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.
Primary Outcome Measures:
- To provide an IRB-approved mechanism for the collection of peripheral blood, urine, sputum and bone marrow samples from paid, volunteer donors for use in in vitro studies. [ Time Frame: Throughout the course of the study ]
- To provide adequate and complete informed consent to the donors of research blood samples, and to assure that the education, counseling and protection of the study subjects from research risks is performed in accordance with IRB, OHRP, and other... [ Time Frame: Throughout the course of the study ]
| Estimated Enrollment:
| Study Start Date:
||August 27, 2004
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.