Hepatocyte Matrix Implant Study

NCT00935454 | Unknown Phase 1 DMC

• 1 other identifier: Baermed-001
• 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. Pending approval of the ethical committee the study will also be conducted in Indonesia. 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 bioartificial 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 biotissues 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 Disease; Liver Cirrhosis

Keywords

hepatocyte matrix implantation; endstage liver disease; liver cirrhosis; impaired liver parenchyma; improvement of liver function

Outcome Measures

Primary Outcomes (1)

• Liver function Postoperative complication

  2 years

Interventions

Hepatocyte matrix implantation PROCEDURE

First operation: Removal of liver tissue and biopsy of pancreas Second operation: Implantation of hepatocyte matrix implant into small bowel mesentery

Also known as: biocell liver, hepatocyte implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• 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)

Baermed Center For Abdominal Surgery

Zurich, Canton of Zurich, 8032, Switzerland

RECRUITING

Related Links

• Center For Abdominal Surgery, Hirslanden Hospital

MeSH Terms

Conditions

Liver Diseases; Liver Cirrhosis

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Hans U. Baer, Prof

CONTACT

+41 44 387 30 70; hans.baer@baermed.ch

Plamen Staikov, MD

CONTACT

+41 44 387 30 70; plamen.staikov@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: July 8, 2009
• First Posted: July 9, 2009
• Study Start: July 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: March 1, 2012
• Last Updated: April 12, 2011

Record last verified: 2009-07

Locations

CH (1)