The Use of Novel Therapies to Reconstitute Blood Cell Production and Promote Organ Performance, Using Bone Marrow Failure as a Model
Technical Report,28 Sep 2013,27 Sep 2014
The Feinstein Institute for Medical Research Manhasset United States
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This protocol has been accruing subjects appropriately. During this report year 27 subjects were consented 20 were enrolled 6 were deemed screen failures, and 1 was withdrawn prior to enrollment. Of the 6 screen failures, 1 subject was found to have taken leucine over-the-counter 1 was not chronically transfusion dependent as per the criteria of the study 1 had a history of severe non-compliance 1 had elevated liver function tests beyond the limits allowed on the study 1 was found to be on Prednisone on review and 1 was being treated for pancreatic insufficiency and was deemed ineligible as the absorption of the study drug with pancreatic enzyme replacement is known. Three subjects 02-003, 02-004, and 02-005 required re-consenting as their enrollment did not occur within 30 days of the signing of the original consent.
- Medicine and Medical Research