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

NCT00442195 | Recruiting

• 2 other identifiers: 07011307-H-0113
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteers

Keywords

Tissue Procurement; Sample Collection; Biologic Samples; Laboratory Research Specimens; Natural History

Outcome Measures

Primary Outcomes (1)

• 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.

  Ongoing

Study Arms (1)

1

Healthy Volunteers

Eligibility Criteria

• Age: 8 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy Volunteers

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Publications (1)

• Traba J, Kwarteng-Siaw M, Okoli TC, Li J, Huffstutler RD, Bray A, Waclawiw MA, Han K, Pelletier M, Sauve AA, Siegel RM, Sack MN. Fasting and refeeding differentially regulate NLRP3 inflammasome activation in human subjects. J Clin Invest. 2015 Nov 3;125(12):4592-600. doi: 10.1172/JCI83260.

  PMID: 26529255 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

Study Officials

• Neal S Young, M.D.

  National Heart, Lung, and Blood Institute (NHLBI)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

OPR Office of Patient Recruitment

CONTACT

(800) 411-1222; ccopr@nih.gov

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2007
• First Posted: March 1, 2007
• Study Start: March 3, 2007
• Last Updated: May 22, 2026

Record last verified: 2025-12-04

Locations

US (1)