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)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02560220

Acronym

TOL-1

Enrollment

Registered

2015-09-25

Start date

2015-08-05

Completion date

2017-04-18

Last updated

2018-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Failure, Chronic

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.

Interventions

BIOLOGICALMitomycin C-induced peripheral blood mononuclear cells (MICs)

MICs are given intravenously 2 or 7 days before kidney transplantation from a living donor

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
The primary outcome measure is the frequency of adverse events after intravenous administration of MICs within 30 days after transplantation.	30 days

Secondary

Measure	Time frame
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
Cumulative incidence of infection	30 days
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
Number of patients with DSA	day -1 before transplantation and day 7 and 30 after transplantation

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026