IMO the next 12 month trial will try to simulate as close as possible the previous successful Phase III trial to elicit similar results with Pain Reduction and Opioid Sparing Effects. That would be the smart play as the FDA have essentially given us a ticket to approval if can replicate results. I am expecting we will have similar statistically significant and meaningful results if done to replicate.
Personally I would not be game, but maybe they will consider tightening scope to treating earlier in disease process or add some sort of biomarker criteria if have data on this? At this stage I would definitely not be changing the placebo or treatment arms. Now we have a 12 month trial pathway to approval it
would not be wise to run a trial with a comparison arm for the primary reasons: 1. not necessary to do so for approval, 2. would take longer and more expensive, 3. possibility of needing to replicate those results with another follow up trial etc.
I suspect the doc would like to see a comparitor arm to prove in his mind it is the cells that work. If you look at the Phase III results we can clearly see the cells work over placebo injection. Also the physicians would know from real world experience that in the combination Rex-L and HA it would be Rex-L doing the heavy lifting. Plus other reasons a comparitor arm is not wise IMO:
* HA - 1. not standard of care therefore not necessary; 2. May even be synergistic with Rex-L (like Rem-L may be synergistic with DEXA for COVID ARDS); 3. As other posters pointed out yesterday Rex-L found to be superior to HA in Phase II trial if I understood correctly.
* Cortisone Injections - A great benefit for Rex-L vs Cortisone Injections IMO is the longer duration of pain reduction (and potential to halt disease progression - versus the so called band aid approach to treatment with Cortisone) and much improved safety profile (too frequent cortisone injections are problematic and not recommended). Little point comparing these therapies over a shorter period.
* Obviously it would be inappropriate to randomise one group to Rex-L and another to Opioids (guess that is a certainty).
Having said this I would be curious to compare Rex-L with Platelet-rich plasma therapy (at least we would be comparing two cell therapies). FYI Platelet-rich plasma therapy uses injections of a patients own platelets to accelerate the healing of injured tendons, joints, muscles etc. However this would not be an off the shelf product like Rex-L (win for us), and may only last for 6 - 9 months (win for us too). Also I would suspect Rex-L would have a superior and more consistent anti-inflammatory/healing effect (I would just pick this other cell therapy as a comparitor out of my own curiosity;
let me be clear this is just out of curiosity - not necessary nor practical).
Looking forward to partnering up with a multinational in this space (ex-EU of course) for Rex-L for CLBP and future osteo indications. Not long now given the positive pathway to approval one would hope. A market-sensitive announcement for sure
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