Normal Blood, Bone Marrow and Buccal Mucosa Protocol

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.

- 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.