Evaluation of Toxicity From Stem Cell Transplant

NCT00631787 | Completed

• 2 other identifiers: 08008408-H-0084
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Organ Dysfunction; Hemolysis

Keywords

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

Eligibility Criteria

• Age: 10 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (4)

• 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.

  PMID: 1969303 BACKGROUND

• 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.

  PMID: 1464006 BACKGROUND

• 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.

  PMID: 7994256 BACKGROUND

• 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.

  PMID: 22547579 DERIVED

MeSH Terms

Conditions

Hemolysis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Courtney D Fitzhugh, M.D.

  National Heart, Lung, and Blood Institute (NHLBI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2008
• First Posted: March 10, 2008
• Study Start: February 29, 2008
• Study Completion: December 7, 2015
• Last Updated: June 17, 2019

Record last verified: 2015-12-07

Locations

US (1)