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
|
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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 |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
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 ]

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
- SUBJECT INCLUSION CRITERIA:
Healthy Volunteers must:
- Be 18-70 years of age
- Be healthy
- Have adequate peripheral venous access
- Have normal renal function (creatinine less than or equal to 1.5mg/dL; less than or equal to 1 plus proteinuria)
- Have normal hepatic function (bilirubin less than or equal to 1.5 mg/dL)
- Have normal hematologic function (WBC greater than or equal to 3000/mm(3); granulocytes greater than or equal to 1500/mm(3) ; platelets greater than or equal to 175,000; hemoglobin greater than or equal to 12.5 g/dL)
Patients must:
- Be 18-70 years of age
- Have mast cell hyperplasia compatible with a diagnosis of systemic mastocytosis (applicable to systemic mastocytosis patients only) or other allergic, hematologic, or immunologic condition
- Have adequate peripheral venous access or be willing to have a central line placed.
- First be admitted as inpatients under an existing NIH protocol
- Have preserved renal function (creatinine less than or equal to 2 mg/dL; less than or equal to 2 plus proteinuria)
- Have preserved hepatic function (bilirubin less than or equal to 1.5 mg/dL)
- Have preserved hematologic function (WBC greater than or equal to 3000/mm(3); granulocytes greater than or equal to 1500/mm(3) ; platelets greater than or equal to 175,000; hemoglobin greater than or equal to 12.5 g/dL)
All female subjects of childbearing potential:
- May be enrolled if using effective contraception
- Have a negative serum or urine pregnancy test determined before beginning Plerixafor or G-CSF administration
SUBJECT EXCLUSION CRITERIA:
All subjects must not meet any of the following criteria:
Healthy volunteers and patients must not:
- Have active bacterial, fungal or viral infections
- Have viral screens positive for HIV or hepatitis B or C
- Be pregnant or lactating
- Have a history of autoimmune disease such as rheumatoid arthritis, vasculitis, pyoderma gangrenosum or similar disorder
- Have any condition, which in the judgment of the investigator, might place the subject at undue risk
Healthy Volunteers with any of the following will be excluded:
- Splenomegaly, pulmonary fibrosis and other related conditions
- Use of any investigative drugs within the past 12 months
- Have a significant coagulation disorder
Systemic Mastocytosis and Mast Cell Related Condition Patients with any of the following will be excluded:
- Patients taking any other growth factors, cytokines or investigative drugs
- Patients who are hemodynamically unstable (blood pressure systolic of lower than 105 or diastolic lower than 65)

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) 443-1720 | eischar@mail.nih.gov | |
Contact: Hirsh D Komarow, M.D. | (301) 594-2197 | komarowh@mail.nih.gov |
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 prpl@cc.nih.gov |
Principal Investigator: | Hirsh D Komarow, M.D. | National Institute of Allergy and Infectious Diseases (NIAID) |
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00001756 History of Changes |
Other Study ID Numbers: |
980027 98-I-0027 |
First Posted: | November 4, 1999 Key Record Dates |
Last Update Posted: | March 29, 2018 |
Last Verified: | August 8, 2017 |
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ):
Leukapheresis Mastocytosis G-CSF |
Mast Cells Normal Volunteer Systemic Mastocytosis |
Additional relevant MeSH terms:
Mastocytosis Mastocytosis, Systemic Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms |
Skin Diseases Lenograstim Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs |