Cell therapy to improve liver transplant outcomes
THIRD-PARTY BONE MARROW-DERIVED MESENCHYMAL STROMAL CELLS TO INDUCE TOLERANCE IN LIVER TRANSPLANT RECIPIENTS
This study is testing if using special cells from bone marrow can help people who are getting their first liver transplant avoid rejection and have better outcomes.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | A.O. Ospedale Papa Giovanni XXIII Academic / other |
| Locations | 6 sites (Bergamo and 5 other locations) |
| Trial ID | NCT02260375 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the use of mesenchymal stromal cells (MSCs) as a cell therapy to promote tolerance in patients receiving their first liver transplant. The MSCs will be derived from bone marrow samples and expanded in a controlled environment before being administered to participants. The goal is to determine if this approach can reduce the risk of liver transplant rejection and improve patient outcomes. Participants will be monitored for their response to the treatment over a specified period.
Who should consider this trial
Good fit: Ideal candidates are individuals undergoing their first liver transplant who are capable of providing informed consent.
Not a fit: Patients with contraindications to MSC infusion or those with significant clinical conditions affecting participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could enhance liver transplant acceptance and reduce the need for long-term immunosuppressive medications.
How similar studies have performed: While the use of MSCs in transplantation is a growing area of interest, this specific approach is relatively novel and has not been extensively tested in liver transplantation.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Bergamo and 5 other locations
- U.S.C Nefrologia e Dialisi — Bergamo, Italy (Recruiting)
- USC Chirurgia Generale III — Bergamo, Italy (Recruiting)
- USC Ematologia — Bergamo, Italy (Recruiting)
- USC Gastroenterologia — Bergamo, Italy (Recruiting)
- Servizio di Immunoematologia e Medicina Trasfusionale — Bologna, Italy (Recruiting)
- Unità Chirurgia Generale e Trapianti — Bologna, Italy (Recruiting)
Study contacts
- Principal investigator: Michele Colledan, MD — A.O. Ospedale Papa Giovanni XXIII
- Study coordinator: Giuseppe Remuzzi, MD
- Email: gremuzzi@hpg23.it
- Phone: 0039 0352674037
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.