Chronic Lower Back Pain - the sleeping giant., page-146

HA acts as a carrier that enhances the migratory effects of cells towards the site of inflammation. FDA clear HA is not the active agent. HA is an experimental agent (has not been approved) so unethical to include in any trial as control group.

Re MAO: Additional imaging tools (dyes/agents) to validate and measure change in metabolic activity are now available that were not previously in previous trial - will go to inform overall assessment plus a number of biomarkers. Interesting indeed.

The physician wished he had an ongoing trial at present because wants to give patients access to Rex-L. Speaks volumes.

Future trial to include roughly same patient population as previous phase III - confident of statistical significance with these numbers. Trial proposed to start later this year or earlier next year.

A disease of the young. Increasing due to sports injuries and obesity. Much less time commitment (in and out day procedure) vs traditional non-invasive (e.g. chiro etc) and surgery. Fusion surgery in lumbar area is associated with predictable adjacent segment disease, leading to operation after operation. Plus surgery only reduces pain by 1/3. Not a good present outcome.

This will create wholesale changes to how we treat. Not any durable treatment alternatives (and ones with evidence) for CLBP due to DDD. Huge market for this one!!!