Hepatocyte Matrix Implant Study Indonesia

Liver Cirrhosis Clinical Trial

— HMIIndo  

Official title:

Intracorporeal Autologous Hepatocyte Matrix Implant: A New Tissue Engineering Procedure for Treatment of Hepatic Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01335568
• Other study ID #: Baermed 002
• Status: Recruiting
• Phase: Phase 1
• First received: April 11, 2011
• Last updated: April 13, 2011
• Start date: April 2011
• Est. completion date: December 2012

Study information

• Verified date: April 2011
• Source: Baermed
• Contact: Suryadi The, Dr, MD
• Phone: +62 8129204193
• Email: sury4d1md[@]gmail.com
• Is FDA regulated: No
• Health authority: Indonesia: Kementerian Negara Riset Dan Teknologi, Sekretariat Perizinan Peneliti Asing (RISTEK)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Liver Disease
• Hepatic Insufficiency
• Liver Cirrhosis
• Liver Diseases
• Liver Insufficiency

Intervention

Procedure:
• Hepatocyte Matrix Implant
Open surgical procedure with biopsy of liver tissue and pancreatic tissue for proceeding in institutional GMP laboratory. Implantation of autologous hepatocytes and islet cells on scaffolds into the small bowel mesentery. Usually 10 to 20 implants are used.

Locations

Country	Name	City	State
Indonesia	R.S. Gading Pluit	Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Baermed

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of clinical and laboratory parameters of liver function	Evaluation of clinical parameters MELD, CHILD, Asictes, portal hypertension in comparison of values measured 3 and 6 months before operation Evaluation of laboratory parameters Bilirubin, ASAT, ALAT, alkaline phosphatase, cholinesterase, albumin, total protein	6 months	Yes

External Links

•   Baermed Centre for Abdominal Surgery, Zurich, Switzerland