Anti-Pseudomonas Immune Status and Dendritic Cell Preparation in Normal Individuals

NCT00320164 | Completed

• 1 other identifier: Dendritic Cells
• Study Type: observational
• Target: 8
• Locations: 0 countries
• Sites: N/A

Brief Summary

This protocol aims to collect human peripheral blood mononuclear cells for the production of dendritic cells (DC). There are two ways to collect human peripheral blood mononuclear cells in this protocol. One is by using the method of leukapheresis from normal healthy adults. The other is by drawing the blood from normal healthy adults and then getting the buffy coats from the blood.

Conditions

Healthy

Keywords

Healthy Volunteers

Study Arms (2)

Group A: Leukapheresis

Subject's peripheral blood mononuclear cells are collected via leukapheresis.

Group B: Buffy Coats Collection

Subject's peripheral blood mononuclear cells are collected via the buffy coats from blood.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Group A is for leukapheresis and Group B is for buffy coats collection. We will use either Group A or Group B or both to collect mononuclear cells. The source of potential subjects in both groups will be normal individuals recruited from the population of healthy individuals. Accrual will be random with no bias as to gender or racial/ethnic group. Nevertheless, because the accrual process will be random, it is possible that there may be differences in the proportion of males and females, and racial/ethnic groups. The study volunteers will be recruited through IRB approved advertisements placed in local newspapers and fliers. All efforts will be made to recruit women and minorities.

You may qualify if:

• All study subjects must be capable of providing informed consent.
• Normal male or female, age 18 and older.
• Not taking corticosteroids
• Not taking any prescription or over-the-counter medication, except acetaminophen (tylenol)
• Participants of Group A must have adequate peripheral veins for leukapheresis
• Study subjects should not be taking experimental medications.
• Females cannot be pregnant.

You may not qualify if:

• Individuals with active infection in the 3 weeks prior to beginning the protocol will not be able to participate.
• Individuals with evidence of significant cardiac, pulmonary, renal, endocrine, central nervous system, major psychiatric disorder that would prevent compliance or substance abuse, musculoskeletal disease or immunodeficiency disease, (including evidence of human immunodeficiency virus infection, HIV) will be unable to participate in the protocol.
• Individuals participating in any other experimental clinical studies.
• Women who are pregnant or nursing.
• Active or recent drug users

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Officials

• Neil R. Hackett, Ph.D.

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2006
• First Posted: May 3, 2006
• Study Start: January 1, 2006
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: May 24, 2017

Record last verified: 2017-05