Primary Objectives: ? To evaluate achievement of induction of functional immune tolerance by cellular immunotherapy with MDR-101 in recipients of human leukocyte an tigen (HLA)-matched, living donor kidney transplants. Functional immune tolerance is defined as remaining off of all immunosuppression (IS) drugs for 24 months or more after completion of anti-rejection, IS drug therapy withdrawal with no episodes of biopsy-proven acute rejection (BPAR), de novo donor-specific anti-HLA antibody (dnDSA) development, transplant kidney loss, or subject death. ? To compare the safety and tolerability of cellular immunotherapy with MDR-101 compared to conventional, standard-of-care (SOC) IS therapy in recipients of HLA-matched, living donor kidney transplants.
MDR-101 is intended to induce mixed lymphohematopoietic chimerism and donor specific immune tolerance in order to preserve transplant kidney function, avert transplant kidney rejection, and eliminate the cumulative and serious side effects associated with IS drugs.
III - Research Studies that gather more information about a drug's safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. These studies typically involve more participants.
University of Colorado Hospital
Alexander Wiseman, MD
Protocol Number: 17-1730
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