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

NCT02560220 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2018-07-26

No results posted yet for this study

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.

Conditions

  • Kidney Failure, Chronic

Interventions

BIOLOGICAL

Mitomycin C-induced peripheral blood mononuclear cells (MICs)

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

Sponsors & Collaborators

  • WiSP GmbH

    collaborator OTHER

  • German Federal Ministry of Economics and Technology

    collaborator OTHER_GOV

  • Heidelberg University

    lead OTHER

Principal Investigators

  • Martin Zeier, MD · Heidelberg University

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-05
Primary Completion
2017-04-18
Completion
2017-04-18

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02560220 on ClinicalTrials.gov