An Open-Labeled Randomized Prospective Multi-center Study to Evaluate the Efficacy and Safety of Intra-articular Injection of OSSINEXT™, an Autologous Growth Factor Concentrate (AGFC) Compared to Hyaluronic Acid (HA) in Knee Osteoarthritis.

backgroundOsteoarthritis (OA) is known as degenerative arthritis and is the second most common rheumatologic problem with a prevalence of 22%-39% in India. Knee OA (KOA) is a major cause of mobility impairment, particularly among females. Non-surgical treatment options for KOA include intra-articular injections of platelet-rich plasma (PRP) and hyaluronic acid (HA). Most commercially available PRP preparation kits do not remove RBCs and WBCs which are detrimental to the healing effects. Wockhardt Regenerative Pvt. Ltd., Mumbai, India has developed a kit known as Ossinext™ which has an advantage over traditional PRP in that it eliminates RBCs and WBCs. This study was conducted to evaluate the effectiveness and safety of intra-articular injection of Wockhardt's Ossinext™ an autologous growth factor concentrate (AGFC) versus HA in KOA.

methodsMale and female patients in the age group between 30 and 75 years with confirmed KOA on radiological assessment with Grades I-III on the Kellgren-Lawrence Grading Scale and with visual analog scale (VAS) pain score of 4 or more (on the numeric rating scale) in spite of taking non-steroidal anti-inflammatory drugs (NSAIDs) since past 2 weeks were considered for study participation. This was an open-labeled study and eligible patients were randomly allocated to AGFC or HA in a 1:1 fashion. Three intra-articular injections were given in the affected knee joint, i.e. at baseline, month 1, and month 2 visits. Patients were evaluated at regular intervals, i.e. at months 5, 8, and 11 for primary and secondary endpoints. The primary efficacy endpoint for this study was change from baseline in WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) scores at month 11 whereas the secondary efficacy endpoints were change from baseline of VAS pain scale at months 1, 2, 5, 8, and 11 as well as change from baseline of WOMAC, KOOS (Knee and Osteoarthritis Outcome System), and IKDC (International Knee Documentation Committee) scale at month 5, 8, and 11. For analysis a mixed model for repeated measures was used.

resultsOut of the 100 patients who were enrolled, 50 patients each were randomized to AGFC and HA arm. The results were analyzed from 99 patients (49 for AGFC and 50 for HA) who met the criteria for the modified intent to treat (mITT) population. At month 11 on the WOMAC scale, there was greater improvement seen with Ossinext™ compared to HA group which was also statistically significant with p-value of 0.0332. Within the group, there was statistically significant improvement before and after treatment in all scales, i.e. WOMAC, KOOS, IKDC, and VAS at all time points, i.e. months 5, 8, and 11 with a p-value as low as <0.0001. Within the group, the VAS score showed statistically significant improvement even at months 1 and 2 as well. A total of 24 patients reported 37 adverse events (AEs) during the study, most common being pain, pyrexia and swelling but none of the AEs reported during the study were considered as severe in intensity. There were no safety concerns reported.

conclusionsIn conclusion, greater and statistically significant improvement was seen with Ossinext™ in WOMAC scores at month 11 compared to HA. Ossinext™ also showed marked statistically significant improvement from before treatment to after treatment in the WOMAC, KOOS, IKDC, and VAS scales used for the assessment of KOA with a p-value as low as <0.0001. Ossinext™ was also safe and well-tolerated.