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Protocol Details

Collection of Data and Samples from Healthy Donors for Use in Translational Research

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Institute of Allergy and Infectious Diseases (NIAID)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: 65 Years

Referral Letter Required


Population Exclusion(s)



Cerebrospinal Fluid;
Natural History;

Recruitment Keyword(s)

Healthy Volunteer;


Healthy Volunteer

Investigational Drug(s)


Investigational Device(s)




Supporting Site

National Institute of Allergy and Infectious Diseases

Increased numbers of white blood cells called eosinophils can cause disease. To investigate this disease, researchers need blood, urine, sputum, stool, cerebrospinal fluid, skin and/or bone marrow samples to compare to samples from patients with this problem. Some of the samples will be used for genetic testing or future research.

This study will last for about 10 years and will include a maximum of 50 paid volunteers ages 18 to 65.

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Eligibility criteria for volunteer whole blood donation are based on the Standards of the AABB(2) and the Code of Federal Regualtions 21 CFR 640(3). Specific criteria follow:

INCLUSION CRITERIA (blood, urine, stool and/or sputum donation):

-ability to sign informed consent

-healthy, male or female

-18-85 years of age

EXCLUSION CRITERIA (blood, urine, stool and/or sputum donation):


-weight <110 pounds

-history of heart, lung, kidney disease, chronic anemia or bleeding disorders

Eligibility criteria for volunteer bone marrow, skin and cerebrospinal fluid donation are more stringent than those for other specimen donations to minimize risk of procedure complications and maximize utility of specimens for study:

INCLUSION CRITERIA (bone marrow, cerebrospinal fluid and/or skin donation):

-ability to sign informed consent

-healthy, male or female

-18-85 years of age

-willingness to provide concurrent blood sample

EXCLUSION CRITERIA (bone marrow, cerebrospinal fluid and/or skin donation):

-a known bleeding disorder, low platelets (<100k) or taking medications that interfere with blood clotting, such as aspirin, non-steroidal antiinflammatory agents or warfarin

-anemia (hemoglobin less than 12.3 mg/dL)

-evidence of an immune deficiency, such as HIV infection or cancer


-taking a medication that affects the immune response within the past month, including oral, intravenous, or injectable steroids

-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

*warfarin and/or heparin treatment will not be stopped so that a subject can participate in this protocol. If warfarin or heparin was recently discontinued, a subject can be enrolled, but no bone marrow procedures will be performed until the PT is < 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, skin biopsy or lumbar puncture.

Additonal exclusion criteria (cerebrospinal fluid):

-Previous diagnosis of central nervous system pathology (including tumors,

inflammatory conditions, infection, seizure disorder, spina bifida)

-History of spinal surgery with hardware placement

-History of any spinal surgery or injections of the lumbosacral spine

-Headache on the day of donation

Additonal exclusion criteria (skin biopsy):

-History of keloid or abnormal scar formation

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Not Provided

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Principal Investigator

Referral Contact

For more information:

Amy D. Klion, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
NIHBC 04 BG RM B1-28
(301) 435-8903

Thomas W. Brown, R.N.
National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health
Building 10
10 Center Drive
Bethesda, Maryland 20892
(301) 402-7823

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1

Clinical Trials Number:


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