Hepatocyte Matrix Implant Study Indonesia

NCT01335568 | Unknown Phase 1 DMC

• 1 other identifier: Baermed 002
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cirrhosis; Liver Insufficiency; Chronic Liver Disease

Keywords

Hepatocyte; Scaffold; Matrix; Liver cirrhosis; Liver insufficiency

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

surgery

EXPERIMENTAL

chronic liver insufficiency, cirrhosis

Procedure: Hepatocyte Matrix Implant

Interventions

Hepatocyte Matrix Implant PROCEDURE

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.

Also known as: Hepatocyte matrix implantation, Hepatocyte scaffold implantation, Cell matrix implant

surgery

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Baermed: lead

Study Sites (1)

R.S. Gading Pluit

Jakarta, 14250, Indonesia

RECRUITING

Related Publications (1)

• 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.

  PMID: 33123384 DERIVED

Related Links

• Baermed Centre for Abdominal Surgery, Zurich, Switzerland

MeSH Terms

Conditions

Liver Cirrhosis; Hepatic Insufficiency

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hans U Baer, Prof, MD

  Baermed, RS Gading Pluit, UNTAR

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Suryadi The, Dr, MD

CONTACT

+62 8129204193; sury4d1md@gmail.com

Hans U Baer, Prof MD

CONTACT

+41 387 30 70; hans.baer@baermed.ch

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 11, 2011
• First Posted: April 14, 2011
• Study Start: April 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2012
• Last Updated: April 14, 2011

Record last verified: 2011-04

Locations

ID (1)