"But here's the thing. It wasn't considered "unethical to conduct the two aGVHD randomised controlled clinical trials previously and given that they both failed to achieve the primary end points there is even more reason to doubt the efficacy of the treatment."
OK, re the first bit, sure they were started, but during the trial that had open ages for admission, after interim results (specifically the death rate in placebo pediatric patients) all the pediatric patients were diverted to a compassionate use study, the one that wound up with a couple of hundred entrants if I recall correctly.
And the Osiris trial also had issues with donor screening, just one of the items that would not pass muster with Mesoblast. Prior to that MSC based therapies were looking promising in Europe.
Please, try harder, too easy to put holes in the argument. I'm off to do some weeding.
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