Accession Number:

AD1024511

Title:

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

Descriptive Note:

Technical Report,28 Sep 2014,27 Sep 2015

Corporate Author:

FEINSTEIN INST FOR MEDICAL RESEARCH MANHASSET NY MANHASSET United States

Personal Author(s):

Report Date:

2015-10-01

Pagination or Media Count:

15.0

Abstract:

This protocol has been accruing subjects appropriately and will close to accrual soon. During this report year 13subjects were consented 13 were screened and, 1 was deemed a screen failure. Two subjects 11-002 and 12-1 were withdrawn from the study one by the local Pl the center could not obtain records needed for screening from the referring institution and one by the central site Pl the subject was reported to be on Zenpep for gastrointestinal absorption issues and there are no data on the absorption of Leucine in this setting. There was one severe adverse event reported in subject 02-005 the subject had an anaphylactic reaction to a blood transfusion 33 minutes from the start of the transfusion and was no deemed associated with the study drug. The subject was admitted for observation and was discharged the following day without any further issues.

Subject Categories:

Distribution Statement:

APPROVED FOR PUBLIC RELEASE