Allogeneic Regulatory Dendritic Cell (DCreg) Renal Study

Inclusion Criteria

• •Donor Eligibility Criteria:
• •Able to understand and provide informed consent;
• •Male or female \>/= 18 years of age
• •Meets all standard institutional criteria for kidney donation and Health Agency criteria for kidney donation;
• •For females of childbearing potential, a negative urine or serum pregnancy test;
• •Negative for Human Immunodeficiency Virus type 1 (HIV) -1 (antigen and Nucleic Acid Testing (NAT)), HIV-2, Human T-cell leukemia virus type 1 (HTLV-1), and HTLV-2;
• •Negative for hepatitis C (antibody and NAT), hepatitis B (surface antigen and core antibody), and Treponema pallidum infection;
• •Negative for West Nile Virus;
• •Negative health history for Creutzfeldt-Jakob disease;
• •No live vaccines within 8 weeks prior to leukapheresis;
• •No medical condition(s) that the investigator deems incompatible with participation in the trial; and
• •No use of investigational drugs within 12 weeks of participation.
• •Must be able to understand and provide informed consent;
• •Is \>/= 18 years old at the time of informed consent;
• •Is undergoing a living donor renal transplant;
• •For females of childbearing potential, a negative urine or serum pregnancy test upon study entry
• •The candidate agrees to use contraception with a method that is more than 80% effective (see FDA Office of Women's Health (http://www.fda.gov/birthcontrol). Female participants of child-bearing potential must consult with their physician and determine the most suitable method(s) to be used from one month before study treatment begins until one month after study completion;
• •Cytomegalovirus (CMV) seropositive or, if CMV seronegative must be receiving a kidney from a CMV seronegative donor;
• •Has a negative purified protein derivative (PPD) or negative testing for tuberculosis using an approved IGRA blood test, such as QuantiFERON®-Gold TB or T-SPOT-TB assay OR has completed treatment for latent tuberculosis and has a negative chest x-ray. PPD or IGRA testing must occur within 52 weeks before transplant. These requirements apply as well to prior recipients of Bacille Calmette-Guérin (BCG) vaccination;
• •Meets all standard institutional and Health Agency criteria for kidney transplant.
• •Vaccines up to date as per DAIT guidance for patients in transplant trials (Refer to Manual of Operations).