MIC Cell Therapy for Individualized Immunosuppression in Living Donor Kidney Transplant Recipients (TOL-1)

Heidelberg University

Status and phase

Completed

Phase 1

Conditions

Kidney Failure, Chronic

Treatments

Biological: Mitomycin C-induced peripheral blood mononuclear cells (MICs)

Study type

Interventional

Funder types

Other

Identifiers

NCT02560220

TOL-1

Details and patient eligibility

About

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.

Enrollment

14 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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