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Hepatocyte Matrix Implant Study (HMI)

Primary Purpose

Liver Disease, Liver Cirrhosis

Status
Unknown status
Phase
Phase 1
Locations
Switzerland
Study Type
Interventional
Intervention
Hepatocyte matrix implantation
Sponsored by
Baermed
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Disease focused on measuring hepatocyte matrix implantation, endstage liver disease, liver cirrhosis, impaired liver parenchyma, improvement of liver function

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Main 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

Main Exclusion Criteria:

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

Sites / Locations

  • Baermed Center For Abdominal SurgeryRecruiting

Outcomes

Primary Outcome Measures

Liver function Postoperative complication

Secondary Outcome Measures

Full Information

First Posted
July 8, 2009
Last Updated
April 11, 2011
Sponsor
Baermed
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1. Study Identification

Unique Protocol Identification Number
NCT00935454
Brief Title
Hepatocyte Matrix Implant Study
Acronym
HMI
Official Title
Intracorporeal Autologous Hepatocyte Matrix Implant: A New Tissue Engineering Procedure for Treatment of Hepatic Disease.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Unknown status
Study Start Date
July 2009 (undefined)
Primary Completion Date
September 2011 (Anticipated)
Study Completion Date
March 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Baermed

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Disease, Liver Cirrhosis
Keywords
hepatocyte matrix implantation, endstage liver disease, liver cirrhosis, impaired liver parenchyma, improvement of liver function

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Hepatocyte matrix implantation
Other Intervention Name(s)
biocell liver, hepatocyte implant
Intervention Description
First operation: Removal of liver tissue and biopsy of pancreas Second operation: Implantation of hepatocyte matrix implant into small bowel mesentery
Primary Outcome Measure Information:
Title
Liver function Postoperative complication
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main 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 Main Exclusion Criteria: pregnancy drug addiction (except alcohol) psychiatric disease HIV positive sepsis peritoneal carcinosis hereditary liver disease acute liver failure
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hans U. Baer, Prof
Phone
+41 44 387 30 70
Email
hans.baer@baermed.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Plamen Staikov, MD
Phone
+41 44 387 30 70
Email
plamen.staikov@baermed.ch
Facility Information:
Facility Name
Baermed Center For Abdominal Surgery
City
Zürich
ZIP/Postal Code
8032
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janine Michel
Phone
+41 44 387 30 96
Email
janine.michel@baermed.ch

12. IPD Sharing Statement

Links:
URL
http://www.baermed.ch
Description
Center For Abdominal Surgery, Hirslanden Hospital

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Hepatocyte Matrix Implant Study

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