Hepatocyte Matrix Implant Study Indonesia (HMIIndo)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Baermed.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Baermed
ClinicalTrials.gov Identifier:
NCT01335568
First received: April 11, 2011
Last updated: April 13, 2011
Last verified: April 2011
  Purpose

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.


Condition Intervention Phase
Liver Cirrhosis
Liver Insufficiency
Chronic Liver Disease
Procedure: Hepatocyte Matrix Implant
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intracorporeal Autologous Hepatocyte Matrix Implant: A New Tissue Engineering Procedure for Treatment of Hepatic Disease

Resource links provided by NLM:


Further study details as provided by Baermed:

Primary Outcome Measures:
  • Evaluation of clinical and laboratory parameters of liver function [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 10
Study Start Date: April 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: surgery
chronic liver insufficiency, cirrhosis
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.
Other Names:
  • Hepatocyte matrix implantation
  • Hepatocyte scaffold implantation
  • Cell matrix implant

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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01335568

Contacts
Contact: Suryadi The, Dr, MD +62 8129204193 sury4d1md@gmail.com
Contact: Hans U Baer, Prof MD +41 387 30 70 hans.baer@baermed.ch

Locations
Indonesia
R.S. Gading Pluit Recruiting
Jakarta, Indonesia, 14250
Sub-Investigator: Suryadi The, MD         
Sponsors and Collaborators
Baermed
Investigators
Principal Investigator: Hans U Baer, Prof, MD Baermed, RS Gading Pluit, UNTAR
  More Information

Additional Information:
No publications provided

Responsible Party: Hans U. Baer, RS Gading Pluit, Universitas Tarumanagara Indonesia and Baermed Switzerland
ClinicalTrials.gov Identifier: NCT01335568     History of Changes
Other Study ID Numbers: Baermed 002
Study First Received: April 11, 2011
Last Updated: April 13, 2011
Health Authority: Indonesia: Kementerian Negara Riset Dan Teknologi, Sekretariat Perizinan Peneliti Asing (RISTEK)

Keywords provided by Baermed:
Hepatocyte
Scaffold
Matrix
Liver cirrhosis
Liver insufficiency

Additional relevant MeSH terms:
Liver Cirrhosis
Fibrosis
Liver Diseases
Hepatic Insufficiency
Digestive System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 21, 2014