NIH Clinical Research Studies

Protocol Number: 98-I-0027

Active Accrual, Protocols Recruiting New Patients

Title:
The Characterization of CD34+ Derived Mast Cell Precursors Mobilized by Administration of Granulocyte Colony Stimulating Factor
Number:
98-I-0027
Summary:
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.

Sponsoring Institute:
National Institute of Allergy and Infectious Diseases (NIAID)
Recruitment Detail
Type: Active Accrual Of New Subjects
Gender: Male & Female
Referral Letter Required: No
Population Exclusion(s): None

Eligibility Criteria:
INCLUSION CRITERIA:

Normal Volunteers - ages 18-60:

Healthy without active infection or history of recurrent infections.

Normal renal function (creatinine less than or equal to 1.5 mg/dl; less than or equal to 1+ proteinuria); normal hepatic function (bilirubin less than or equal to 1.5 mg/dl); 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).

Normal female volunteers of childbearing potential may be entered if using effective contraception, and with a negative urine pregnancy test determined the day before beginning G-CSF administration.

Patients - ages 18-60:

Systemic mastocytosis patients must have mast cell hyperplasia compatible with a diagnosis of systemic mastocytosis; and be without active infection or history of recurrent infections.

Preserved renal function (creatinine less than or equal to 2mg/dl; less than or equal to 2+ proteinuria); preserved hepatic function (bilirubin less than or equal to 1.5 mg/dl); 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).

Normal female volunteers of childbearing potential may be entered if using effective contraception, and with a negative urine pregnancy test determined the day before beginning G-CSF administration.

EXCLUSION CRITERIA:

Normal Volunteers:

Active bacterial, fungal or viral infections.

HIV+ testing.

Pregnancy or lactation.

History of autoimmune disease such as rheumatoid arthritis, vasculitis, pyoderma gangrenosum or similar disorder.

Use of any investigative drugs.

Systemic Mastocytosis Patients:

Active bacterial, fungal or viral infections.

HIV+ testing.

Patients taking any other growth factors, cytokines or investigative drugs.

Patients hemodynamically unstable (blood pressure systolic of lower than 105 or diastolic lower than 65).

Pregnancy or lactation.

History of autoimmune disease such as rheumatoid arthritis, vasculitis, pyoderma gangrenosum or similar disorder.

History of splenic rupture.

Special Instructions: Currently Not Provided
Keywords:
Leukapheresis
Mastocytosis
G-CSF
Mast Cells
Progenitors
Recruitment Keywords:
Normal Volunteer
Systemic Mastocytosis
Conditions:
Mastocytosis
Investigational Drug(s):
None
Investigational Device(s):
None

Contacts:
Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations:
Identification of a point mutation in the catalytic domain of the protooncogene c-kit in peripheral blood mononuclear cells of patients who have mastocytosis with an associated hematologic disorder

Demonstration of the origin of human mast cells from CD34+ bone marrow progenitor cells

Mast cells cultured from the peripheral blood of normal donors and patients with mastocytosis originate from a CD34+/Fc RI-cell population

Active Accrual, Protocols Recruiting New Patients

If you have:


Command Menu Bar

Search The Studies | Help | Questions |
Clinical Center Home | NIH Home


Clinical Center LogoWarren Grant Magnuson Clinical Center (CC)
National Institutes of Health (NIH)
Bethesda, Maryland 20892. Last update: 10/21/2004

Search The Studies Help Questions