MIC Cell Therapy for Individualized Immunosuppression in Living Donor Kidney Transplant Recipients
Phase 1
Completed
- Conditions
- Kidney Failure, Chronic
- Interventions
- Biological: Mitomycin C-induced peripheral blood mononuclear cells (MICs)
- Registration Number
- NCT02560220
- Lead Sponsor
- Heidelberg University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intervention arm Mitomycin C-induced peripheral blood mononuclear cells (MICs) Patients receive MIC cell therapy together with standard immunosuppressive therapy
- Primary Outcome Measures
Name Time Method The primary outcome measure is the frequency of adverse events after intravenous administration of MICs within 30 days after transplantation. 30 days
- Secondary Outcome Measures
Name Time Method Cumulative incidence of infection 30 days Cumulative incidence of CMV reactivation 30 days Number of patients with PTLD 30 days Number of patients with delayed graft function 7 days Number of patients with a pos. CDC and/or ELISA crossmatch day -1 before transplantation Number of patients with DSA day -1 before transplantation and day 7 and 30 after transplantation Incidence of biopsy-proven cellular rejection 30 days Incidence of biopsy-proven antibody-mediated rejection 30 days Number of patients with stable graft function (S-creatinine < 2mg/dL) 30 days Patient and graft survival 30 days
Trial Locations
- Locations (1)
University of Heidelberg
🇩🇪Heidelberg, Baden-Wuerttemberg, Germany