Collection of Blood From Patients With Pancytopenia

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.

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Key information

Conditions

Pancytopenia Anemia Anemia, Aplastic Bone Marrow Diseases Bone Marrow Failure Disorders Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Goal was to obtain adequate numbers of cells for laboratory studies from pancytopenic patients in whom simple phlebotomy is inadequate.

Time frame: 1 day

To obtain enough cells if phlebotomy inadequate.

Sponsors and collaborators

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Nih

Registry information

Official study title

Lymphocytapheresis of Patients With Pancytopenia

Important dates

Study start: 1986
Primary completion: 2009
Study completion: 2020
First posted: Nov 4, 1999
Registry last updated: Aug 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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