MSC and Kidney Transplant Tolerance (Phase A)

Monia Lorini

Status and phase: Unknown; Phase 1

Conditions: Chronic Renal Failure

Treatments: Biological: Mesenchymal Stromal Cells

Study type: Interventional

Funder types: Other

Identifiers

NCT02565459

2015-002186-27 (EudraCT Number)

Third-party MSC-Tx tolerance A

Details and patient eligibility

About

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).

Enrollment: 22 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

Mesenchymal Stromal Cells (MSC)

Experimental group

Description:

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.

Treatment:

Biological: Mesenchymal Stromal Cells

No intervention

No Intervention group