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Normal Blood, Bone Marrow and Buccal Mucosa Protocol

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier:
NCT00806364
First received: December 9, 2008
Last updated: November 11, 2014
Last verified: March 2014
  Purpose

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.


Condition
Healthy

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Normal Blood, Bone Marrow and Buccal Mucosa Protocol

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 500
Study Start Date: December 2008
Detailed Description:

This protocol is designed to provide blood, skin, 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. 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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

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.

(Procedure) EXCLUSION CRITERIA

Hemoglobin less than the NIH Clinical Center CRIS normal range.

Platelets less thank 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.

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00806364

Contacts
Contact: Hyejeong Root (301) 594-1233 roothy@niaid.nih.gov
Contact: Hirsh D Komarow, M.D. (301) 594-2197 komarowh@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Hirsh D Komarow, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
  More Information

Additional Information:
Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier: NCT00806364     History of Changes
Other Study ID Numbers: 090049, 09-I-0049
Study First Received: December 9, 2008
Last Updated: November 11, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Healthy Volunteers
Allergy
Bone Marrow
Buccal Mucosa
HV
Healthy Volunteer

ClinicalTrials.gov processed this record on November 25, 2014