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MSC and Kidney Transplant Tolerance (Phase A)

Primary Purpose

Chronic Renal Failure

Status

Unknown status

Phase

Phase 1

Locations

Italy

Study Type

Interventional

Intervention

Mesenchymal Stromal Cells

About this trial

This is an interventional treatment trial for Chronic Renal Failure focused on measuring Mesenchymal stromal cells, kidney transplantation, tolerance

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

U.O. Nefrologia e DialisiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Mesenchymal Stromal Cells (MSC)

No intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of adverse events

At each visit overall clinical condition of the patient will be evaluated and any adverse event will be recorded.

Circulating naive and memory T cell count (CD45RA/CD45RO) (flow cytometry analysis)

Circulating regulatory T cell count.

T-cell function in mixed lymphocyte reaction.

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.

Urinary FOXP3 mRNA expression evaluated by real time quantitative PCR

Secondary Outcome Measures

Full Information

NCT ID

NCT02565459

First Posted

September 24, 2015

Last Updated

April 5, 2018

Sponsor

Monia Lorini

Collaborators

Mario Negri Institute for Pharmacological Research

1. Study Identification

Unique Protocol Identification Number

NCT02565459

Brief Title

MSC and Kidney Transplant Tolerance (Phase A)

Official Title

Third-party Bone Marrow-derived Mesenchymal Stromal Cells to Induce Tolerance in Recipients of Kidney Transplants From Deceased Donors (Phase A)

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Unknown status

Study Start Date

September 2015 (undefined)

Primary Completion Date

September 2021 (Anticipated)

Study Completion Date

December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Monia Lorini

Collaborators

Mario Negri Institute for Pharmacological Research

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Renal Failure

Keywords

Mesenchymal stromal cells, kidney transplantation, tolerance

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Mesenchymal Stromal Cells (MSC)

Arm Type

Experimental

Arm Description

Arm Title

No intervention

Arm Type

No Intervention

Intervention Type

Biological

Intervention Name(s)

Mesenchymal Stromal Cells

Primary Outcome Measure Information:

Title

Number of adverse events

Description

At each visit overall clinical condition of the patient will be evaluated and any adverse event will be recorded.

Time Frame

Changes from baseline through study completion, up to 12 months after transplant.

Title

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.

Title

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.

Title

T-cell function in mixed lymphocyte reaction.

Description

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.

Time Frame

Changes from baseline at 6 and 12 months after transplant.

Title

Urinary FOXP3 mRNA expression evaluated by real time quantitative PCR

Time Frame

Changes from baseline at 6 and 12 months after transplant.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Norberto Perico, MD

Phone

0039 035 45351

norberto.perico@marionegri.it

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Giuseppe Remuzzi, MD

Organizational Affiliation

A.O. Ospedale Papa Giovanni XXIII

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Norberto Perico, MD

Organizational Affiliation

Istituto Di Ricerche Farmacologiche Mario Negri

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Giovanni Rota, MD

Organizational Affiliation

A.O. Ospedale Papa Giovanni XXIII

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Federica Casiraghi

Organizational Affiliation

Istituto Di Ricerche Farmacologiche Mario Negri

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Martino Introna, MD

Organizational Affiliation

Laboratorio G. Lanzani, Bergamo, Italy

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Alessandro Rambaldi, MD

Organizational Affiliation

A.O. Ospedale Papa Giovanni XXIII

Official's Role

Principal Investigator

Facility Information:

Facility Name

U.O. Nefrologia e Dialisi

City

Bergamo

ZIP/Postal Code

24127

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Piero Ruggenenti, MD

Phone

0039 035 2674037

pruggenenti@hpg23.it

First Name & Middle Initial & Last Name & Degree

Eliana Gotti, MD

12. IPD Sharing Statement

Learn more about this trial

MSC and Kidney Transplant Tolerance (Phase A)

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