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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-05

Study Completion Date

2017-04-18

Brief Summary

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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.

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Detailed Description

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Conditions

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Kidney Failure, Chronic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention arm

Patients receive MIC cell therapy together with standard immunosuppressive therapy

Group Type EXPERIMENTAL

Mitomycin C-induced peripheral blood mononuclear cells (MICs)

Intervention Type BIOLOGICAL

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

Interventions

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Mitomycin C-induced peripheral blood mononuclear cells (MICs)

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No