Cytapheresis of Volunteer Donors

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute on Aging (NIA) )
ClinicalTrials.gov Identifier:
NCT00104325
First received: February 24, 2005
Last updated: October 4, 2014
Last verified: November 2013
  Purpose

Background:

- National Institute on Aging researchers are looking at studies that require large numbers of white blood cells for lab use. Standard blood samples do not provide enough white blood cells for these studies. Researchers want to use cytapheresis to collect white blood cells from volunteer donors. This procedure can collect larger amounts of white blood cells and reduce the amount of fluid and other cells that are lost.

Objectives:

- To use cytapheresis to collect white blood cells for study.

Eligibility:

- Healthy blood donors at least 18 years of age.

Design:

  • Participants will be screened according to the usual blood donation procedures.
  • Participants will provide white blood cells through cytapheresis. The blood cells will be collected in a machine that separates the white blood cells from the rest of the blood. The rest of the blood will be returned to the donor.
  • Participants may have this type of donation every 56 days (six times per year). They will be asked to become a repeat donor. A donation schedule may be set up.
  • Once a year, participants will have blood tests to continue to be eligible as a donor.

Condition
Cytapheresis

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Cytapheresis of Volunteer Donors

Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Mechanism to collect and process components from healthy donors for distribution for in vitro research [ Time Frame: Ongoing ] [ Designated as safety issue: No ]

Estimated Enrollment: 10000
Study Start Date: January 2003
Detailed Description:

Cytapheresis is an automated method/process of cell removal and collection that involves a continuous flow cell separation by centrifugation and the withdrawal of a particular blood component. This allows blood components not collected to be continuously returned to the donor. Guidance and recommendations for the performance of these procedures are provided in detail in the Standards of the American Association of Blood Banks (AABB) and in the Code of Federal Regulations (CFR).

This study is designed to provide white blood cells obtained by Cytapheresis to National Institute on Aging (NIA) researchers for other in-vitro research studies.

The study population consists of healthy males and females 18 years and older. Study subjects are anticipated to be non-patient community volunteers. Individuals will not be excluded based on gender, race or ethnicity. The number of subjects to be enrolled will be 10, 000. This will allow us to try and maintain 200 active participants in this protocol. Volunteers are screened initially and annually by a health history questionnaire and laboratory testing to screen for bleeding or immune disorders. Participants may undergo a cytapheresis procedure every fifty-six days.

We will collect blood component cells for distribution to NIA research investigators for their studies of the immune system. We will be performing cytapheresis for the collection of 3 7 blood component packs per week. We will need to maintain an active volunteer pool of approximately 200 active volunteers.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:
  • Normal healthy males and females, age 18 years and older
  • Adequate venous access in bilateral upper extremities to accommodate at least a #18 gauge dialysis needle.
  • Willingness and ability to come to the NIA Apheresis Unit at Harbor Hospital in Baltimore for a blood collection procedure approximately every 56 days.

EXCLUSION CRITERIA:

  • Unable to verify identification of volunteer by state issued ID card, driver s license, or military ID. Participants earning greater than $600.00/year are issued a 1099 form, therefore, positive identification is required.
  • Unable to provide informed consent
  • Weight less than 110 pounds as mandated by AABB guidelines.
  • Chronic Immunosuppressive medications such as Steroids, Cellcept or Sirolimus. Steroids given for minor illness ok if taken more than 6 weeks before any cytapherisis procedure Immunosuppressive medications may not be used at the time of the cytapheresis procedure as they decrease circulating white blood cells.
  • Test results are positive for viral infections such as HIV, Hepatitis B or C and RPR. Researchers are seeking healthy, pristine cells. Due to the ongoing nature of these chronic viral and bacterial infections, the white cell populations in the peripheral blood will change. Researchers want to study changing white cell populations as a factor of aging only and not those altered by infections.
  • Ongoing risk factors for HIV or Hepatitis B or C such as: intravenous drug use, non-monogamous unprotected intercourse, or chronic use of clotting factor concentrates such as prothrombin complexes, Factor XIII or Factor VIIa. These viruses weaken the immune system and cause changes in the white blood cells.
  • Risk factors for Creutzfeldt-Jakob disease such as: a relative with the disease, received beef insulin or growth hormone from human pituitary glands, or residency/travel to high risk countries (complete list of countries located in the Cytapheresis Screening manual kept in the NIA apheresis unit). This is a transmittable infectious disease with a very long incubation period.
  • Major medical illnesses such as any type of liquid or solid tumor cancer, diabetes, history of deep vein thrombosis, organ or bone marrow transplant, or liver, kidney, heart or lung disease.
  • A medical finding that shows a participant could not safely go through this procedure. (such as Parkinson s disease, dementia or any uncontrolled behavior that would place the participant s safety at risk)
  • Major infectious diseases such as Chagas disease, babesiosis, syphilis or malaria
  • Bleeding conditions such as hemophilia or von Willebrand s disease.
  • Significant abnormalities are found in the results of blood tests such as elevated liver enzymes, abnormal kidney function, positive viral titers, fasting blood glucose greater than 120.
  • On any medication that can alter white blood cell function such as chronic steroid use, histamine-2 blockers, antivirals or chemotherapy. (complete list located in the Cytapheresis Screening manual stored in the NIA Apheresis unit).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00104325

Contacts
Contact: Julia L McKelvey, R.N. (410) 350-3929 mckelveyju@nih.gov
Contact: Josephine M Egan, M.D. (410) 558-8414 eganj@mail.nih.gov

Locations
United States, Maryland
National Institute of Aging, Clinical Research Unit Recruiting
Baltimore, Maryland, United States, 21224
Contact: NIA Studies Recruitment    410-350-3941    niastudiesrecruitment@mail.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Josephine M Egan, M.D. National Institute on Aging (NIA)
  More Information

No publications provided

Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute on Aging (NIA) )
ClinicalTrials.gov Identifier: NCT00104325     History of Changes
Other Study ID Numbers: 999903316, 03-AG-N316
Study First Received: February 24, 2005
Last Updated: October 4, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Cytapheresis
Blood Collection
Volunteer Donor
White Blood Cells

ClinicalTrials.gov processed this record on October 16, 2014