This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Evaluation of Toxicity From Stem Cell Transplant

This study has been completed.
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) ) Identifier:
First received: March 7, 2008
Last updated: June 30, 2017
Last verified: December 7, 2015

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.

Organ Dysfunction Hemolysis

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Evaluation of Systemic Toxicity Associated With Allogeneic Peripheral Blood Stem Cell Infusion

Further study details as provided by National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) ):

Enrollment: 61
Study Start Date: February 29, 2008
Estimated Study Completion Date: December 7, 2015
Detailed Description:
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.

Ages Eligible for Study:   10 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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


Ages 10-80

Otherwise as stated on the subject s primary protocol


History of clinically significant cardiac or pulmonary disease


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00631787

United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Courtney D Fitzhugh, M.D. National Heart, Lung, and Blood Institute (NHLBI)
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: National Heart, Lung, and Blood Institute (NHLBI) Identifier: NCT00631787     History of Changes
Other Study ID Numbers: 080084
Study First Received: March 7, 2008
Last Updated: June 30, 2017

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) ):
Nitric Oxide
Plasma Hemoglobin
Dimethyl Sulfoxide
Organ Dysfuntion
Healthy Volunteer

Additional relevant MeSH terms:
Pathologic Processes processed this record on September 19, 2017