Safety Study of Multipotent Progenitor Cells for Immunomodulation Therapy After Liver Transplantation
Condition: Liver Transplantation
Intervention: MultiStem
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Liver transplantation; Allogeneic liver transplantation; Solid organ transplantation

Summary:

      MultiStem ® is a new biological product, manufactured from human stem cells obtained from
      adult bone marrow. Factors expressed by MultiStem cells are believed to regulate immune
      system function and augment tissue repair.

      Standard of care pharmacological immunosuppression after liver transplantation can achieve
      reasonable survival of liver grafts and patients. The side effects of this treatment,
      however, are clinically significant and diminish the overall success of organ transplantation
      as a curative therapy. It is therefore the objective of this study to implement cellular
      immunomodulation therapy with MultiStem as an adjunct to standard pharmacological
      immunosuppression with the ultimate goal of significantly reducing drug-based
      immunosuppression.

      As this is the first study with MultiStem in this subject population it has been designed as
      a safety and feasibility trial. However, first evidence of a potential benefit for this
      patient population will be explored cautiously.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients ≥18 years of age undergoing allogeneic liver transplantation

          -  Absence of any familial, sociological or geographical condition potentially hampering
             compliance with the study protocol and follow-up schedule

          -  Written informed consent prior to any study procedures

        Exclusion Criteria:

          -  Known allergies to bovine or porcine products or any other ingredients of the product

          -  Patients older than 65 years of age

          -  Patients listed in a high-urgency status that would not allow proper preparation of
             the study interventions

          -  Patients receiving a secondary liver graft (Re-Transplantation)

          -  Double organ transplant recipients

          -  Pre-existing renal failure that requires or has required hemodialysis within the last
             year

          -  Pulmonary function: FEV1, FVC, DLCO ≤50% predicted

          -  Cardiac function: left ventricular ejection fraction ≤50%

          -  HIV seropositive, varicella virus active infection or any other clinically relevant
             infection

          -  History of any malignancy (including lymphoproliferative disease and hepatocellular
             carcinoma) except for squamous or basal cell carcinoma of the skin that has been
             treated with no evidence of recurrence

          -  Unstable myocardium (evolving myocardial infarction), cardiogenic shock

          -  Females of childbearing potential (hormonal status and gynecological consultation
             required)

          -  Patients with portal vein thrombosis

          -  Patients with a history of pulmonary embolism