MSC Therapy in Liver Transplantation

Monia Lorini

Status and phase: Enrolling; Phase 1

Conditions: Liver Transplant Rejection

Treatments: Biological: Mesenchymal Stromal Cells

Study type: Interventional

Funder types: Other

Identifiers

NCT02260375

MSC liver transplant tolerance

2014-001531-37 (EudraCT Number)

Details and patient eligibility

About

The general aim of the present study is to test a cell therapy with third-party allogeneic ex-vivo expanded MSCs as a strategy to induce tolerance in liver transplant recipients. MSCs will be prepared accordingly to established protocols , starting from diagnostic samples of bone marrow aspirates (2-5 mL) or using the remnants in the bag and filter at the end of the bone marrow infusions. From these samples, MSCs will be expanded in GMP approved facilities and used for the present study in patients undergoing liver transplantation.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

For this study, the following inclusion criteria should be fulfilled before starting withdrawal of drugs after 1 year post-transplant:

• First liver transplant
• Capable of understanding the purpose and risk of the study
• Written informed consent

Exclusion criteria

• 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 the 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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20 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 MSC (from healthy donors) will be performed in patients assigned to the MSC procedure in addition to the liver transplantation.

Treatment:

Biological: Mesenchymal Stromal Cells

No treatment.

No Intervention group