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Evaluation of Systemic Toxicity Associated With Allogeneic Peripheral Blood Stem Cell Infusion


N/A
10 Years
80 Years
Not Enrolling
Both
Organ Dysfunction, Hemolysis

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Trial Information

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.

Inclusion Criteria


- INCLUSION CRITERIA HEALTHY VOLUNTEERS:

Ages 10 to 80

Normal renal function: creatinine less than 1.5 mg/dL in subjects greater than or equal to
18 years of age, less than or equal to 1.0 mg/dL in subjects 13 to 17 years of age, less
than or equal to 0.7 in subjects 10 to 12 years of age, and proteinuria less than 1+

Normal liver function: bilirubin less than 1.5 mg/dL and transaminases within normal
limits

Normal pulmonary arterial pressure by transthoracic echocardiogram (tricuspid regurgitant
velocity less than 2.5 m/s)

Ability to comprehend and willing to sign an informed consent/assent

INCLUSION CRITERIA ALL OTHERS:

Ages 10-80

Otherwise as stated on the subject's primary protocol

EXCLUSION CRITERIA HEALTHY VOLUNTEERS:

History of clinically significant cardiac or pulmonary disease

EXCLUSION CRITERIA ALL OTHERS:

Patients receiving nitrate antihypertensive medications

Clinically unstable patients in which transfer to the intensive care unit is being
considered

Otherwise as stated on the subject's primary protocol

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Principal Investigator

Courtney D Fitzhugh, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Heart, Lung, and Blood Institute (NHLBI)

Authority:

United States: Federal Government

Study ID:

080084

NCT ID:

NCT00631787

Start Date:

February 2008

Completion Date:

Related Keywords:

  • Organ Dysfunction
  • Hemolysis
  • Nitric Oxide
  • Hemolysis
  • Plasma Hemoglobin
  • Dimethyl Sulfoxide
  • Organ Dysfuntion
  • Healthy Volunteer
  • HV
  • Hemolysis

Name

Location

National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, Maryland  20892