Bethesda, Maryland 20892


Purpose:

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.


Study summary:

This protocol is designed to provide blood, urine, sputum, stool and bone marrow aspirate samples from paid, volunteer donors for use in in vitro studies of eosinophilia and parasitic diseases. Donors meeting standard normal donor eligibility criteria will be recruited to donate blood, urine, sputum, stool and/or bone marrow using conventional techniques. The investigational nature of the studies in which their samples 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, urine, sputum, stool 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 specimens 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 approved LPD protocols. Because some of these protocols require normal controls without a history of asthma or allergic disease, all subjets will undergo a standardized allergy/asthma history at enrollment. Serum immunoglobulin levels and a basic RAST panel may be performed on sera from some normal donors, and some normal donors may be asked t undergo pulmonary function testing.This protocol is designed to assure adequate and complete informed consent, counseling and protection of the study subjects according to IRB, OHSR, OPRR and other applicable Federal regulatory standards.


Criteria:

- 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, and 18-85 years of age. Eligibility criteria for volunteer bone marrow donation are more stringent than those for other specimen donations to minimize risk of procedure complications and maximize utility of specimens for study: Bone Marrow Donation - Ability to sign informed consent. - Healthy, male or female, and 18 65 years of age EXCLUSION CRITERIA (BLOOD, URINE, STOOL AND/OR SPUTUM DONATION): - Pregnancy - Weight less than 110 pounds - History of heart, lung kidney disease, chronic anemia or bleeding disorders Bone Marrow Donation - A known bleeding disorder, low platelets (less than 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 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. 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 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.


NCT ID:

NCT00090662


Primary Contact:

Principal Investigator
Amy D Klion, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)

Thomas W Brown, R.N.
Phone: (301) 402-7823
Email: thomas.brown2@nih.gov


Backup Contact:

Email: aklion@niaid.nih.gov
Amy D Klion, M.D.
Phone: (301) 435-8903


Location Contact:

Bethesda, Maryland 20892
United States

For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)
Phone: 800-411-1222
Email: prpl@mail.cc.nih.gov

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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