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MSC and Kidney Transplant Tolerance (Phase A)

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ClinicalTrials.gov Identifier: NCT02565459
Recruitment Status : Recruiting
First Posted : October 1, 2015
Last Update Posted : April 6, 2018
Sponsor:
Collaborator:
Mario Negri Institute for Pharmacological Research
Information provided by (Responsible Party):
Monia Lorini, A.O. Ospedale Papa Giovanni XXIII

Brief Summary:

The general aim of the present study is to test a cell therapy with third-party ex-vivo expanded bone marrow-derived mesenchymal stromal cells (MSCs) as a strategy to induce tolerance in kidney transplant recipients with a deceased donor. MSCs will be prepared accordingly to established protocols, starting from the remnants in the bag and filter at the end of the bone marrow infusions. 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.

The proposed study will be developed in two phases: i) a pilot explorative safety/biologic-mechanistic phase (Phase A), ii) a pilot efficacy phase (Phase B).


Condition or disease Intervention/treatment Phase
Chronic Renal Failure Biological: Mesenchymal Stromal Cells Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Third-party Bone Marrow-derived Mesenchymal Stromal Cells to Induce Tolerance in Recipients of Kidney Transplants From Deceased Donors (Phase A)
Study Start Date : September 2015
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Mesenchymal Stromal Cells (MSC)
A single intravenous infusion (1-2 millions of MSCs per kilogram body weight) of ex-vivo expanded third-party (from healthy donors) MSCs will be performed in patients randomized to the MSC procedure in addition to the kidney transplantation.
Biological: Mesenchymal Stromal Cells
No Intervention: No intervention



Primary Outcome Measures :
  1. Number of adverse events [ Time Frame: Changes from baseline through study completion, up to 12 months after transplant. ]
    At each visit overall clinical condition of the patient will be evaluated and any adverse event will be recorded.

  2. Circulating naive and memory T cell count (CD45RA/CD45RO) (flow cytometry analysis) [ Time Frame: Changes from baseline at 7, 14, 30 days after transplant and then every six months through study completion, up to 12 months after transplant. ]
  3. Circulating regulatory T cell count. [ Time Frame: Changes from baseline at 7, 14, 30 days after transplant and then every six months through study completion, up to 12 months after transplant. ]
  4. T-cell function in mixed lymphocyte reaction. [ Time Frame: Changes from baseline at 6 and 12 months after transplant. ]
    IFNg-producing T cells (spots/300.000 cells) and CD8+ T cell-mediated cytotoxicity (percentage of specific lysis) will be measured in mixed lymphocyte reaction.

  5. Urinary FOXP3 mRNA expression evaluated by real time quantitative PCR [ Time Frame: Changes from baseline at 6 and 12 months after transplant. ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • First single kidney transplant;
  • Capable of understanding the purpose and risk of the study;
  • Written informed consent.

Exclusion Criteria:

  • PRA >10%;
  • Specific contraindication to MSC infusion;
  • Any clinical relevant condition that might affect study participation and/or study results;
  • Childbearing potential without effective contraception;
  • Pregnant women and nursing mothers;
  • Unwillingness or inability to follow study protocol in the investigator's opinion.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02565459


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
Monia Lorini
Mario Negri Institute for Pharmacological Research
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

Responsible Party: Monia Lorini, EC Secretary, A.O. Ospedale Papa Giovanni XXIII
ClinicalTrials.gov Identifier: NCT02565459     History of Changes
Other Study ID Numbers: Third-party MSC-Tx tolerance A
2015-002186-27 ( EudraCT Number )
First Posted: October 1, 2015    Key Record Dates
Last Update Posted: April 6, 2018
Last Verified: April 2018

Keywords provided by Monia Lorini, A.O. Ospedale Papa Giovanni XXIII:
Mesenchymal stromal cells
kidney transplantation
tolerance

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic