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Collection of Blood From Patients With Pancytopenia

This study is currently recruiting participants.
Study NCT00001214.   Last updated on July 18, 2008.   Information provided by National Institutes of Health Clinical Center (CC)

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Descriptive Information Fields
Brief Title  Collection of Blood From Patients With Pancytopenia
Official Title  Lymphocytapheresis of Patients With Pancytopenia
Brief Summary

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.

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.

Study Phase
Study Type  Observational
Study Design  Prospective
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Aplastic Anemia
Pancytopenia
Intervention 
MEDLINE PMIDs 2981406,   3918301,   2981588
Links NIH Clinical Center Detailed Web Page This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  40
Start Date  April 1986
Completion Date
Eligibility 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 18 or older.

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.

Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Contact: Patient Recruitment and Public Liaison Office     (800) 411-1222     prpl@mail.cc.nih.gov    
Contact: TTY     1-866-411-1010        
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00001214
Organization ID 860088
Secondary IDs †† 86-H-0088
Study Sponsor  National Heart, Lung, and Blood Institute (NHLBI)
Collaborators ††
Investigators 
Information Provided By National Institutes of Health Clinical Center (CC)
Verification Date January 2008
First Received Date  November 3, 1999
Last Updated Date July 18, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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