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Normal Blood, Bone Marrow and Buccal Mucosa Protocol

NCT00806364 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 119

Last updated 2023-01-04

No results posted yet for this study

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.

Conditions

  • Non-atopic
  • Atopic
  • Healthy
  • Normal
  • Allergy

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Hirsh D Komarow, M.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-03-26
Primary Completion
2021-01-02
Completion
2022-11-03

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00806364 on ClinicalTrials.gov