Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use

Background:

-NIH and FDA intramural investigators performing in vitro studies involving human blood
components have a need for a steady, reliable, consistent source of these blood components,
preferably derived from screened donors documented to be free of potential
transfusiontransmissible diseases.

Objectives:

- To provide a mechanism, that is reviewed and approved by IRB, for the Department of
Transfusion Medicine, Clinical Center to collect and process blood and blood components
from paid, healthy volunteer donors for distribution to NIH intramural investigators and
FDA laboratories for in vitro research use.

- 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 (research blood donors) from research risks is performed in accordance with
IRB, OPRR and other applicable Federal regulatory standards.

Eligibility:

Donors must meet the eligibility criteria for volunteer whole blood donation with the
exception of foreign travel history and other requirements, some of which are outlined below:

- Age greater than or equal to 18 years

- Weight greater than 110 pounds

- No known heart, lung, kidney disease, or bleeding disorders

- No history of sickle cell disease

- Female subjects should not be pregnant

Design:

- Donors meeting research donor eligibility criteria will be recruited to donate blood and
blood components by standard phlebotomy and apheresis techniques.

- The investigational nature of the studies in which their blood will be used, and the
risks and discomforts of the donation process will be carefully explained to the 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.

- NIH and FDA investigators requesting blood components for research use will be required
to submit an electronic (Web-based) memo of request, briefly describing the nature of
the research, and providing assurance that samples provided through this protocol will
be used solely for in vitro and not for in vivo research.

- Blood components for research use will be distributed with a unique product number, and
the DTM principal and associate investigators will serve as the custodians of the code
that links the product with a donor s identity.

- INCLUSION CRITERIA:

Donors must meet the eligibility criteria for volunteer whole blood donation defined in the
Standards of the AABB2 and the Code of Federal Regulations 21 CFR 640,3 as modified in the
2007 FDA/CBER guidance document on eligibility criteria for donors of human cells and
cellular-based products,5 with the exception of foreign travel history and other disorders
conditions as noted below.

Ability of subject to understand and the willingness to sign the written informed consent
document

Age greater than or equal to 18 years.

Weight greater than 110 pounds.

EXCLUSION CRITERIA:

No known heart, lung, kidney disease, or bleeding disorders.

No history of sickle cell disease.

No history of intravenous injection drug use in the past 5 years.

No receipt of money or drugs in exchange for sex in the past 5 years.

No history of engaging in high-risk activities for exposure to the AIDS virus, as defined
in the AABB Donor Education Materials distributed to all donors.

No history of MSM in the past 5 years

Granulocyte donors may not receive dexamethasone if they have poorly controlled
hypertension or diabetes, or if they have a history of cataracts. Hetastarch (also known as
hydroxyethyl starch or HES ) and dexamethasone may elevate blood pressure and raise blood
glucose levels, and repetitive steroid administration may increase the risk of posterior
subcapsular cataract formation or progression. Granulocyte donors may not receive
filgrastim if they have a history or symptoms of coronary heart disease. Granulocyte donors
must have an estimated glomerular filtration (eGFR) rate of > 45ml/min/1.73m2.

Female subjects should not be pregnant.

Note: Donors who have traveled to Europe, Africa, Asia, and areas of South America that
render them ineligible for allogeneic donation due to malarial risk, Zika risk and vCJD
risk, are eligible for research donations.

Donors with a history of malaria, donors who have a family history of CJD, donors who have
undergone tattooing or body piercing within the prior 12 months, donors who have received a
graft such as bone, skin or dura mater, donors who are taking finasteride or retinoids, and
donors who have had sexual contact within the past 12 months with a person who has
symptomatic hepatitis C infection or donors who have lived with a person who has hepatitis
in the last 12 months, are similarly eligible for research-use only donation on this
protocol.

Donors with a positive antibody to hepatitis B core antigen are eligible for research
donations.

Donors with HLA antibodies are eligible for research donations.

Donors who have received an experimental drug, agent, or vaccine, and who are referred for
a research plasma or leukocyte collection specifically because they were given this drug,
agent, or vaccine, are acceptable if their research product is collected for use only by
the PI who administered the experimental drug, agent or vaccine. Otherwise, they are
deferred for one year after receiving an experimental drug, agent, or vaccine.

Donors who have received a xenotranplant are eligible for research donations.

Investigators are informed that eligibility standards for research donors differ from those
for transfusion donors through an electronic User Agreement which they electronically sign
when they register to receive blood components on this protocol.