A new therapy, based on the intra-articular injection of autologous conditioned serum (ACS), is used in several European countries for osteoarthritis (OA) treatment. ACS is generated by incubating venous blood with medical grade glass beads. Peripheral blood leukocytes produce elevated amounts of endogenous anti-inflammatory cytokines such as interleukin-1 receptor antagonist (IL-1Ra) and growth factors that are recovered in the serum(1). ACS has been shown to improve the clinical lameness in horses significantly to enhance the healing of muscle injuries in animal models, and in human athletes. In the present study, the efficacy and safety of ACS was compared to intra-articular hyaluronan (HA), and saline in patients with confirmed knee OA. In a prospective, randomised, patient- and observer-blind trial with three parallel groups, 376 patients with knee OA were included in an intention to treat (ITT-) analysis. Efficacy was assessed by patient-administered outcome instruments (WOMAC, VAS, SF-8, GPA) after 7, 13 and 26 weeks (blinded) and Two-years (non-blinded). The frequency and severity of adverse events were used as safety parameters.Aims
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