Mesenchymal Stromal Cells in Kidney Transplant Recipients

May 30, 2023 updated by: Mario Negri Institute for Pharmacological Research

Autologous Mesenchymal Stromal Cells to Induce Tolerance in Living-donor Kidney Transplant Recipients

The general aim of the present study is to test a cell therapy with autologous ex-vivo expanded mesenchymal stromal cells (MSCs) as a strategy to induce tolerance in living-donor kidney transplant recipients. MSCs will be prepared accordingly to established protocols, starting from bone marrow explants of living-donor kidney transplant recipients obtained 3-4 months before kidney transplant. From these samples, MSCs will be expanded in Good Manufacturing Practice (GMP) approved facilities and used for the present study in patients undergoing kidney transplantation.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bergamo, Italy, 24127
        • U.O. Nefrologia e Dialisi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male and female patients;
  • Aged 18 or older;
  • Living-donor (related and unrelated, spouse/husband) kidney transplant recipients;
  • Non-Human Leukocyte Antigen (HLA) identical with the donor (one or two haplotype mismatches);
  • First kidney transplant;
  • Capable of understanding the purpose and risk of the study;
  • Written informed consent.

Exclusion Criteria:

  • MSC donor positive for HIV-1, HIV-2, hepatitis B virus (HBV),hepatitis C virus (HCV), syphilis;
  • Specific contraindication to MSC infusion;
  • Any clinical relevant condition that might affect study participation and/or study results;
  • Pregnant women and nursing mothers;
  • Unwillingness or inability to follow study protocol in the investigator's opinion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mesenchymal Stromal Cells

A single intravenous infusion of ex-vivo expanded autologous MSCs will be performed in patients in addition to the living-donor kidney transplantation.

2x10 elevated to sxth power MSCs per kilogram body weight previously isolated from the same recipient will be infused intravenously the day before the kidney transplant procedure.
Biological: Mesenchymal Stromal Cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Circulating naïve and memory T cell count (CD45RA/CD45RO) (flow cytometry analysis).
Time Frame: Changes from baseline at 6 and 12 months after transplant.
Changes from baseline at 6 and 12 months after transplant.
T-cell function by ELISPOT assay in mixed lymphocyte reaction.
Time Frame: Changes from baseline at 6 and 12 months after transplant.
Changes from baseline at 6 and 12 months after transplant.
Number of adverse events.
Time Frame: Changes from baseline up to 48 months.
At each visit the overall clinical condition of the patient will be evaluated and any adverse event will be recorded.
Changes from baseline up to 48 months.
Circulating regulatory T cell count.
Time Frame: Changes from baseline at 6 and 12 months after transplant.
Changes from baseline at 6 and 12 months after transplant.
Urinary FOXP3 mRNA expression evaluated by real time quantitative PCR.
Time Frame: Changes from baseline at 6 and 12 months after transplant.
Changes from baseline at 6 and 12 months after transplant.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mario Negri Institute for Pharmacological Research

Collaborators

A.O. Ospedale Papa Giovanni XXIII

Investigators

  • Study Chair: Giuseppe Remuzzi, MD, A.O. Ospedale Papa Giovanni XXIII
  • Study Director: Norberto Perico, MD, Istituto Di Ricerche Farmacologiche Mario Negri
  • Principal Investigator: Giovanni Rota, MD, A.O. Ospedale Papa Giovanni XXIII
  • Principal Investigator: Federica Casiraghi, Istituto Di Ricerche Farmacologiche Mario Negri
  • Principal Investigator: Martino Introna, MD, Laboratorio G. Lanzani, Bergamo, Italy
  • Principal Investigator: Alessandro Rambaldi, MD, A.O. Ospedale Papa Giovanni XXIII

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 4, 2013

Primary Completion (Actual)

May 29, 2023

Study Completion (Actual)

May 29, 2023

Study Registration Dates

First Submitted

November 29, 2013

First Submitted That Met QC Criteria

December 10, 2013

First Posted (Estimated)

December 16, 2013

Study Record Updates

Last Update Posted (Actual)

June 1, 2023

Last Update Submitted That Met QC Criteria

May 30, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MSC-Tx tolerance
  • 2013-003221-29 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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