Mesenchymal Stromal Cells in Kidney Transplant Recipients

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Mario Negri Institute for Pharmacological Research
Sponsor:
Collaborator:
A.O. Ospedale Papa Giovanni XXIII
Information provided by (Responsible Party):
Mario Negri Institute for Pharmacological Research
ClinicalTrials.gov Identifier:
NCT02012153
First received: November 29, 2013
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Kidney Transplant Rejection
Biological: Mesenchymal Stromal Cells
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: AUTOLOGOUS MESENCHYMAL STROMAL CELLS TO INDUCE TOLERANCE IN LIVING-DONOR KIDNEY TRANSPLANT RECIPIENTS

Resource links provided by NLM:


Further study details as provided by Mario Negri Institute for Pharmacological Research:

Primary Outcome Measures:
  • Circulating naïve and memory T cell count (CD45RA/CD45RO) (flow cytometry analysis). [ Time Frame: Changes from baseline at 6 and 12 months after transplant. ] [ Designated as safety issue: No ]
  • T-cell function by ELISPOT assay in mixed lymphocyte reaction. [ Time Frame: Changes from baseline at 6 and 12 months after transplant. ] [ Designated as safety issue: No ]
  • Number of adverse events. [ Time Frame: Changes from baseline up to 48 months. ] [ Designated as safety issue: Yes ]
    At each visit the overall clinical condition of the patient will be evaluated and any adverse event will be recorded.

  • Circulating regulatory T cell count. [ Time Frame: Changes from baseline at 6 and 12 months after transplant. ] [ Designated as safety issue: No ]
  • Urinary FOXP3 mRNA expression evaluated by real time quantitative PCR. [ Time Frame: Changes from baseline at 6 and 12 months after transplant. ] [ Designated as safety issue: No ]

Estimated Enrollment: 6
Study Start Date: December 2013
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02012153

Contacts
Contact: Norberto Perico, MD 0039 035 45351 norberto.perico@marionegri.it

Locations
Italy
U.O. Nefrologia e Dialisi Recruiting
Bergamo, Italy, 24127
Contact: Piero Ruggenenti, MD    0039 035 2674037    pruggenenti@hpg23.it   
Sub-Investigator: Eliana Gotti, MD         
Sponsors and Collaborators
Mario Negri Institute for Pharmacological Research
A.O. Ospedale Papa Giovanni XXIII
Investigators
Study Chair: Giuseppe Remuzzi, MD A.O. Papa Giovanni XXIII, Bergamo, Italy
Study Director: Norberto Perico, MD IRCCS Istituto di Ricerche Farmacologiche Mario Negri
Principal Investigator: Giovanni Rota, MD A.O. Papa giovanni XXIII, Bergamo, Italy
Principal Investigator: Federica Casiraghi IRCCS Istituto di Ricerche Farmacologiche Mario Negri
Principal Investigator: Martino Introna, MD Laboratorio G. Lanzani, Bergamo, Italy
Principal Investigator: Alessandro Rambaldi, MD A.O. Papa Giovanni XXIII, Bergamo, Italy
  More Information

No publications provided

Responsible Party: Mario Negri Institute for Pharmacological Research
ClinicalTrials.gov Identifier: NCT02012153     History of Changes
Other Study ID Numbers: MSC-Tx tolerance, 2013-003221-29
Study First Received: November 29, 2013
Last Updated: July 21, 2014
Health Authority: Italy: National Institute of Health
Italy: Italian Medicines Agency

Keywords provided by Mario Negri Institute for Pharmacological Research:
Mesenchymal stromal cells
Kidney transplantation
Tolerance

ClinicalTrials.gov processed this record on September 30, 2014