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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00806364
Other study ID # 090049
Secondary ID 09-I-0049
Status Completed
Phase
First received
Last updated
Start date March 26, 2009
Est. completion date November 3, 2022

Study information

Verified date November 2022
Source National Institutes of Health Clinical Center (CC)
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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 studies of cells of the immune system, mastocytosis, and allergic diseases. Participants will donate samples using conventional techniques. The investigational nature of the studies in which 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. Samples will be assigned a unique product number, and the study investigators 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 Protections, Office for Human Research Protections (OHRP) and other applicable Federal regulatory standards.


Recruitment information / eligibility

Status Completed
Enrollment 119
Est. completion date November 3, 2022
Est. primary completion date January 2, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility - 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States National Institutes of Health Clinical Center Bethesda Maryland

Sponsors (1)

Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Hamilton RG, Adkinson NF Jr. 23. Clinical laboratory assessment of IgE-dependent hypersensitivity. J Allergy Clin Immunol. 2003 Feb;111(2 Suppl):S687-701. doi: 10.1067/mai.2003.123. — View Citation

Standards for blood banks and transfusion services. QRB Qual Rev Bull. 1977 Dec;3(12):17,22. No abstract available. — View Citation

Vidal C, Gude F, Boquete O, Fernandez-Merino MC, Meijide LM, Rey J, Lojo S, Gonzalez-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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary To provide an Institutional Review Board (IRB)-approved mechanism for the collection of peripheral blood, skin, bone marrow and/or buccal mucosa samples from healthy volunteer donors for use in in vitro studies. To provide an Institutional Review Board (IRB)-approved mechanism for the collection of peripheral blood, skin, bone marrow and/or buccal mucosa samples from healthy volunteer donors for use in in vitro studies. 12/31/2030
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