IRB Study Number 23-083
Status Recruiting
Institute Taussig Cancer Institute
Description
Primary Objectives
To collect and bank peripheral blood MNCs from healthy volunteer donors. Peripheral blood MNCs include cellular components (hematopoietic cells and immune cells) that are critical starting material for pre-clinical and clinical research on cellular therapies and immunotherapies, leading to life-saving products such as Chimeric Antigen Receptor (CAR) T-cells.
To provide a common collection procedure for healthy donors of peripheral blood stem cells, lymphocytes and other MNCs.
To establish a bank of healthy donor MNCs as a resource for investigators conducting research studies, which may include animal studies, clinical-grade (GMP-compliant) isolation, culture expansion and genetic modification. All studies using cells collected under this protocol will be described in a separate, specific protocol with IRB/IACUC approvals.
Inclusion Criteria
Donors with age at the time of donation, age ≥ 18 and ≤ 65 years of age.
Exclusion Criteria
Patients pregnant or breastfeeding at the time of donation.
Previously denied for blood donation.
Known anemia with hemoglobin lower than 11.0 g/dL.
History of transient ischemic attack or cerebrovascular accident
Active acute or chronic infection including:
a. Active acute or chronic hepatitis B
b. Active acute or chronic hepatitis C
c. History of HIV infection or AIDS
d. History of cytomegalovirus infection
e. History of infection with human T-cell lymphoma virus I/II
f. History of previous infection by Treponema pallidum
g. History of infection by West Nile Virus
h. History of Chagas disease (previous infection by Trypanosoma cruzi)
Known clinical history of coagulation abnormalities, including anticoagulants. This includes subjects taking more than 81mg of aspirin per day, receiving other antiplatelet agents or receiving oral or subcutaneous anticoagulants.
Participants, who in the view of the investigator or collection team, are not good candidates for apheresis (primarily if they do not have adequate venous access)
