Protocol Details

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

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number	09-H-0229
Sponsoring Institute	National Heart, Lung and Blood Institute (NHLBI)
Recruitment Detail	Type: Participants currently recruited/enrolled Gender: Male & Female Min Age: 8 Max Age: N/A
Referral Letter Required	No
Population Exclusion(s)	None
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	National Heart, Lung, and Blood Institute

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.

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Eligibility

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 and/or leukapheresis cells

Or

Pregnant women (health status confirmed by brief History and Physical Exam and blood work) must be 18 years or older (no upper limit) for blood and/or buccal mucosa 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:

- Healthy volunteers and/or pregnant women with diseases with an inflammatory or immune component

- Subjects with active infections requiring systemic antibiotic therapy

- Persons who are alcoholic or abusers of illicit substances

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Citations:

Not Provided

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Contacts:

Principal Investigator	Referral Contact	For more information:
Shira Y. Perl, M.D. National Heart, Lung and Blood Institute (NHLBI) National Institutes of Health Building 10 Room 9N119 10 Center Drive Bethesda, Maryland 20892 (301) 435-7880 perls@mail.nih.gov	Paula Schum, R.N. National Heart, Lung and Blood Institute (NHLBI) National Institutes of Health Building 15F Room 100 9000 Rockville Pike Bethesda, Maryland 20892 (301) 402-3796 schump@mail.nih.gov	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 prpl@mail.cc.nih.gov

Clinical Trials Number:

NCT00995891

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