Liver Cirrhosis Clinical Trial
Official title:
Intracorporeal Autologous Hepatocyte Matrix Implant: A New Tissue Engineering Procedure for Treatment of Hepatic Disease
This clinical investigation of the hepatocyte matrix implant is an evaluation blinded
non-randomized and monocentric pilot study of Phase I, which is conducted as a therapeutic
investigation. Randomization is not possible due to ethical and practical reasons. This
study has already been approved in Switzerland and has been adapted to Indonesian Law and
disease.
This new treatment procedure has already been successfully used on the basis of
compassionate use in Germany. The hepatocyte matrix implant is a new patented procedure
consisting of bio-matrix technology. A formaldehyde-free special matrix consisting of
self-dissolving polymers is applied as a carrier substance and is cultivated with human
autologous cells using a special technique. Clinically the bio artificial liver replacement
tissue for patients with end-stage hepatic disease has been developed as a first
application. In this procedure autologous hepatocytic tissue and pancreatic tissue is
removed (liver resection and pancreatic biopsy) from the patient in a first surgical
procedure. The tissue is sent to a specialized Cell Culture Laboratory. The laboratory is
GMP certified for this procedure. The cells are processed according to SOPs in a special
perfusion procedure and prepared on several platelets of matrices (platelets of 20 mm
diameter and 4mm thickness). After completion of the laboratory process the bio tissues are
implanted into the mesentery of the small intestine during a second operation. The cells are
growing controlled on the matrix, take on the capillaries of the patient and thus connect to
the blood circulation. The implanted cells multiply by a specific factor and independently
take over the metabolic function of the original liver after two to four weeks. In the
following process the carrier matrix dissolves completely and implanted cells develop into
liver cell tissue.
This new treatment procedure has already been successfully used on the basis of individual treatment in Germany. The hepatocyte matrix implant is a new patented procedure consisting of bio-matrix technology. A formaldehyde-free special matrix consisting of self-dissolving polymers is applied as a carrier substance and is cultivated with human autologous cells using a special technique. Clinically the bio artificial liver replacement tissue for patients with end-stage hepatic disease has been developed as a first application. In this procedure autologous hepatocytic tissue and pancreatic tissue is removed (liver resection and pancreatic biopsy) from the patient in a first surgical procedure. The tissue is sent to a specialized Cell Culture Laboratory. The laboratory is GMP certified for this procedure. The cells are processed according to SOPs in a special perfusion procedure and prepared on several platelets of matrices (platelets of 20 mm diameter and 4mm thickness). After completion of the laboratory process the bio tissues are implanted into the mesentery of the small intestine during a second operation. The cells are growing controlled on the matrix, take on the capillaries of the patient and thus connect to the blood circulation. The implanted cells multiply by a specific factor and independently take over the metabolic function of the original liver after two to four weeks. In the following process the carrier matrix dissolves completely and implanted cells develop into liver cell tissue. ;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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