Safety Study of Multipotent Progenitor Cells for Immunomodulation Therapy After Liver Transplantation
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.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Safety and Feasibility of Multipotent Adult Progenitor Cells for Immunomodulation Therapy After Liver Transplantation: A Phase I Study of the MiSOT Study Consortium|
- Infusional and acute toxicity, using toxicity scoring mechanism [ Time Frame: up to day 30 (+10) ] [ Designated as safety issue: Yes ]
- 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.
- Time to first biopsy-proven acute rejection [ Time Frame: up to day 90 (+/-30) ] [ Designated as safety issue: No ]Per protocol biopsies will be performed on days 1, 4, 10. Additional biopsies will be taken whenever clinically necessary.
- Evidence confirming that MultiStem does not promote malignant transformation or tumor growth [ Time Frame: up to day 365 (+/-30) ] [ Designated as safety issue: Yes ]Four additional outpatient visits are planned to further evaluate the study patients (including screening for malignancies).
- Evaluation of data from routine examinations following last study visit for evidence of long term safety from MultiStem administration [ Time Frame: up to six years ] [ Designated as safety issue: Yes ]The results of routine examinations, which are necessary for all transplant patients, will be used once a year and analyzed retrospectively.
|Study Start Date:||April 2013|
|Estimated Study Completion Date:||March 2016|
|Estimated Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
Drug: MultiStem, Dose 1 of MultiStem; Route and time: Two infusions; First: intra portal at liver transplantation (day 1), second: intra venous (day 3)
Drug: MultiStem, Dose 2 of MultiStem; Route and time: Two infusions; First: intra portal at liver transplantation (day 1), second: intra venous (day 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)
Drug: MultiStem, Dose 4 of MultiStem; Route and time: Two infusions; First: intra portal at liver transplantation (day 1), second: intra venous (day 3)
|Contact: Marc H Dahlke, Prof. Dr.||0049 941 944 0||Marc.Dahlke@ukr.de|
|Department of Surgery, University Hospital Regensburg||Recruiting|
|Regensburg, Bavaria, Germany, 93053|
|Contact: Marc H Dahlke, Prof. Dr. 00499419440 Marc.Dahlke@ukr.de|
|Principal Investigator: Marc H Dahlke, Prof. Dr.|