Status:
COMPLETED
Normal Blood, Bone Marrow and Buccal Mucosa Protocol
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Non-atopic
Atopic
Eligibility:
All Genders
18-65 years
Brief Summary
This protocol is designed to provide blood, buccal mucosa and bone marrow aspirate samples from approximately 250, healthy volunteer donors for use in in vitro studies of mast cells, mastocytosis, and...
Detailed Description
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 studies such as...
Eligibility Criteria
Inclusion
- PARTICIPANT 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.
- PARTICIPANT 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.
- BONE MARROW PROCEDURE EXCLUSION CRITERIA
- hemoglobin less than the NIH Clinical Center Clinical Research Information System (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.
Exclusion
Key Trial Info
Start Date :
March 26 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 3 2022
Estimated Enrollment :
119 Patients enrolled
Trial Details
Trial ID
NCT00806364
Start Date
March 26 2009
End Date
November 3 2022
Last Update
January 4 2023
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892