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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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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.
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