Collection of Peripheral Blood Mononuclear Cells (PBMCs) From Healthy People for the Expansion of… (NCT02821806) | Clinical Trial Compass
RecruitingNot Applicable
Collection of Peripheral Blood Mononuclear Cells (PBMCs) From Healthy People for the Expansion of T Cells for Adoptive Cell Therapy
United States500 participantsStarted 2016-08-08
Plain-language summary
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.
Who can participate
Age range
18 Years – 120 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* INCLUSION CRITERIA:
* Age greater than or equal to 18 years old and able to give consent.
* Adequate clinical parameters (all of the following):
* Afebrile (temperature less than or equal to 37.5 degree C)
* Systolic blood pressure less than or equal to180 mmHg
* Diastolic blood pressure less than or equal to100 mmHg
* Weight greater than or equal to 110 lbs.
* Heart rate between 50-100 beats/minute
* Adequate bilateral antecubital venous access for a 2 arm apheresis procedure
* Females of child-bearing potential should not be pregnant or breast-feeding.
* 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)
* Within 30 days of pheresis donation, donor must have:
* Hemoglobin:
* Women greater than or equal to 12.5 gm/dL
* Men greater than or equal to 13.0 gm/dL
* Platelets greater than or equal to 100,000/microliter
* Total WBC greater than or equal to 2 K/microliter
EXCLUSION CRITERIA:
* History of medical illness that in the estimation of the PI or DTM physician precludes donation of PBMCs.
* Current psychiatric diagnosis that would compromise compliance with donation or precludes appropriate informed consent.
* Presence of any blood transmissible infectious disease that cannot be cleared prior to PBMC donation and poses an unacceptable risk for the recipient.
* Active malignancy will ex…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Collection PBMCs from healthy subjects to use for the expansion ofautologous T cells from patients with cancer
Timeframe: ongoing
2
Improve and develop new methods to isolate PBMCs and to expand T cells for adoptive cellular therapy