MIC Cell Therapy for Individualized Immunosuppression in Living Donor Kidney Transplant Recipients

A Single-arm Phase-I Trial for the Determination of Safety and Feasibility of the Intravenous Administration of Mitomycin C-treated Donor Peripheral Blood Mononuclear Cells (MICs) for Individualized Immunosuppression in Living Donor Kidney Transplant Recipients (TOL-1 Study)

A phase- I clinical trial to determine safety and feasibilty of intravenous administration of mitomycin C-treated donor peripheral blood mononuclear cells in patients with chronic kidney disease stage KDIGO 4 or 5 (i.e. GFR 15-30 mL/min or < 15 mL/min) who receive a kidney transplant from a living donor.

Inclusion Criteria:

• Chronic kidney disease stage KDIGO 4 or 5
• First kidney transplant from a living donor
• Age ≥ 18 years
• ABO compatible
• CDC-PRA < 20%
• No donor-specific antibodies
• Negative CDC and ELISA crossmatch
• Immunosuppression with cyclosporin A, EC-MPS and methylprednisolone
• Informed consent
• Adequate contraception (women with child bearing potential)

Exclusion Criteria:

• Psychiatric disorder
• Heart failure (NYHA III or IV)
• Severe liver disease
• Active hepatitis B or C or HIV infection
• Active bacterial, fungal or viral disease
• Malignancy or malignancy in the last 5 years before screening
• Preexisting immunosuppression
• Vaccination with a live vaccine in the last 3 months before screening
• S/p splenectomy
• Substance abuse
• Pregnancy or lactation
• Women: Child/pregnancy with the intended donor
• Allergy against the investigational drug or part of it
• Other diseases that prohibit participation in the study (in the opinion of the investigator)
• Participation in an other interventional study