Safety and Feasibility of Multipotent Adult Progenitor Cells for Immunomodulation Therapy After Liver Transplantation: A Phase I Study of the MiSOT Study Consortium
18 Years
65 Years
Both
Liver Transplantation
Trial Information
Safety and Feasibility of Multipotent Adult Progenitor Cells for Immunomodulation Therapy After Liver Transplantation: A Phase I Study of the MiSOT Study Consortium
Inclusion Criteria:
- Patients ≥18 years of age undergoing allogeneic liver transplantation from a
cadaveric donor
- 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)
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Infusional and acute toxicity, using toxicity scoring mechanism
Outcome Description:
For the description of intraportal toxicity a doppler ultrasound examination will be performed to assess various parameters that describe velocity of flow and flow pattern. For pulmonary toxicity the assessment begins with an arterial blood gas. If this reveals pathological findings, a chest X-ray is required for clinical reasons independent of the study enrolment. In addition, clinical data describing the need for postoperative re-intubation will be recorded and the patient is assessed for the occurrence of a pulmonary embolism according to clinical guidelines. For systemic toxicity, the occurrence of anaphylactic shock due to standard clinical guidelines is recorded.
Outcome Time Frame:
up to day 30 (+10)
Safety Issue:
Yes
Authority:
Germany: Paul-Ehrlich-Institut
Study ID:
MISOT-I
NCT ID:
NCT01841632
Start Date:
April 2013
Completion Date:
March 2016
Related Keywords:
- Liver Transplantation
- Liver transplantation
- Allogeneic liver transplantation
- Solid organ transplantation
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