Safety Study of Multipotent Progenitor Cells for Immunomodulation Therapy After Liver Transplantation

Prof. Dr. Marc-H. Dahlke, Ph. D.

Status and phase: Terminated; Phase 1

Conditions: Liver Transplantation

Treatments: Drug: MultiStem

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01841632

2009-017795-25 (EudraCT Number)

MISOT-I

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

MultiStem

Experimental group

Description:

Dose escalation Cohort 1 Drug: MultiStem, Dose 1 of MultiStem; Route and time: Two infusions; First: intra portal at liver transplantation (day 1), second: intra venous (day 3) Cohort 2 Drug: MultiStem, Dose 2 of MultiStem; Route and time: Two infusions; First: intra portal at liver transplantation (day 1), second: intra venous (day 3) Cohort 3 Drug: MultiStem, Dose 3 of MultiStem; Route and time: Two infusions; First: intra portal at liver transplantation (day 1), second: intra venous (day 3) Cohort 4 Drug: MultiStem, Dose 4 of MultiStem; Route and time: Two infusions; First: intra portal at liver transplantation (day 1), second: intra venous (day 3)

Treatment:

Drug: MultiStem