Accession Number:

AD1024510

Title:

The Use of Novel Therapies to Reconstitute Blood Cell Production and Promote Organ Performance, Using Bone Marrow Failure as a Model

Descriptive Note:

Technical Report,28 Sep 2013,27 Sep 2014

Corporate Author:

The Feinstein Institute for Medical Research Manhasset United States

Personal Author(s):

Report Date:

2014-10-01

Pagination or Media Count:

8.0

Abstract:

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 During this report year 27 subjects were consented 20 were enrolled 6 were deemed screen failures, and 1 was withdrawn prior to enrollment.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.

Subject Categories:

  • Medicine and Medical Research

Distribution Statement:

APPROVED FOR PUBLIC RELEASE