Protocol Number: 09-HI-0229

Title:

Collection of Blood, Bone Marrow, and Buccal Mucosa Samples from Healthy Volunteers for Center for Human Immunology, Autoimmunity, and Inflammatory Diseases (CHI) Protocols Laboratory Research Studies

Number:

09-HI-0229

Summary:

Background:

- Laboratory research studies require control samples from healthy volunteers to compare with samples from patients. These studies will help researchers better understand and refine treatments for immune system and inflammatory diseases.

Objective:

- To obtain blood, urine, buccal (mouth) mucosa, and bone marrow samples from healthy volunteers.

Eligibility:

- Healthy individuals at least 8 years of age.

Design:

- Volunteers will be recruited through the Program for Healthy Volunteers, Patient Recruitment and Public Liaison Office, or self-referral through the clinicaltrials.gov Web site.

- Health will be confirmed by a brief history and physical examination and blood work.

- Volunteers 8 years of age and older will provide blood and urine samples using standard procedures. Buccal mucosa samples will be obtained by scraping the insides of both cheeks with a sterile nylon brush.

- Bone marrow samples will be obtained from volunteers 18 years of age and older by taking two aspirates from the posterior iliac crest (an area near the hip).

- Samples will be assigned a unique code and will be stored until they are no longer of scientific value or the volunteer withdraws consent for their use.

Sponsoring Institute:

Center for Human Immunology (CHI)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): None

Eligibility Criteria:

INCLUSION CRITERIA:

- Healthy volunteer (health status confirmed by brief History and Physical Exam and blood work)

- Age 8 years and older (no upper limit) for blood, urine, and buccal mucosa sampling

Or

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

- Able to comprehend the investigational nature of the protocol and provide informed consent (If the healthy volunteer is a minor, the minor's parent or guardian must provide consent and the minor must be able to provide assent)

EXCLUSION CRITERIA:

- Patients with diseases with an inflammatory or immune component

- Patients with active infections requiring systemic antibiotic therapy

- Persons who are alcoholic or abusers of illicit substances

Special Instructions:

Currently Not Provided

Keywords:

Tissue Procurement

Normal Volunteers

Bone Marrow Aspirate

Buccal Mucosa

Blood Sample

Recruitment Keyword(s):

HV

Healthy Volunteer

Condition(s):

Healthy

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

Center for Human Immunology

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s): Not Provided

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Clinical Research Informatics, CC.

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