Evaluation of Systemic Toxicity Associated With Allogeneic Peripheral Blood Stem Cell Infusion
Allogeneic and autologous bone marrow transplantation is currently the only curative option
for many patients with life-threatening hematologic illnesses and malignancies. Peripheral
blood stem cell (PBSC) infusion has been associated with systemic toxicities including
arrhythmias, hypertension, and organ dysfunction. It has been thought that the preservative
dimethyl sulfoxide (DMSO) that is frequently used to store frozen PBSCs may be the etiology
of the adverse effects that occur during the infusion. However, we hypothesize that the red
blood cells that rupture upon thawing infused with the graft release free hemoglobin which
scavenges nitric oxide. This can lead to systemic vasoconstriction and organ dysfunction.
In this protocol, we will monitor subjects who are undergoing PBSC transplantation with
either fresh grafts that lack DMSO or frozen whole grafts. We will also evaluate patients
who receive purified stem cell grafts, which will contain negligible red blood cells and
associated free hemoglobin. We will then measure the frequency of infusion-related systemic
toxicity and organ dysfunction between the groups.
Observational
Time Perspective: Prospective
Courtney D Fitzhugh, M.D.
Principal Investigator
National Heart, Lung, and Blood Institute (NHLBI)
United States: Federal Government
080084
NCT00631787
February 2008
Name | Location |
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National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda, Maryland 20892 |