Although effectively a Phase1 trial it is randomised. Results are not so far off in the future either. Simple and well designed. It will provide definitive proof of the efficacy of ADRC in bone treatment..
Here is one other trial that gives basis for hope.
As for Epibone the whole construct with the bioreactor, cell culturing etc. makes the whole exercise economically impractical. The only positive is that they recognise the utility of ADRC ............ but we already know this .......... jus need Mayo Clinic to confirm
Although the primary outcome measures are for safety, there is an efficacy examination on the basis of MRI that is to be made at the 12 month mark.
Personally at that time I would also ask the patients a simple question.......... which leg/side do you favour when walking or upright. This should give a good indication of which side has the least/lesser pain : a very quick and easy patient self determination that can easily confirm efficacy, while waiing for the other more involved and scientific questionnaires to be underaken at 24 month mark.