- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00001756
Study of Mast Cell Precursors
The Characterization of CD34+ Derived Mast Cell Precursors
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892
- National Institutes of Health Clinical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
- 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 within 72 hours 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)
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Healthy Volunteers
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Patients
Patients have mast cell hyperplasia compatible with a diagnosis of systemic mastocytosis (applicable to systemic mastocytosis patients only) or other allergic, hematologic, orimmunologic condition.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Use of G-CSF administration 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 ma...
Time Frame: 12/31/2029
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Use of G-CSF administration 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 mast cells.
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12/31/2029
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Collection of CD34+ cells with or without 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 b...
Time Frame: 12/31/2029
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Collection of CD34+ cells with or without 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 contribute to these disease states.
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12/31/2029
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Collaborators and Investigators
Publications and helpful links
General Publications
- Prussin C, Lee J, Foster B. Eosinophilic gastrointestinal disease and peanut allergy are alternatively associated with IL-5+ and IL-5(-) T(H)2 responses. J Allergy Clin Immunol. 2009 Dec;124(6):1326-32.e6. doi: 10.1016/j.jaci.2009.09.048.
- Wilson TM, Maric I, Simakova O, Bai Y, Chan EC, Olivares N, Carter M, Maric D, Robyn J, Metcalfe DD. Clonal analysis of NRAS activating mutations in KIT-D816V systemic mastocytosis. Haematologica. 2011 Mar;96(3):459-63. doi: 10.3324/haematol.2010.031690. Epub 2010 Dec 6.
- Schwinger W, Mache C, Urban C, Beaufort F, Toglhofer W. Single dose of filgrastim (rhG-CSF) increases the number of hematopoietic progenitors in the peripheral blood of adult volunteers. Bone Marrow Transplant. 1993 Jun;11(6):489-92.
- Metcalfe DD. Classification and diagnosis of mastocytosis: current status. J Invest Dermatol. 1991 Mar;96(3 Suppl):2S-4S; discussion 4S, 60S-65S. doi: 10.1111/1523-1747.ep12468882.
- Falduto GH, Pfeiffer A, Zhang Q, Yin Y, Metcalfe DD, Olivera A. A Critical Function for the Transcription Factors GLI1 and GLI2 in the Proliferation and Survival of Human Mast Cells. Front Immunol. 2022 Feb 16;13:841045. doi: 10.3389/fimmu.2022.841045. eCollection 2022.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 980027
- 98-I-0027
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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