Quote LOL, "PHASE-II COMPLETED Adipose Cells for Degenerative Disc Disease "
And a big whoop-tee doo?
1) It's OPEN LABEL, NON RANDOMIZED. That's as "weak" a study as one can conduct. Close to meaningless in its statistical results, as there's no placebo control arm, and a strong placebo effect is pretty much guaranteed as everyone knows what they got, aka OPEN LABEL.
2) TOTAL OF 15, FIFTEEN lousy people treated. Micro sized.
3) It appears that all "evaluation criteria" are very subjective and weak IMO. "visual analog scale" etc. Meaning NO MRI's, functional MRI's, CT or other scans to determine actual "re-growth" of the damaged area, etc. Just subjective patient questioning is all they seem to indicate as their "end point" criteria, as far as I read that trial description. WEAK AGAIN to me.
That size trial, having no control arm, for a non life threatening condition that has about 100 known, and generally accepted "STANDARDS OF CARE", from simple physical therapy, to chiropractic/massage, to anything from stretching and strength training to yoga, to dozens of drug based mgt methods, to surgery of all various kinds, to combo therapy plans comprising any and/or subsets of all of thee above, etc.
IMO, makes it pretty much a NON EVENT as far as I can tell.
What are they gonna be able to prove with a micro sized sample and NO BLINDED CONTROL ARM? NOT MUCH, LOL !! The statistical "powering" of the study based on the micro sample size coupled with no control arm, is for all intents and purposes non existent.
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