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Collection of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers
This study is currently recruiting participants.
Verified by National Institutes of Health Clinical Center (CC), January 2009
Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00442195
  Purpose

The Hematology Branch of the National Heart, Lung, and Blood Institute is doing a variety of laboratory research experiments that require blood and tissue samples from healthy volunteers. This protocol provides a mechanism for collecting these tissue samples. Research includes studies of normal and abnormal formation of blood cells, viral blood diseases, the role of the immune system in marrow failure and genetic risk factors for aplastic anemia.

Healthy normal volunteers 8 years of age and older may be eligible for this study. Samples are collected as follows:

  • Blood samples: Participants 8 years of age and older donate up to 4 tablespoons of blood, which is obtained from a needle placed in an arm vein.
  • Participants 8 years of age and older donate a buccal mucosa sample (cells from the inside of the cheek). The inside of the cheek is scraped gently with a nylon brush.
  • Participants 18 years of age and older donate a bone marrow sample. The bone marrow is obtained from the hip bone. The skin over the area is wiped clean with alcohol and iodine, and then a local anesthetic is injected under the skin and also into the bone. When the area is numb, a bone marrow aspiration needle is introduced through the bone surface into the marrow. The marrow cells are collected using a syringe connected to the needle.

Condition
Healthy

U.S. FDA Resources
Study Type: Observational
Study Design: Prospective
Official Title: Collection of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers

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

Study Start Date: February 2007
Detailed Description:

The purpose of this protocol is to collect blood, bone marrow, and/or buccal mucosa samples from healthy volunteers. Samples will be used for clinical and translational research in the Hematology Branch and are indispensable for many of our research projects, including studies of normal and abnormal hematopoiesis, the viral etiology of blood diseases, the role of the immune system in marrow failure and genetic risk factors for aplastic anemia. This protocol provides a mechanism for collection, tracking, storing, dispensing, analyzing and disposing of these laboratory research samples.

  Eligibility

Ages Eligible for Study:   8 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:

Self declared healthy volunteer.

Age 8 years and older (no upper limit) for blood and buccal mucosa sampling.

Or

Ages 18 years or older (no upper limit) for bone marrow sampling.

EXCLUSION CRITERIA:

Unable to comprehend the investigational nature of the protocol participation.

CBC determined outside expected normal ranges for the subject (bone marrow donors only).

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00442195

Contacts
Contact: Patient Recruitment and Public Liaison Office (800) 411-1222 prpl@mail.cc.nih.gov
Contact: TTY 1-866-411-1010

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

NIH Clinical Center Detailed Web Page  This link exits the ClinicalTrials.gov site

Study ID Numbers: 070113, 07-H-0113
Study First Received: February 28, 2007
Last Updated: January 13, 2009
ClinicalTrials.gov Identifier: NCT00442195  
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Tissue Procurement
Sample Collection
Biologic Samples
Laboratory Research
Healthy Volunteer
HV

Study placed in the following topic categories:
Healthy

ClinicalTrials.gov processed this record on January 16, 2009