Collection of Peripheral Blood and Bone Marrow From Healthy Donors for Use in In Vitro Research
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.
|Official Title:||Collection of Peripheral Blood, Urine, Sputum, and Bone Marrow From Healthy Donors for Use in In Vitro Research|
|Study Start Date:||August 2004|
This protocol is designed to provide blood, urine, sputum, and bone marrow aspirate samples from paid, volunteer donors for use in in vitro studies of eosinophilia. Donors meeting standard blood, urine, and sputum donor eligibility criteria will be recruited to donate blood, urine, sputum, 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 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. 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00090662
|Contact: Tamika S Magee, R.N.||(301) firstname.lastname@example.org|
|Contact: Amy D Klion, M.D.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||Amy D Klion, M.D.||National Institute of Allergy and Infectious Diseases (NIAID)|