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MSC and Kidney Transplant Tolerance (Phase A)

NCT02565459 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2018-04-06

No results posted yet for this study

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).

Conditions

  • Chronic Renal Failure

Interventions

BIOLOGICAL

Mesenchymal Stromal Cells

Sponsors & Collaborators

  • Mario Negri Institute for Pharmacological Research

    collaborator OTHER

  • Monia Lorini

    lead OTHER

Principal Investigators

  • Giuseppe Remuzzi, MD · A.O. Ospedale Papa Giovanni XXIII

  • Norberto Perico, MD · Istituto Di Ricerche Farmacologiche Mario Negri

  • Giovanni Rota, MD · A.O. Ospedale Papa Giovanni XXIII

  • Federica Casiraghi · Istituto Di Ricerche Farmacologiche Mario Negri

  • Martino Introna, MD · Laboratorio G. Lanzani, Bergamo, Italy

  • Alessandro Rambaldi, MD · A.O. Ospedale Papa Giovanni XXIII

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2021-09-30
Completion
2021-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02565459 on ClinicalTrials.gov