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Protocol Number:
08-H-0084
- Title:
Evaluation of Systemic Toxicity Associated with Allogeneic Peripheral Blood Stem Cell Infusion
- Number:
08-H-0084
- Summary:
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:
-Heart monitoring: Healthy volunteers wear a portable heart monitor, attached to the chest using four stickers, for 24 hours starting the morning of the infusion. Transplant patients wear the same device for 48 hours, starting the morning before the infusion.
-Blood draws and urine collections before, during, just after and the morning after the infusion of saline or stem cells.
-Heart ultrasound before, during or just after and the morning after the infusion.
-Peripheral artery tonometry: A small cup is placed on one finger of each hand to measure blood flow in the finger. A blood pressure cuff is inflated around the lower arm and tight pressure is maintained for about 5 minutes.
- Sponsoring Institute:
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National Heart, Lung and Blood Institute (NHLBI)
- Recruitment Detail
- Type:
Participants currently recruited/enrolled
- Gender:
Male & Female
- Referral Letter Required:
No
- Population Exclusion(s):
None
- Eligibility 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
- Special Instructions:
Currently Not Provided
- Keywords:
-
Nitric Oxide
-
Hemolysis
-
Plasma Hemoglobin
-
Dimethyl Sulfoxide
-
Organ Dysfuntion
- Recruitment Keyword(s):
-
Plasma Hemoglobin
-
Healthy Volunteer
-
HV
- Condition(s):
-
Organ Dysfunction
-
Hemolysis
- Investigational Drug(s):
- None
- Investigational Device(s):
- None
- Intervention(s):
- None
- Supporting Site:
- National Heart, Lung, and Blood Institute
- Contact(s):
-
Patient Recruitment and Public Liaison Office
Building 61 10 Cloister Court Bethesda, Maryland 20892-4754 Toll Free: 1-800-411-1222 TTY: 301-594-9774 (local),1-866-411-1010 (toll free) Fax: 301-480-9793 Electronic Mail:prpl@mail.cc.nih.gov
- Citation(s):
-
Kessinger A, Schmit-Pokorny K, Smith D, Armitage J. Cryopreservation and infusion of autologous peripheral blood stem cells. Bone Marrow Transplant. 1990 Jan;5 Suppl 1:25-7.
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Styler MJ, Topolsky DL, Crilley PA, Covalesky V, Bryan R, Bulova S, Brodsky I. Transient high grade heart block following autologous bone marrow infusion. Bone Marrow Transplant. 1992 Nov;10(5):435-8.
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Keung YK, Lau S, Elkayam U, Chen SC, Douer D. Cardiac arrhythmia after infusion of cryopreserved stem cells. Bone Marrow Transplant. 1994 Sep;14(3):363-7
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Bethesda, Maryland 20892. Last update: 01/17/2009
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