Official 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”

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....

Study Type: Observational

Study Design: Prospective

The purpose of this protocol is to collect blood (ages 8 and older), urine (ages 8 and older), buccal mucosa samples (ages 8 and older) and/or bone marrow (ages 18 and older) from healthy volunteers. Samples will be used as controls for clinical and translational research in the Center for Human Immunology, Autoimmunity, and Inflammatory Diseases (CHI). These control samples are indispensable for many of our laboratory research projects, including understanding the pathophysiology of a wide variety of immune-mediated and inflammatory diseases.

The primary objective is to provide a mechanism for collection, tracking, storing, dispensing, analyzing and disposing of these laboratory research samples from healthy volunteers. There is no primary endpoint.

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 8 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

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

Overall Clinical Trial Officials and Contacts

Overall Contact: Patient Recruitment and Public Liaison Office (800) 411-1222 prpl@mail.cc.nih.gov

Information obtained from ClinicalTrials.gov on February 08, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00995891

Study ID Number: 090229

ClinicalTrials.gov Identifier: NCT00995891

Health Authority: United States: Federal Government

NIH Clinical Center Detailed Web Page