MSC and Kidney Transplant Tolerance (Phase A)

NCT ID: NCT02565459

Last Updated: 2018-04-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2021-12-31

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).

Conditions

Chronic Renal Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mesenchymal Stromal Cells (MSC)

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.

Group Type: EXPERIMENTAL

Mesenchymal Stromal Cells

Intervention Type: BIOLOGICAL

No intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Mesenchymal Stromal Cells

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mario Negri Institute for Pharmacological Research

OTHER

Sponsor Role: collaborator

Monia Lorini

OTHER

Sponsor Role: lead

Responsible Party

Monia Lorini

EC Secretary

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Giuseppe Remuzzi, MD

Role: STUDY_CHAIR

A.O. Ospedale Papa Giovanni XXIII

Norberto Perico, MD

Role: STUDY_DIRECTOR

Istituto Di Ricerche Farmacologiche Mario Negri

Giovanni Rota, MD

Role: PRINCIPAL_INVESTIGATOR

A.O. Ospedale Papa Giovanni XXIII

Federica Casiraghi

Role: PRINCIPAL_INVESTIGATOR

Istituto Di Ricerche Farmacologiche Mario Negri

Martino Introna, MD

Role: PRINCIPAL_INVESTIGATOR

Laboratorio G. Lanzani, Bergamo, Italy

Alessandro Rambaldi, MD

Role: PRINCIPAL_INVESTIGATOR

A.O. Ospedale Papa Giovanni XXIII

Locations

U.O. Nefrologia e Dialisi

Bergamo, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Norberto Perico, MD

Role: CONTACT

norberto.perico@marionegri.it

0039 035 45351

Facility Contacts

Piero Ruggenenti, MD

Role: primary

pruggenenti@hpg23.it

0039 035 2674037

Other Identifiers

2015-002186-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

Third-party MSC-Tx tolerance A

Identifier Type: -

Identifier Source: org_study_id