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

Collection of Blood, Bone Marrow, Skin Biopsies 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, normal tissue and bone marrow samples and/or leukopheresis cells 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).
• Normal tissue samples will be obtained from volunteers 18 years of age and older by taking superficial skin samples (punch biopsies)
• Leukopheresis or lymphapheresis will be performed on volunteers 18 years of age and older to obtain white blood cells for research
• 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 Overview

• Status: Completed
• Conditions: Healthy Volunteers

Detailed Description

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), normal tissue (ages18 and older) bone marrow (ages 18 and older) and/or leukapheresis cells (ages 18 and older) from healthy volunteers, including pregnant women (ages 18 and older, blood and/or buccal mucosa only). To be enrolled on this study, pregnant women must not carry the diagnosis of an immune-mediated or inflammatory disease, or have signs or symptoms of an immune or inflammatory disease; otherwise they may be eligible for participation on CHI protocol 10-H-0162 in the affected adult cohort. 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.

• Study Type: Observational
• Enrollment (Actual): 88

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • National Institutes of Health Clinical Center, 9000 Rockville Pike

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

• 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 or normal tissue 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)
• Must be willing to allow samples to undergo genetic studies.

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mechanism for collecting samples	One time point

Collaborators and Investigators

• Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Angelique Biancotto, Ph.D., National Institute of Allergy and Infectious Diseases (NIAID)

Study record dates

Study Major Dates

• Study Start: September 9, 2009
• Primary Completion: December 7, 2022
• Study Completion: September 5, 2018

Study Registration Dates

• First Submitted: October 14, 2009
• First Submitted That Met QC Criteria: October 14, 2009
• First Posted (Estimate): October 15, 2009

Study Record Updates

• Last Update Posted (Actual): December 5, 2019
• Last Update Submitted That Met QC Criteria: December 4, 2019
• Last Verified: September 5, 2018

More Information

Terms related to this study

• Keywords: HV; Healthy Volunteer; Biologic Samples; Laboratory Research Specimens; Sample Collection; Tissue Procurement
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases
• Other Study ID Numbers: 090229; 09-H-0229

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No