Study of Mast Cell Precursors
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|ClinicalTrials.gov Identifier: NCT00001756|
Recruitment Status : Recruiting
First Posted : November 4, 1999
Last Update Posted : March 29, 2018
This study will investigate mast cell precursors that circulate in the blood. In a group of diseases collectively known as mastocytosis, mast cells accumulate in abnormal amounts in the skin, lymphoid tissues, bone marrow, liver and spleen. Some forms of mastocytosis have a generally good prognosis; for others, the prognosis is poorer. There is no known cure for any form of the disease. A better understanding of mast cells and how they respond to certain substances may provide insights that will lead to effective treatments for mastocytosis.
Patients with systemic mastocytosis and normal healthy volunteers between the ages of 20 and 60 may be eligible for this 8-day study. Participants will undergo the following procedures:
- Day 1 Medical history, physical examination, and blood tests to assess general health status
- Days 2 through 6 Daily injections under the skin of G-CSF a hormone that stimulates white blood cell production
- Day 7 Leukapheresis a procedure for collecting large numbers of white blood cells. In leukapheresis, blood is drawn through a needle placed in an arm and channeled into a cell separator machine. The white cells are collected and the rest of the blood is returned to the body through a needle in the other arm. The procedure takes up to 3 hours.
- Days 7 and 8 Blood draw (about 1 teaspoon) to monitor white blood cell counts.
|Condition or disease|
|Normal Physiology Systemic Mastocytosis|
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||The Characterization of CD34+ Derived Mast Cell Precursors Mobilized by Administration of Granulocyte Colony Stimulating Factor and Plerixafor|
|Study Start Date :||November 12, 1997|
- 1. Use of G-CSF administration in healthy volunteers to mobilize and enhance CD34+ hematopoietic progenitor cell numbers into the peripheral blood in order to culture and characterize human mast cells, study and characterize CD34+ -derived human... [ Time Frame: Ongoing ]
- 2. Use of Plerixafor administration in patients with systemic mastocytosis and other related allergic, hematological and immunological conditions to mobilize and enhance CD34+ cells into the peripheral blood to culture and learn how mast cells c... [ Time Frame: Ongoing ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001756
|Contact: Robin R. Eisch, R.N.||(301) firstname.lastname@example.org|
|Contact: Hirsh D Komarow, M.D.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||Hirsh D Komarow, M.D.||National Institute of Allergy and Infectious Diseases (NIAID)|