Normal Blood, Bone Marrow and Buccal Mucosa Protocol

January 3, 2023 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

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.

Study Overview

Status

Completed

Conditions

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 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.

Study Type

Observational

Enrollment (Actual)

119

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Maryland
  - Bethesda, Maryland, United States, 20892
    - National Institutes of Health Clinical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Primary Clinical

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Case-Only
Time Perspectives: Cross-Sectional

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
1 Blood, skin, stool/rectal swabs, buccal mucosa and bone marrow aspirate samples from approximately 250 healthy volunteer donors

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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. Time Frame: 12/31/2030	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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

NIH Clinical Center Detailed Web Page

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 26, 2009

Primary Completion (Actual)

January 2, 2021

Study Completion (Actual)

November 3, 2022

Study Registration Dates

First Submitted

December 9, 2008

First Submitted That Met QC Criteria