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| Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00631787 |
Purpose
This study will try to determine what causes toxic side effects of stem cell transplantation, such as increased blood pressure, increased heart rate, decreased kidney function and abnormal heart rhythms. Stem cells are used to treat various diseases, including cancer, aplastic anemia and sickle cell disease. The cells may be given fresh to the patient or they may be preserved first with a chemical called DMSO and frozen for later use. Some stem cell transplant procedures include infusion of red blood cells along with the stem cells. This study will examine whether side effects of stem cell transplants are associated with the DMSO preservative in frozen cells or with hemoglobin (a protein released from defrosted red blood cells) or neither of these factors.
Healthy volunteers and patients scheduled to receive a stem cell transplant may be eligible for this study. Candidates must be between 10 and 80 years of age.
Transplant patients will undergo a stem cell transplant. The cells are infused through a catheter placed in a vein for the procedure. Depending on the patient's requirements, the infusion may or may not include red blood cells and may or may not contain DMSO. Healthy volunteers undergo a 4-hour saline infusion. The saline (water mixed with salt) is infused through a catheter (plastic tube) placed in a vein in the arm. In addition, all participants have the following tests and procedures:
| Condition |
|---|
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Organ Dysfunction Hemolysis |
| Study Type: | Observational |
| Study Design: | Prospective |
| Official Title: | Evaluation of Systemic Toxicity Associated With Allogeneic Peripheral Blood Stem Cell Infusion |
| Estimated Enrollment: | 36 |
| Study Start Date: | February 2008 |
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.
Eligibility| Ages Eligible for Study: | 10 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
| Contact: TTY | 1-866-411-1010 |
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
More Information
| Study ID Numbers: | 080084, 08-H-0084 |
| Study First Received: | March 7, 2008 |
| Last Updated: | January 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00631787 |
| Health Authority: | United States: Federal Government |
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Nitric Oxide Hemolysis Plasma Hemoglobin Dimethyl Sulfoxide |
Organ Dysfuntion Plasma Hemoglobin Healthy Volunteer HV |
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Nitric Oxide Dimethyl Sulfoxide Hemolysis Healthy |
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Pathologic Processes |
