- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00631787
Evaluation of Toxicity From Stem Cell Transplant
Evaluation of Systemic Toxicity Associated With Allogeneic Peripheral Blood Stem Cell Infusion
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
- 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
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Publications and helpful links
General Publications
- 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. No abstract available.
- 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.
- 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.
- Fitzhugh CD, Unno H, Hathaway V, Coles WA, Link ME, Weitzel RP, Zhao X, Wright EC, Stroncek DF, Kato GJ, Hsieh MM, Tisdale JF. Infusion of hemolyzed red blood cells within peripheral blood stem cell grafts in patients with and without sickle cell disease. Blood. 2012 Jun 14;119(24):5671-3. doi: 10.1182/blood-2011-11-392654. Epub 2012 Apr 30.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 080084
- 08-H-0084
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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