Status:
RECRUITING
Collection of Data and Samples From Healthy Donors for Use in Translational Research
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Healthy Volunteer
Eligibility:
All Genders
18-85 years
Brief 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 sam...
Detailed Description
This protocol is designed to provide data and samples from paid volunteers for use in translational studies of eosinophilia and parasitic diseases. Donors meeting standard normal donor eligibility cri...
Eligibility Criteria
Inclusion
- 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:
- INCLUSION CRITERIA (blood, urine, stool, infrared thermograpy, photography, gastrointestinal secretion, pulmonary function testing
- and/or sputum donation)
- ability to sign informed consent
- healthy male or female
- 18-85 years of age
- EXCLUSION CRITERIA (blood, urine, stool, infrared thermograpy, photography, gastrointestinal secretion, pulmonary function testing
- 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:
- INCLUSION CRITERIA (bone marrow, cerebrospinal fluid and/or skin donation)
- ability to sign informed consent
- healthy, male or female
- 18-65 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 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.
- Additional 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
- Additional exclusion criteria (skin biopsy)
- History of keloid or abnormal scar formation
Exclusion
Key Trial Info
Start Date :
December 9 2004
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00090662
Start Date
December 9 2004
Last Update
January 8 2026
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892