Clinical trial NCT01335568: Hepatocyte Matrix Implant Study Indonesia
Official title: Intracorporeal Autologous Hepatocyte Matrix Implant: A New Tissue Engineering Procedure for Treatment of Hepatic Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Liver Cirrhosis
Liver Insufficiency
Chronic Liver Disease
Keywords: Hepatocyte
Scaffold
Matrix
Liver cirrhosis
Liver insufficiency
Lead sponsor: Baermed
Sponsor class: OTHER
First posted: 2011-04-14
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* endstage liver disease
* stable and non-improving liver condition for at least 3 month
* alcoholic liver cirrhosis: proven alcohol abstinence for 6 month or more
* patient in bad general condition

Exclusion Criteria:

* pregnancy
* drug addiction (except alcohol)
* psychiatric disease
* HIV positive
* sepsis
* peritoneal carcinosis
* hereditary liver disease
* acute liver failure

Primary outcomes:
measure: Evaluation of clinical and laboratory parameters of liver function
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: R.S. Gading Pluit
Study officials:
affiliation: Baermed, RS Gading Pluit, UNTAR
name: Hans U Baer, Prof, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hendrawan S, Lheman J, Nuraeni, Weber U, Baer HU. Hepatocyte and Islet Cell Cotransplantation on Poly-L-Lactide Matrix for the Treatment of Liver Cirrhosis. Int J Hepatol. 2020 Oct 13;2020:5410359. doi: 10.1155/2020/5410359. eCollection 2020.