RecruitingNCT00090662

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

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Enrollment

150 participants

Start Date

Dec 9, 2004

Study Type

OBSERVATIONAL

Conditions

Healthy Volunteer

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria9

Eligibility criteria for volunteer whole blood donation are based on the Standards of the AABB(2) and the Code of Federal Regulation 21 CFR 640(3). Specific criteria follow:
and/or sputum donation)
ability to sign informed consent
healthy male or female
-85 years of age
ability to sign informed consent
healthy, male or female
-65 years of age
willingness to provide concurrent blood sample

Exclusion Criteria21

and/or sputum donation)
pregnancy
weight <110 pounds
history of heart, lung, kidney disease, chronic anemia or bleeding disorders
Eligibility for tissue biopsy donation (other than skin) will be determined by the protocol under which the procedure is performed and the physician performing the procedure.
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:
a known bleeding disorder, low platelets (<100k) or taking medications that interfere with blood clotting, such as aspirin, non-steroidal anti-inflammatory agents or warfarin
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 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.
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
History of keloid or abnormal scar formation

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Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

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NCT00090662

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