Eligibility Details:
- INCLUSION CRITERIA:
1. Normal healthy males and females, age 18 years and older.
2. Agree to DNA/RNA extraction of collected samples, and analysis and storage.
3. Health History Questionnaire, based on the American Association of Blood Banks
(AABB) guidelines (Attachment 3), is not remarkable for active infection or HIV
risk.
4. Able to speak and read English.
5. Willingness and ability to come to the NIA Clinical Research Unit at MedStar
Harbor Hospital in Baltimore every 2 years for a bone marrow aspiration
procedure.
EXCLUSION CRITERIA:
1. Unable to verify identification of volunteer by state issued ID card, driver s
license, or military ID. Participants earning greater than $600.00/year are issued a
1099 form, therefore, positive identification is required.
2. Unable to provide informed consent
3. Allergy to Lidocaine (numbing agent) used during bone marrow aspiration procedure
4. Test results are positive for viral infections such as RPR, HIV, Hepatitis B surface
antigen or hepatitis C antibodies. For participants who have been treated for
Hepatitis C, screening blood work must show HCV RNA quantitative is not detectable.
Researchers are seeking healthy, pristine cells. Due to the ongoing nature of these
chronic viral and bacterial infections, the blood cell populations will change.
Researchers want to study changing cell populations as a factor of aging only and not
those altered by infections.
5. Ongoing risk factors for HIV or Hepatitis B or C such as: intravenous drug use,
non-monogamous unprotected intercourse. These viruses weaken the immune system and
cause changes in the white blood cells and their progenitors.
6. Major medical illnesses such as any type of liquid or solid tumor cancer, history of
deep vein thrombosis, auto-immune disorders, organ or bone marrow transplant, or
liver, kidney, heart or lung disease.
7. A medical finding that shows a participant could not safely go through this procedure.
(such as Parkinson s disease, dementia or any uncontrolled behavior that would place
the participant s safety at risk)
8. Bleeding conditions such as hemophilia or von Willebrand s disease.
9. Significant abnormalities are found in the results of blood tests such as elevated
liver enzymes (2x normal for MedStar Harbor Hospital Clinical Laboratory parameters),
abnormal kidney function, positive viral titers, GFR <30.
10. On any medication that can alter blood cell function such as chronic steroid use,
histamine-2 blockers, antivirals or past or present chemotherapy (complete list
located in the Cytapheresis Screening manual stored in the NIA Cytapheresis Unit).
11. Radiation therapy past or present.
12. Inability of researchers to access iliac crest from conditions such as wounds, rashes,
or large deposits of adipose tissue that makes localization of the iliac crest
difficult.
13. Organ transplant or any graft such as tissue, bone or skin as we don t know how this
impacts progenitor cells.
In addition, eligible participants may not be able to participate in a specific bone marrow
aspiration procedure but might be eligible at a later date. These include:
1. Pregnancy and Nursing Mothers: Females who are pregnant or who have had a pregnancy in
the last 6 weeks are temporarily deferred. They may resume participation in the study
6 weeks after delivery or cessation of lactation and have been cleared by their
obstetrician or primary care physician.
2. Medication: Volunteers taking the following medications would be deferred for 2 weeks
after course has been completed and volunteer is feeling well: Antibiotics,
antifungals, antimalarials.
3. Temporary steroids (tapers): Deferred for 72 hours after symptoms are resolved and
prescription is completed if taken orally, intravenously, or intramuscular. No
deferral if taken intranasal or for joint injection.
4. Hepatitis B immune globulin: Volunteers are deferred 6 months if given after exposure
to hepatitis B to insure the volunteer has not been infected. If administered for
prophylaxis, no deferral is necessary.
5. Live Attenuated Virus Vaccinations: Defer for 4 weeks if symptomfree.
6. Inactivated (Killed Virus) Vaccinations: Defer for 2 weeks if symptom-free.
7. Rabies Vaccine: Deferred for 1 year if given for rabies exposure; otherwise accept
immediately if symptom-free.
8. Smallpox Vaccine: Deferred until the scab has separated from the skin spontaneously or
21 days from date of immunization, whichever is longer, if volunteer had no other
symptoms or complications. Visual verification of absence of vaccine scab is required.
If scab was otherwise removed (not spontaneously separated), defer for 2 months after
vaccination date.
9. Experimental Medication or Unlicensed (Experimental) Vaccine is usually associated
with a research protocol and the effect on bone marrow is unknown. Deferral is one
year unless otherwise indicated by the Principal Investigator.
10. Infection or Fever: Deferred until 2 weeks after antibiotics are completed and
volunteer is feeling well.
11. Surgical Procedures: Deferred for 3 months after procedure and released to return to
normal activities by primary care physician or surgeon.
12. Close contact with someone else s blood, accidental needle-stick, treatment for
syphilis or gonorrhea-Volunteers are deferred for 6 months to insure they have not
been infected. Viral/serology testing will be repeated and verified as negative prior
to bone marrow aspiration procedure.
1. Received money, drugs or other payment for sex or having sexual contact with a
prostitute or anyone else who takes money or drugs or other payment for sex
2. Has used needles to take drugs, steroids or anything NOT prescribed by their
doctor or had sexual contact with anyone who has ever used needles to take drugs
or steroids, or anything NOT prescribed by their doctor.
3. Had sexual contact with or living with anyone who has hepatitis.
4. Had a tattoo using non-sterile needles or reused ink.
5. Had a body piercing that used non-sterile needles or multi-use equipment.
13. Had close contact with someone who had a smallpox vaccination such as touching the
vaccination site, handling bedding or clothing that has been in contact with an
unbandaged vaccination site to insure they have not been infected: Deferral is 2
months if volunteer is symptom-free.
14. Anemia/Leukopenia/Thrombocytopenia:
1. Volunteers with a hemoglobin of <12.0 for men, <11.0 for women or hematocrit <38
for men, <36 for women may return in 8 weeks to repeat labs to verify anemia.
Eligible for procedure once values have returned to normal.
2. White blood cell count <3.0.
3. Platelet count <150,000.
4. Whole blood donation (450 mL) or bone marrow aspiration procedure: Deferred 56
days from date of last donation as mandated by AABB guidelines. e. Double unit
red cell donation: Deferred for 112 days (16 weeks) as mandated by AABB
guidelines.
f. Platelet or plasma donation: Deferred for 28 days from date of last donation as
mandated by AABB guidelines.
g.There will be no deferral for leukocyte apheresis donation as
we believe it is safe to perform leukocyte donationapheresis and
bone marrow aspiration on the same day on normal healthy volunteers. For research
purposes, we will perform bone
marrow aspiration first if both procedures are done on the same
day.
15. Received blood transfusion: Deferral is for 12 months to ensure volunteer has not
acquired an infectious disease. Annual laboratory testing will be repeated prior to
bone marrow aspiration procedure.
16. It is less than six weeks since participation in another research study which is felt
by the Principal Investigator to be incompatible with this study. (for example:
studies that collect blood, investigational drug studies, vaccine trials, etc.)
17. Travel:
Malaria-endemic countries: Volunteers who are residents of such countries will be deferred
for 3 years after departure from the country if they remain free from unexplained symptoms
suggestive for malaria. Residence is defined as a continuous stay of longer than 5 years in
a country or countries having any malaria-endemic area.
Volunteers who are not prior residents of malaria-endemic countries and travel to a
malaria-endemic area will be deferred for 12 months after departure from that area. The
duration of travel to a malaria-endemic area is defined as more than 24 hours to less than
5 years. Note that a passage greater than 24 hours through a malaria-endemic area while on
route to a malaria-free area is considered a sufficient possible exposure to trigger
deferral.
(A complete list of malarial-endemic countries is kept in the Cytapheresis Screening Manual
and is stored in the NIA Apheresis Unit.)