Allogeneic Regulatory Dendritic Cell (DCreg) Renal Study

Eligibility Criteria

• * Able to understand and provide informed consent;
• * Meets all standard institutional criteria for kidney donation and Health Agency compliance with kidney donation regulations;
• * For females of childbearing potential, a negative urine or serum pregnancy test;
• * Negative for tuberculosis by either a negative:
• * Purified Protein Derivative (PPD) test or
• * Result using an approved interferon-gamma release assay (IGRA) blood test, such as QuantiFERON®-Gold TB or T-SPOT.TB assay,
• * Unless the participant has completed treatment for latent tuberculosis, and has a negative chest x-ray.
• * Note:
• 1. PPD or IGRA testing documented to have been performed within 52 weeks before transplant is acceptable
• 2. Prior recipients of a Bacille Calmette-Guérin (BCG) vaccination must follow the same requirements
• * 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 risk factors related to Zika Virus and 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.
• * Panel Reactive Antibody (PRA \>20%);
• * Positive T or B Cell Flow Crossmatch prior to transplant;
• * Presence of donor specific antibody (DSA) ≥ to mean fluorescence intensity (MFI) of 1000, or DSA between 500 and 1000, if a specific shared epitope pattern is present;
• * Recipient of multi-organ transplant;
• * Any prior renal or extra-renal transplant;
• * Epstein-Barr Virus (EBV) Immunoglobulin G (IgG) seronegative status;
• * Seropositivity for HIV-1, hepatitis B core antigen, or hepatitis C virus (HCV) antibody (if hepatitis C antibody positive, confirm negative infection by HCV RNA), or positivity for hepatitis B surface antigen;
• * History of malignancy other than non-melanomatous skin cancer;
• * High risk for recurrence of renal disease:
• * Hemolytic Uremic Syndrome Thrombotic Thrombocytopenic Purpura (HUS-TTP),
• * Focal Segmental Glomerular Sclerosis (FSGS), or
• * Aggressive native kidney disease.
• * Significant coronary artery disease, Ejection Fraction \<30% or prior acute myocardial infarction;
• * Compensated and decompensated cirrhosis of liver and/or portal hypertension;
• * Chronic Obstructive Pulmonary Disease requiring nasal oxygen, and/or pulmonary hypertension (mean pulmonary pressure \>45mm/hg);
• * Any history of stroke with neurological deficit;
• * Any condition that, in the opinion of the investigator, confers excessive risk for participation in this phase 1 study;
• * Presence of a condition that requires treatment with an immunosuppressive agent, other than a physiologic dose of corticosteroid;
• * Live vaccines within 8 weeks prior to transplant;
• * Use of investigational drugs within 12 weeks of participation;
• * Women receiving a kidney from a man who has fathered her child(ren), whether or not carried to term; or
• * Women receiving a kidney from her biological child.