Increased numbers of white blood cells called eosinophils can cause disease. To investigate this disease, researchers need normal blood and bone marrow samples to compare to samples from patients with this problem. This study will collect blood and bone marrow samples from normal volunteers who meet standard blood donor criteria. Some of the samples will be used for genetic testing or future research.

This study will last for about 3 years and will include a maximum of 50 paid volunteers ages 18 to 65.

After a medical screening, volunteers will donate a blood sample and a bone marrow sample, taken from the hip bone, followed by a biopsy that will obtain a small sample of bone and bone marrow. The procedure lasts less than 1 hour. Volunteers may donate repeatedly within the limits set by the study.

Condition
Healthy

This protocol is designed to provide blood and bone marrow aspirate samples from paid, volunteer donors for use in in vitro studies of eosinophilia. Donors meeting standard blood donor eligibility criteria will be recruited to donate blood and bone marrow using conventional techniques. The investigational nature of the studies in which their blood and bone marrow will be used, as well as the risks and benefits of the donation process will be explained to all donors, and a signed informed consent document will be obtained. Donors will be compensated according to an established schedule based on the duration and discomfort of the donation. Samples provided through this protocol will be used solely for in vitro research. Blood and bone marrow samples will be assigned a unique product number, and the study investigators listed on this protocol will serve as the custodians of the code that links the product with a donor's identity. The nature of the in vitro studies in which the blood collected in this study will be used is not the subject of this protocol and will be described in general terms only, since it involves several IRB informed consent, counseling and protection of the study subjects according to IRB, OHSR, OPRR and other applicable Federal regulatory standards.

Genders Eligible for Study:  Both

Criteria

INCLUSION CRITERIA:
Ability to sign informed consent.
Healthy, male or female, and 18-65 years of age.
EXCLUSION CRITERIA:
A known clotting disorder, low platelets (less than 100k) or taking medications that interfere with blood clotting, such as aspirin, non-steroidal anti-inflammatory agents or coumadin
PT greater than 15.5 sec or PTT greater than 34.5 sec (unless known to be due lupus anticoagulant).
Anemia (hemoglobin less than 12.3 mg/dL).
Evidence of an immune deficiency, such as HIV infection or cancer.
Pregnancy.
Taking a medication that affects eosinophils, including steroids, beta-blockers and agents that affect the immune response.
Allergic to xylocaine.
Have taken an investigational drug in the last 6 months.
Any other medical condition that the investigator feels puts the participant at too high a risk for participation.
Coumadin and/or heparin treatment will not be stopped so that a subject can participate in this protocol. If coumadin or heparin was recently discontinued, a subject can be enrolled, but no bone marrow procedures will be performed until the PT is less than 15.5 seconds and the PTT is within normal range. For other agents that interfere with blood clotting without prolonging the PT, a 7 day washout period will be required before bone marrow sampling.

Maryland
      National Institute of Allergy and Infectious Diseases (NIAID), 9000 Rockville Pike,  Bethesda,  Maryland,  20892,  United States; Recruiting

Study ID Numbers:  040266; 04-I-0266
Record last reviewed:  August 12, 2004
Last Updated:  August 12, 2004
Record first received:  September 1, 2004
ClinicalTrials.gov Identifier:  NCT00090662
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-11-08