NCT01841632

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

Safety and Feasibility of Multipotent Adult Progenitor Cells for Immunomodulation Therapy After Liver Transplantation: A Phase I Study of the MiSOT Study Consortium

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Prof. Dr. Marc-H. Dahlke, Ph. D. · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Liver Transplantation

Interventions

Type	Name	Description
DRUG	MultiStem

Timeline

• Start date: 2013-04-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2013-04-26
• Last updated: 2018-08-17
• Results posted: 2018-08-17

Locations

1 site across 1 country: Germany