Collection and Analysis of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers

Procurement and Analysis of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers to Support Clinical and Translational Research Projects in the NHLBI

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

The purpose of this protocol is to collect and analyze blood (ages 8 and older), bone marrow (ages 18 and older), skin tissue samples (ages 18 and older), and/or buccal mucosa samples (ages 8 and older) from healthy volunteers. Samples will be used for clinical and translational research in the NHLBI 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.

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

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

Study Contact

  • Name: OPR Office of Patient Recruitment
  • Phone Number: (800) 411-1222
  • Email: ccopr@nih.gov

Study Locations

    • Maryland
      • Bethesda, Maryland, United States, 20892
        • Recruiting
        • National Institutes of Health Clinical Center
        • Contact:
          • NIH Clinical Center Office of Patient Recruitment (OPR)
          • Phone Number: TTY dial 711 800-411-1222
          • Email: ccopr@nih.gov

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

8 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Healthy Volunteers

Description

  • INCLUSION CRITERIA:

Self-declared healthy volunteer (for blood and buccal mucosa sample donors).

Be healthy, as determined by Principal Investigator or designee based on recent (<3 months) history, physical and laboratory results (for bone marrow and skin tissue sample donors).

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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 or skin tissue sampling.

EXCLUSION CRITERIA:

Unable to comprehend the investigational nature of the protocol participation.

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

Pregnancy

Age less than 18 years for skin tissue sampling, bone marrow aspirate and biopsy.

Off campus volunteers for skin tissue sampling bone marrow aspirate and biopsy.

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: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
1
Healthy Volunteers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To obtain blood, bone marrow, and skin punch biopsy samples and/or buccal mucosa samples from subjects seeking to participate as healthy volunteers in NIH laboratory research studies.
Time Frame: Ongoing
Ongoing

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Neal S Young, M.D., National Heart, Lung, and Blood Institute (NHLBI)

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.

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 3, 2007

Study Registration Dates

First Submitted

February 28, 2007

First Submitted That Met QC Criteria

February 28, 2007

First Posted (Estimated)

March 1, 2007

Study Record Updates

Last Update Posted (Estimated)

January 29, 2024

Last Update Submitted That Met QC Criteria

January 26, 2024

Last Verified

January 25, 2024

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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