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Hepatocyte Matrix Implant Study (HMI)

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ClinicalTrials.gov Identifier: NCT00935454
Recruitment Status : Unknown
Verified July 2009 by Baermed.
Recruitment status was:  Recruiting
First Posted : July 9, 2009
Last Update Posted : April 12, 2011
Sponsor:
Information provided by:
Baermed

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.


Condition or disease Intervention/treatment Phase
Liver Disease Liver Cirrhosis Procedure: Hepatocyte matrix implantation Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intracorporeal Autologous Hepatocyte Matrix Implant: A New Tissue Engineering Procedure for Treatment of Hepatic Disease.
Study Start Date : July 2009
Estimated Primary Completion Date : September 2011
Estimated Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Diseases


Intervention Details:
  • Procedure: Hepatocyte matrix implantation

    First operation:

    Removal of liver tissue and biopsy of pancreas

    Second operation:

    Implantation of hepatocyte matrix implant into small bowel mesentery

    Other Names:
    • biocell liver
    • hepatocyte implant


Primary Outcome Measures :
  1. Liver function Postoperative complication [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00935454


Contacts
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Contact: Hans U. Baer, Prof +41 44 387 30 70 hans.baer@baermed.ch
Contact: Plamen Staikov, MD +41 44 387 30 70 plamen.staikov@baermed.ch

Locations
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Switzerland
Baermed Center For Abdominal Surgery Recruiting
Zürich, Switzerland, 8032
Contact: Janine Michel    +41 44 387 30 96    janine.michel@baermed.ch   
Sponsors and Collaborators
Baermed

Additional Information:
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Responsible Party: Hans U. Baer, MD, Professor in Universitas Tarumanagara, Baermed Center For Abdominal Surgery
ClinicalTrials.gov Identifier: NCT00935454     History of Changes
Other Study ID Numbers: Baermed-001
First Posted: July 9, 2009    Key Record Dates
Last Update Posted: April 12, 2011
Last Verified: July 2009

Keywords provided by Baermed:
hepatocyte matrix implantation
endstage liver disease
liver cirrhosis
impaired liver parenchyma
improvement of liver function

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