Eligibility Details:
- 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, skin and cerebrospinal fluid 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, cerebrospinal fluid and/or skin donation):
- ability to sign informed consent
- healthy, male or female
- 18-85 years of age
- willingness to provide concurrent blood sample
EXCLUSION CRITERIA (bone marrow, cerebrospinal fluid and/or skin 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 the immune response within the past month, including
oral, intravenous, or injectable steroids
- 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, skin biopsy or lumbar
puncture.
Additonal exclusion criteria (cerebrospinal fluid):
-Previous diagnosis of central nervous system pathology (including tumors,
inflammatory conditions, infection, seizure disorder, spina bifida)
- History of spinal surgery with hardware placement
- History of any spinal surgery or injections of the lumbosacral spine
- Headache on the day of donation
Additonal exclusion criteria (skin biopsy):
-History of keloid or abnormal scar formation