NCT02012153

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Dec 2013

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

November 29, 2013

Completed
5 days until next milestone

Study Start

First participant enrolled

December 4, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 16, 2013

Completed
9.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 29, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 29, 2023

Completed
Last Updated

June 1, 2023

Status Verified

May 1, 2023

Enrollment Period

9.5 years

First QC Date

November 29, 2013

Last Update Submit

May 30, 2023

Conditions

Kidney Transplant Rejection

Keywords

Mesenchymal stromal cellsKidney transplantationTolerance

Outcome Measures

Primary Outcomes (5)

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

    Changes from baseline at 6 and 12 months after transplant.

  • T-cell function by ELISPOT assay in mixed lymphocyte reaction.

    Changes from baseline at 6 and 12 months after transplant.

  • Number of adverse events.

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

    Changes from baseline up to 48 months.

  • Circulating regulatory T cell count.

    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 (1)

Mesenchymal Stromal Cells

EXPERIMENTAL

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

Interventions

Mesenchymal Stromal CellsBIOLOGICAL
Mesenchymal Stromal Cells

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

U.O. Nefrologia e Dialisi

Bergamo, 24127, Italy

Location

Related Publications (1)

  • Perico N, Casiraghi F, Todeschini M, Cortinovis M, Gotti E, Portalupi V, Mister M, Gaspari F, Villa A, Fiori S, Introna M, Longhi E, Remuzzi G. Long-Term Clinical and Immunological Profile of Kidney Transplant Patients Given Mesenchymal Stromal Cell Immunotherapy. Front Immunol. 2018 Jun 14;9:1359. doi: 10.3389/fimmu.2018.01359. eCollection 2018.

    PMID: 29963053DERIVED

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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2013

First Posted

December 16, 2013

Study Start

December 4, 2013

Primary Completion

May 29, 2023

Study Completion

May 29, 2023

Last Updated

June 1, 2023

Record last verified: 2023-05

Locations

IT(1)