MSC Therapy in Liver Transplantation

Phase 1

Recruiting

• Conditions: Liver Transplant Rejection
• Interventions: Biological: Mesenchymal Stromal Cells

• Registration Number: NCT02260375
• Lead Sponsor: Monia Lorini

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-06
• Study First Submitted QC: 2014-10-08
• Study First Posted: 2014-10-09
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-05
• Last Update Posted: 2018-04-06
• Primary Completion: 2024-10
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mesenchymal Stromal Cells (MSC)	Mesenchymal Stromal Cells	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.

Primary Outcome Measures

Name	Time	Method
Circulating naive and memory T cell conts (CD45RA/CD45RO)(flow cytometry analysis)	Changes from baseline at 6 and 12 months after transplant, then every 6 months till the first 3 years after transplant and then yearly up to 120 month.
Number of adverse events	Changes from baseline up to 120 month.	At each visit overall clinical condition of the patient will be evaluated and any adverse event will be recorded.
Liver tissue mRNA level of Transferrin receptor CD71 (TFRC) and Hepcidin antimicrobial peptide (HAMP) genes	At 12 and 60 month.
T-cell function in mixed lymphocyte reaction	Changes from baseline at 6 and 12 months after transplant, then every 6 months till the first 3 years after transplant and then yearly up to 120 month.

Trial Locations

Locations (6)

USC Chirurgia Generale III; 🇮🇹 Bergamo, Italy

USC Ematologia; 🇮🇹 Bergamo, Italy

Servizio di Immunoematologia e Medicina Trasfusionale; 🇮🇹 Bologna, Italy

U.S.C Nefrologia e Dialisi; 🇮🇹 Bergamo, Italy

USC Gastroenterologia; 🇮🇹 Bergamo, Italy

Unità Chirurgia Generale e Trapianti; 🇮🇹 Bologna, Italy