MSC Therapy in Liver Transplantation

Liver Transplant Rejection Clinical Trial

Official title:

THIRD-PARTY BONE MARROW-DERIVED MESENCHYMAL STROMAL CELLS TO INDUCE TOLERANCE IN LIVER TRANSPLANT RECIPIENTS

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02260375
• Other study ID #: MSC liver transplant tolerance
• Secondary ID: 2014-001531-37
• Status: Recruiting
• Phase: Phase 1
• First received: October 6, 2014
• Last updated: April 5, 2018
• Start date: October 2014
• Est. completion date: October 2025

Study information

• Verified date: April 2018
• Source: A.O. Ospedale Papa Giovanni XXIII
• Contact: Giuseppe Remuzzi, MD
• Phone: 0039 0352674037
• Email: gremuzzi[@]hpg23.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 2025
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Liver Transplant Rejection

Intervention

Biological:
• Mesenchymal Stromal Cells

Locations

Country	Name	City	State
Italy	U.S.C Nefrologia e Dialisi	Bergamo
Italy	USC Chirurgia Generale III	Bergamo
Italy	USC Ematologia	Bergamo
Italy	USC Gastroenterologia	Bergamo
Italy	Servizio di Immunoematologia e Medicina Trasfusionale	Bologna
Italy	Unità Chirurgia Generale e Trapianti	Bologna

Sponsors (2)

Lead Sponsor	Collaborator
Monia Lorini	Mario Negri Institute for Pharmacological Research

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of adverse events	At each visit overall clinical condition of the patient will be evaluated and any adverse event will be recorded.	Changes from baseline up to 120 month.
Primary	Liver tissue mRNA level of Transferrin receptor CD71 (TFRC) and Hepcidin antimicrobial peptide (HAMP) genes		At 12 and 60 month.
Primary	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.
Primary	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.