Search / Trial NCT00001756

Study of Mast Cell Precursors

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Nov 3, 1999

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Trial Information

Current as of July 14, 2024

Completed

Keywords

Leukapheresis Mastocytosis Mast Cells Normal Volunteer Natural History Systemic Mastocytosis

Description

The purpose of this protocol is to obtain large numbers of CD34+ cells from the peripheral blood of healthy volunteers and patients with systemic mastocytosis or other related allergic, hematological, and immunological conditions by leukapheresis for culture and characterization of mast cell progenitor cells and their response to various cytokines and anti-mitotic agents. Healthy volunteers and patients will be adults of both sexes from 18 to 70 years of age. Granulocyte colony stimulating factor (G-CSF) will be administered to healthy volunteers at dose of 10 mcg/kg/day as a subcutaneous d...

Gender

All

Eligibility criteria

  • 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)

Attachments

readout_NCT00001756_2024-07-14.pdf

4.5 MB

NCT00001756_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Bethesda, Maryland, United States

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

12/31/2029

Reviews (48)

4.6

All reviews come from applied patients

5 stars
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4 stars
6
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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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