Bethesda, Maryland 20892


Purpose:

This protocol is designed to provide blood, buccal mucosa and bone marrow aspirate samples from approximately 250, healthy volunteer donors for use in in vitro studies of mast cells, mastocytosis, and allergic diseases. Non-atopic donors will be recruited to donate blood, bone marrow, and/or buccal mucosa samples using conventional techniques. The investigational nature of the studies in which their blood, bone marrow and buccal mucosa 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 donations. Samples provided through this protocol will be used solely for in vitro research. Blood, bone marrow, and buccal mucosa 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 blood collected in this study will be used is not the subject of this protocol and will be described in general terms only. The samples will be used in several Institutional Review Board (IRB)-approved Laboratory of Allergic Diseases (LAD) protocols. This protocol is designed to assure adequate and complete informed consent, counseling, and protection of the study subjects according to IRB, Office of Human Subjects Research (OHSR), Office for Human Research Protections (OHRP) and other applicable Federal regulatory standards.


Study summary:

This protocol is designed to provide blood, skin, stool/rectal swabs, buccal mucosa and bone marrow aspirate samples from approximately 250 healthy volunteer donors for use in in vitro such as studies of cells of the immune system, mastocytosis, and allergic diseases. Participants will donate samples using conventional techniques. The investigational nature of the studies in which 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 donations. Samples provided through this protocol will be used solely for in vitro research. 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 blood collected in this study will be used is not the subject of this protocol and will be described in general terms only. The samples will be used in several Institutional Review Board (IRB)-approved Laboratory of Allergic Diseases (LAD) protocols. This protocol is designed to assure adequate and complete informed consent, counseling, and protection of the study subjects according to IRB, Office of Human Subjects Research (OHSR), Office for Human Research Protections (OHRP) and other applicable Federal regulatory standards.


Criteria:

- INCLUSION CRITERIA: Ability to sign informed consent. Healthy male or female between 18-65 years of age. Willing to have samples stored for future research. EXCLUSION CRITERIA: History of an immune deficiency, such as HIV infection or cancer. History of chronic hepatitis B and/or C infection. History of chronic anemia. A known clotting disorder or taking medications that interfere with blood clotting, such as: aspirin, heparin, or Coumadin* Current pregnancy. Have taken an investigational drug in the last 6 months that may affect the normal process of blood cells. Any condition that in the view of the principal investigator (PI) would make the subject unsuitable for enrollment in this study. * Coumadin and/or heparin treatment will not be stopped so that a subject can participate in this protocol. If Coumadin or heparin was recently discontinued, a subject can be enrolled, but no bone marrow procedures will be performed until the PT and the PTT are 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. (Procedure) EXCLUSION CRITERIA Hemoglobin less than the NIH Clinical Center CRIS normal range. Platelets less than 100,000/mm(3). PT or PTT greater than the NIH Clinical Center CRIS normal range Positive b-HCG. EKG changes suggestive of cardiovascular disease. Unable or unwilling to have bone marrow biopsy performed without use of conscious sedation, and use of only local anesthetic during procedure Any other lab value which may put the subject at risk during the procedure.


NCT ID:

NCT00806364


Primary Contact:

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

Robin R. Eisch, R.N.
Phone: (301) 443-1720
Email: eischar@mail.nih.gov


Backup Contact:

Email: komarowh@mail.nih.gov
Hirsh D Komarow, M.D.
Phone: (301) 594-2197


Location Contact:

Bethesda, Maryland 20892
United States

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
Phone: 800-411-1222
Email: prpl@cc.nih.gov

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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