Clinical outcomes and safety of a combined autologous bone marrow concentrate intraosseous and intraarticular injection for knee osteoarthritis at 12 months

Objective:
Safety and therapeutic benefit were assessed for treating knee osteoarthritis with dual intraosseous (tibial plateau)and intraarticular bone marrow concentrate injections. Study participant reported outcomes for Knee Society Score Knee, Knee Society Score Function, Lower Extremity Functional Scale, and Visual Analog Scale were assessed. Outcomes at 1 year were evaluated for influence by study participant factors, including participant demographics, pre treatment clinical outcome values
and bone marrow concentrate cellular composition.
Methods:
Twent y knees with Kellgren Lawrence II III osteoarthritis were treated prospectively at a single site/single investigator in an open label pilot study with autologous bone marrow concentrate. Each participant received 80% of their bone marrow concentrate in the tibial plateau intraosseous, and 20% intraarticular. Each bone
marrow concentrate was analysed for total nucleated cells and levels of progenitor cell colony forming units by tissue culture.
Results:
No serious adverse events were associated with the trea tment. Meaningful improvement in mean clinical outcome metrics (P values: 0.0001 to 0.005) from baseline to 52 weeks was observed. Mean change in Visual Analog Scale ( 2.6) exceeded the published minimum clinically important difference of 2.5. The Lower E xtremity Functional Scale mean change was +15.8, which exceeds a published 9 point minimum clinically important difference. Influence on 52 week outcome changes for the four metrics were limited to pre treatment values, while the Knee Society Score Knee and Visual Analog Scale outcomes were influenced by a 10 fold
increase in the Total Nucleated Cell concentration.
Conclusion:
Safety was demonstrated for the bone marrow concentrate combined treatment via intraosseous and intraarticular routes f or treating Kellgren Lawrence II III knee osteoarthritis. Mean changes at 52 weeks showed substantial improvement from baseline in the outcome metrics, with Visual Analog Scale and
Lower Extremity Functional Score exceeding published minimal clinical impor tant difference values. Changes in clinical metrics were influenced by pre treatment values and Total Nucleated Cell concentration, but not other assessed patient factors