RECRUITING

Collection of Peripheral Blood Mononuclear Cells (PBMCs) From Healthy People for the Expansion of T Cells for Adoptive Cell Therapy

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Conditions

Healthy VolunteerNormal VolunteerDonationAdoptive T Cell TherapiesPeripheral Blood Mononuclear CellsNatural History

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Title: Collection of Peripheral Blood Mononuclear Cells (PBMCs) from Healthy People for the Expansion of T Cells for Adoptive Cell Therapy Background: New therapies are being developed that use a person s own immune system to fight tumors. Some of the tumors being studied include cancers caused by viruses. Researchers want to use the healthy cells of volunteers to perform research studies. To do this, they are collecting lymphocytes through leukapheresis. Objectives: To collect healthy cells from volunteers for research studies for new cancer therapies. Eligibility: Healthy people ages 18 and older Design: Participants will be screened with a standard donor questionnaire. It asks about their health and past medical problems. It also asks about risky behaviors that could increase their exposure to viruses or bacteria that could be transmitted through a transfusion. Participants will give a blood sample to make sure they are able to donate. They will have a physical exam. A finger stick test will check their hemoglobin, or red blood cell, level. They might give a urine sample. Participants will undergo apheresis. For this, a needle is placed in a vein in each of their arms. Their blood is taken from one arm. A machine separates the white cells from the red cells and plasma by a spinning process. The white cells are removed and directed into a plastic bag. The red cells and plasma are returned through the needle in the other arm. The entire procedure takes 4 6 hours. Participants may donate every 21 days in this protocol if they choose to. ...

Official Title

Collection of Peripheral Blood Mononuclear Cells (PBMCs) From Healthy Subjects for the Expansion of T Cells for Adoptive Cell Therapy

Quick Facts

Study Start:2016-08-08
Study Completion:2035-02-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02821806

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 120 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age greater than or equal to 18 years old and able to give consent.
  2. * Adequate clinical parameters (all of the following):
  3. * Afebrile (temperature less than or equal to 37.5 degree C)
  4. * Systolic blood pressure less than or equal to180 mmHg
  5. * Diastolic blood pressure less than or equal to100 mmHg
  6. * Weight greater than or equal to 110 lbs.
  7. * Heart rate between 50-100 beats/minute
  8. * Adequate bilateral antecubital venous access for a 2 arm apheresis procedure
  9. * Females of child-bearing potential should not be pregnant or breast-feeding.
  10. * Within 30 days of pheresis donation, donors must be negative for infectious disease work-up: Antibody screen for Hepatitis B, Hepatitis C; HIV, HTLV-I/II, T. cruzi (Chagas agent), West Nile, and syphilis (RPR)
  11. * Within 30 days of pheresis donation, donor must have:
  12. * Hemoglobin:
  13. * Women greater than or equal to 12.5 gm/dL
  14. * Men greater than or equal to 13.0 gm/dL
  15. * Platelets greater than or equal to 100,000/microliter
  16. * Total WBC greater than or equal to 2 K/microliter
  1. * History of medical illness that in the estimation of the PI or DTM physician precludes donation of PBMCs.
  2. * Current psychiatric diagnosis that would compromise compliance with donation or precludes appropriate informed consent.
  3. * Presence of any blood transmissible infectious disease that cannot be cleared prior to PBMC donation and poses an unacceptable risk for the recipient.
  4. * Active malignancy will exclude the donor. Any history of malignancy will be considered on a case by case basis in accordance with NIH/DTM criteria.
  5. * If the participant answers Yes to any initial screening question, the participant will be considered ineligible.
  6. * If the participant is deferred according to DTM Cellular Therapy Screening Standard Operating Procedures (SOP), the participant will be considered ineligible.

Contacts and Locations

Study Contact

Laura A Parsons-Wandell, R.N.
CONTACT
(240) 858-7480
laura.parsons-wandell@nih.gov
Scott M Norberg, D.O.
CONTACT
(301) 275-9668
scott.norberg@nih.gov

Principal Investigator

Scott M Norberg, D.O.
PRINCIPAL_INVESTIGATOR
National Cancer Institute (NCI)

Study Locations (Sites)

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

Sponsor: National Cancer Institute (NCI)

  • Scott M Norberg, D.O., PRINCIPAL_INVESTIGATOR, National Cancer Institute (NCI)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-08-08
Study Completion Date2035-02-01

Study Record Updates

Study Start Date2016-08-08
Study Completion Date2035-02-01

Terms related to this study

Keywords Provided by Researchers

  • Normal Volunteer
  • Donation
  • Adoptive T Cell Therapies
  • Peripheral Blood Mononuclear Cells
  • Natural History

Additional Relevant MeSH Terms

  • Healthy Volunteer