Collection of Blood From Patients With Pancytopenia - Full Text View

Sponsor:	National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:	National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:	NCT00001214

Purpose

Aplastic anemia is a condition in which the cells normally found in blood are greatly decreased. The normal levels of white blood cells, red blood cells, and platelets are much lower in patients with aplastic anemia.

Because of these low levels of blood cells, patients with aplastic anemia have a variety of immune system abnormalities. However, low levels of blood cells make it difficult to collect specialized white blood cells (mononuclear cells) for research studies.

This study was designed to collect lymphocytes from patients with low levels of all blood cells (pancytopenia) for use in research. Patients participating in the study will undergo a special procedure known as lymphapheresis. During lymphapheresis blood is taken from the patient in a manner similar to blood donation. The white blood cells are selectively removed by spinning (centrifugation), and the remaining red blood cells and platelets are placed back (re-infused) into the donor's blood stream.

Patients participating in this study will not benefit directly from it. However, cells collected in this study may increase scientific knowledge and improve understanding and treatment for diseases like aplastic anemia.

Condition
Aplastic Anemia Pancytopenia

Study Type:	Observational
Study Design:	Time Perspective: Prospective
Official Title:	Lymphocytapheresis of Patients With Pancytopenia

Resource links provided by NLM:

MedlinePlus related topics: Anemia Aplastic Anemia

U.S. FDA Resources

Further study details as provided by National Institutes of Health Clinical Center (CC):

Enrollment:	38
Study Start Date:	April 1986

Detailed Description:

Patients with aplastic anemia, myelodysplasia, and other marrow failure syndromes have a variety of immunologic abnormalities including lymphocyte phenotypic and lymphokine production dysregulation. Because of their low blood counts, it has been difficult to obtain sufficient peripheral blood mononuclear cells for research studies. Patients agreeing to this protocol will be lymphapheresed the equivalent of one or two units of cells (approximately 1-2 x 10(8) cells), which will be used for research purposes.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

INCLUSION CRITERIA:

All patients with aplastic anemia or other bone marrow failure in which we would not expect to obtain 1 X 10(8) mononuclear cells from 100 mls of peripheral blood (i.e. an absolute lymphocyte count approximately less than 2000 per mm(3)).

Age greater than or equal to 18.

EXCLUSION CRITERIA:

Patients unable to comprehend the investigational nature of the procedure.

Patients unable to tolerate a temporary reduction of blood volume the equivalent of one unit of blood.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001214

Locations

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)

More Information

Additional Information:

NIH Clinical Center Detailed Web Page This link exits the ClinicalTrials.gov site

Publications:

Zoumbos NC, Gascon P, Djeu JY, Trost SR, Young NS. Circulating activated suppressor T lymphocytes in aplastic anemia. N Engl J Med. 1985 Jan 31;312(5):257-65.

Zoumbos NC, Gascon P, Djeu JY, Young NS. Interferon is a mediator of hematopoietic suppression in aplastic anemia in vitro and possibly in vivo. Proc Natl Acad Sci U S A. 1985 Jan;82(1):188-92.

Gascon P, Zoumbos NC, Scala G, Djeu JY, Moore JG, Young NS. Lymphokine abnormalities in aplastic anemia: implications for the mechanism of action of antithymocyte globulin. Blood. 1985 Feb;65(2):407-13.

ClinicalTrials.gov Identifier:	NCT00001214 History of Changes
Other Study ID Numbers:	860088, 86-H-0088
Study First Received:	November 3, 1999
Last Updated:	December 23, 2011
Health Authority:	United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):

Bone Marrow Failure
Lymphocytapheresis
Pancytopenia
Aplastic Anemia
Hematosuppressive Disease

Additional relevant MeSH terms:

Anemia
Anemia, Aplastic
Pancytopenia
Hematologic Diseases
Bone Marrow Diseases

ClinicalTrials.gov processed this record on February 09, 2012