Collection of Peripheral Blood and Bone Marrow From Healthy Donors for Use in In Vitro Research

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.

- 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

- 18-85 years of age

EXCLUSION CRITERIA (blood, urine, stool and/or sputum donation):

- pregnancy

- weight <110 pounds

- history of heart, lung, kidney disease, chronic anemia or bleeding disorders

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:

INCLUSION CRITERIA (bone marrow donation):

- ability to sign informed consent

- healthy, male or female

- 18-85 years of age

EXCLUSION CRITERIA (bone marrow donation):

- a known bleeding disorder, low platelets (<100k) or taking medications that interfere
with blood clotting, such as aspirin, non-steroidal antiinflammatory 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, betablockers 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 < 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.