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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00442195
• Other study ID #: 070113
• Secondary ID: 07-H-0113
• Status: Recruiting
• Start date: March 3, 2007

Study information

• Verified date: May 15, 2024
• Source: National Institutes of Health Clinical Center (CC)
• Contact: OPR Office of Patient Recruitment
• Phone: (800) 411-1222
• Email: ccopr[@]nih.gov
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 99 Years

Eligibility

• 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.

Related Conditions & MeSH terms

• Healthy Volunteers

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   NIH Clinical Center Detailed Web Page