NIH Clinical Research Studies

Protocol Number: 09-I-0049

Active Accrual, Protocols Recruiting New Patients

Title:
Normal Blood, Bone Marrow and Buccal Mucosa Protocol
Number:
09-I-0049
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 allergic diseases. Non-atopic donors will be recruited to donate blood, bone marrow, and/or buccal mucosa samples using conventional techniques. The investigational nature of the studies in which their blood, bone marrow and buccal mucosa 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 donations. Samples provided through this protocol will be used solely for in vitro research. Blood, bone marrow, and buccal mucosa 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 blood collected in this study will be used is not the subject of this protocol and will be described in general terms only. The samples will be used in several Institutional Review Board (IRB)-approved Laboratory of Allergic Diseases (LAD) protocols. This protocol is designed to assure adequate and complete informed consent, counseling, and protection of the study subjects according to IRB, Office of Human Subjects Research (OHSR), Office for Human Research Protections (OHRP) and other applicable Federal regulatory standards.
Sponsoring Institute:
National Institute of Allergy and Infectious Diseases (NIAID)
Recruitment Detail
Type: Participants currently recruited/enrolled
Gender: Male & Female
Referral Letter Required: No
Population Exclusion(s): Children

Eligibility Criteria:
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.

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.

History of allergy to lidocaine.

Have taken an investigational drug in the last 6 months.

Apheresis in the past 6 weeks.

Any other medical condition that the investigator feels puts the participant at too high a risk for participation.

* 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 prothrombin time is less than 15.2 seconds and the partial thromboplastin time is within normal range. For other agents that interfere with blood clotting without prolonging the prothrombin time, a 7-day washout period will be required before bone marrow sampling.

(Procedure) EXCLUSION CRITERIA

Hemoglobin less than 12.3 mg/dl.

Platelets less thank 100, 000/mm(3).

PT greater than 15.2 seconds or PTT greater than 37.3 seconds

Positive b-HCG.

EKG changes suggestive of cardiovascular disease.

Any other lab value which may put the subject at risk during the procedure.

Special Instructions:
Currently Not Provided
Keywords:
Healthy Volunteers
Allergy
Bone Marrow
Buccal Mucosa
Recruitment Keyword(s):
HV
Healthy Volunteer
Condition(s):
Healthy
Investigational Drug(s):
None
Investigational Device(s):
None
Intervention(s):
None
Supporting Site:
National Institute of Allergy and Infectious Diseases

Contact(s):
Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):
Vidal C, Gude F, Boquete O, Fern‡ndez-Merino MC, Meijide LM, Rey J, Lojo S, Gonz‡lez-Quintela A. Evaluation of the phadiatop test in the diagnosis of allergic sensitization in a general adult population. J Investig Allergol Clin Immunol. 2005;15(2):124-30.

Hamilton RG, Adkinson NF Jr. 23. Clinical laboratory assessment of IgE-dependent hypersensitivity. J Allergy Clin Immunol. 2003 Feb;111(2 Suppl):S687-701.

Standards for blood banks and transfusion services. QRB Qual Rev Bull. 1977 Dec;3(12):17,22.

Active Accrual, Protocols Recruiting New Patients

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