Abstract
Aims
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.
Methods
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.
Results
In all treatment groups, intra-articular injections produced a significant reduction in WOMAC-scores and weight-bearing pain (VAS). However, responses to ACS were stronger. The superiority of ACS and either HA or saline was statistically significant for all outcome measures and time points. No significant differences between HA treatment and saline injections (p>0.05, at all time points and outcome measures) were recorded. Frequency of adverse advents (AE) was comparable in the ACS- and the saline-group (p>0.05).
Conclusion
The results demonstrate that ACS is effective, long-lasting and well tolerated in the management of chronic, idiopathic OA of the knee. So far, the efficacy of ACS is defined through improvement in clinical signs and symptoms, particularly pain. It remains to be determined whether they are disease-modifying, chondroprotective, or even chondroregenerative, sequelae.
