NCT02565459

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2015

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

September 24, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 1, 2015

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

April 6, 2018

Status Verified

April 1, 2018

Enrollment Period

6 years

First QC Date

September 24, 2015

Last Update Submit

April 5, 2018

Conditions

Chronic Renal Failure

Keywords

Mesenchymal stromal cellskidney transplantationtolerance

Outcome Measures

Primary Outcomes (5)

  • Number of adverse events

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

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

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

    Changes from baseline at 7, 14, 30 days after transplant and then every six months through study completion, up to 12 months after transplant.

  • Circulating regulatory T cell count.

    Changes from baseline at 7, 14, 30 days after transplant and then every six months through study completion, up to 12 months after transplant.

  • 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.

    Changes from baseline at 6 and 12 months after transplant.

  • Urinary FOXP3 mRNA expression evaluated by real time quantitative PCR

    Changes from baseline at 6 and 12 months after transplant.

Study Arms (2)

Mesenchymal Stromal Cells (MSC)

EXPERIMENTAL

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

Interventions

Mesenchymal Stromal CellsBIOLOGICAL
Mesenchymal Stromal Cells (MSC)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

U.O. Nefrologia e Dialisi

Bergamo, 24127, Italy

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Giuseppe Remuzzi, MD

    A.O. Ospedale Papa Giovanni XXIII

    STUDY CHAIR

  • Norberto Perico, MD

    Istituto Di Ricerche Farmacologiche Mario Negri

    STUDY DIRECTOR

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Norberto Perico, MD

CONTACT

0039 035 45351norberto.perico@marionegri.it

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
EC Secretary

Study Record Dates

First Submitted

September 24, 2015

First Posted

October 1, 2015

Study Start

September 1, 2015

Primary Completion

September 1, 2021

Study Completion

December 1, 2021

Last Updated

April 6, 2018

Record last verified: 2018-04

Locations

IT(1)