Status:
TERMINATED
Safety Study of Multipotent Progenitor Cells for Immunomodulation Therapy After Liver Transplantation
Lead Sponsor:
Prof. Dr. Marc-H. Dahlke, Ph. D.
Collaborating Sponsors:
University Hospital Regensburg
Healios K.K.
Conditions:
Liver Transplantation
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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 au...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT01841632
Start Date
April 1 2013
End Date
December 1 2016
Last Update
August 17 2018
Active Locations (1)
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1
Department of Surgery, University Hospital Regensburg
Regensburg, Bavaria, Germany, 93053