The new bioactive cell-free formulation- BIOF2, has been proved to be well-tolerated, more economical and employ more straightforward technique than arthroplasty as explained in this clinical trial. It had a success rate that portrayed no statistically significant difference from that of arthroplasty for the treatment of severe knee osteoarthritis. Articular cartilage regeneration was a probable reason for success. 

For articular cartilage regeneration, a promising novel cell-free bioactive formulation BIOF2 has undergone preclinical trials. This study aimed to assess the efficacy and safety of BIOF2 for articular cartilage regeneration in OA patients.

Total 24 patients with severe osteoarthritis were included in the study, which was further divided into three groups of 8 patients each. All the patients had their osteoarthritis in control by the use of NSAIDs. Group 1, 2, and 3 were treated respectively with intra-articular BIOF2, total joint arthroplasty and conservative treatment with NSAIDs alone. The evaluation of WOMAC score, RAPID3 and Rasmussen clinical score was done before treatment and at month 3, 6 and 12. At 0,3 and 6 months, BIOF2 was applied. In BIOF2 group, complete blood count, blood chemistry and articular cartilage volume were evaluated at different time points.

At month 3, arthroplasty and BIOF2 treatments showed improvements in different scores compared to NSAIDs group. WOMAC score of arthroplasty group and BIOF2 group were not very significantly different at month 6. At month 12, 75% of patients showed high recovery in arthroplasty and BIOF2 groups with reduced usage of NSAIDs. Articular cartilage was increased by 22%, and serum lipids were decreased by BIOF2 treatment. Upon BIOF2 application, a slight pain was caused with overall good tolerance.

BIOF2, which is a new bioactive cell-free formulation, showed similar effectiveness in severe osteoarthritis knee treatment to that of arthroplasty. Articular cartilage regeneration rate was reported to be high with BIOF2, and it proved to be well-tolerated and efficient alternative therapy for knee OA treatment.