Incorrect. Pre-clinical trials have concluded with the corresponding data reflecting the required efficacy and safety for human trials complete.
Given that historical data from similar treatments exercising the same method for cell retrieval has shown to be successful and with minimal side effects in human subjects, there is no reason why the FDA will not approve the HemXellerate process for clinical trials in the very near future.
With Orphan Drug status and an increased pressure on the FDA by various cancer research groups to allow for fast tracked personalized treatment approaches, HemaXellerate is poised to go from IND application submission to completion of clinical trials in no time, comparatively speaking.
Since this treatment does not consist of a method that pumps chemicals into a patient that may or may not ultimately create toxic effects rather utilizes a process that encourages the patients own cells to fight against the disease through proliferation, this treatment very much stands out above the rest and demands the full consideration and cooperation of those charged with seeing it made available to the public.
BMSN!