammatory cascade causing pain, swelling and joint dysfunction associated with osteoarthritis (OA). IL-1-Ra and growth factor levels were quantified from whole blood in this retrospective chart review investigation (n=20) using Zero and 15min incubation times respectively. The hypothesis that this process can significantly (p<0.0001) increase levels of IL-1-Ra was confirmed. Mean Arthrokinex™ induced IL-1-Ra levels reached a concentration of 13,288pg/mL and 12,809pg/mL compared to 518pg/mL at baseline, representing a 26-fold increase. Post conditioning levels of pro-inflammatories IL-1ß, IL-6 and TNF α were not changed to any significant degree. The Arthrokinex™ blood conditioning process induces adequate levels of IL-1-Ra to alter the IL-1-Ra: IL-1ß ratio and mitigate the inflammatory cascade, while increasing growth factors PDGF and TGF respectively.

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-1ß. 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.

A method to induce Interleukin-1 Receptor Antagonist Protein from autologous whole blood.

OBJECTIVE: Current orthopedic therapies, aimed solely at symptomatic control, are unable to restore the cytokine imbalance that produces the hallmark clinical profile of osteoarthritis. While a myriad of chemical factors in the cytokine network stimulate local joint inflammation and pain, Interleukin 1 (IL-1) is widely recognized as a key offender and a potential therapeutic target. The purpose of this article is to describe a novel, on-site, point of service process (Arthrokinex™) to induce Interleukin 1 Receptor Antagonist Protein (IL-1-Ra or IRAP) from whole blood aimed at inhibiting the destructive intra-articular effects of IL-1. METHODS: 53 patient charts were included in this retrospective chart review study. Venous blood from the selected participants had been harvested and centrifuged to isolate Platelet Rich Plasma and Platelet Poor Plasma. These layers were extracted and incubated for 30 min in a specialized syringe containing medical grade concentrator beads. After centrifuge filtration, the supernatant containing IL-1-Ra was extracted. Anti-inflammatory (IL-1-Ra, IL-10) and pro-inflammatory (TNF α, IL-1 ß) cytokines of baseline whole blood were compared to the conditioned serum following quantification using ELISA. RESULTS: On average, a 32-fold increase (baseline, 550 pg/mL; post conditioning 17,537 pg/mL) in IL-1-Ra concentration was observed after the brief interaction of blood with the concentrator bead surface. IL-1-Ra, if present in concentrations that are 10-100 times higher than IL-1ß, will block the interaction of IL-1ß with cell surface receptors. At these increased concentrations, Arthrokinex™ induced IL-1-Ra joint injections produce an IL-1-Ra to IL-1ß ratio of 999:1. Post conditioning levels of IL-1ß and TNF α were not clinically significant. CONCLUSION: The Arthrokinex™ blood conditioning process has the ability to rapidly induce IL-1-Ra without increasing the pro-inflammatory cytokine profile.

An exploratory trial of Cyclamen europaeum extract for acute rhinosinusitis.

OBJECTIVES/HYPOTHESIS: An exploratory US trial in patients with acute rhinosinusitis was conducted to evaluate the efficacy and safety of Cyclamen europeaum extract, a product marketed in Europe that causes reflex nasal discharge and subsequent decongestion. STUDY DESIGN: Prospective, randomized, placebo-controlled, double-blind, and parallel group. METHODS: Outpatients (n = 29) with cardinal symptoms of acute rhinosinusitis and both endoscopic and radiographic (computed tomography [CT] scan) evidence at 25 US centers were randomized to receive intranasal, lyophilized, reconstituted Cyclamen europeaum extract (Cyclamen) or placebo spray for 7 days. Primary outcomes were reduction in percent sinus opacification on CT scans and reduction in PM predose instantaneous total symptom scores measured on a six-point scale. Secondary outcomes included other measures of symptom score change and endoscopic signs of mucopurulence and inflammation. RESULTS: Cyclamen treatment significantly reduced sinus opacification compared with placebo treatment (P < .045). Although Cyclamen treatment reduced total symptom scores from baseline more than placebo treatment (-2.4 vs. -1.4), there were no significant treatment group differences (P = .312). Cyclamen treatment was well tolerated. CONCLUSIONS: Cyclamen treatment significantly reduced sinus opacification in patients with acute rhinosinusitis. Further exploration of Cyclamen treatment in larger patient populations is warranted.