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
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Renal Failure focused on measuring Mesenchymal stromal cells, kidney transplantation, tolerance
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.
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
No
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
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.
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
No
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
Email
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
Email
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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