Mesenchymal Stromal Cells in Kidney Transplant Recipients

Mario Negri Institute for Pharmacological Research

Status and phase: Terminated; Phase 1

Conditions: Kidney Transplant Rejection

Treatments: Biological: Mesenchymal Stromal Cells

Study type: Interventional

Funder types: Other

Identifiers

NCT02012153

MSC-Tx tolerance

2013-003221-29 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

Mesenchymal Stromal Cells

Experimental group

Description:

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.

Treatment:

Biological: Mesenchymal Stromal Cells