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

National Institutes of Health (NIH)

Status: Enrolling

Conditions: Healthy Volunteers

Study type: Observational

Funder types: NIH

Identifiers

NCT00442195

070113

07-H-0113

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 8 to 99 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

• 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.

Trial design

1,000 participants in 1 patient group

1

Description:

Healthy Volunteers