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Hepatocyte Matrix Implant Study (HMI)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Baermed.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Baermed
ClinicalTrials.gov Identifier:
NCT00935454
First received: July 8, 2009
Last updated: April 11, 2011
Last verified: July 2009
  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. 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 Intervention Phase
Liver Disease
Liver Cirrhosis
Procedure: Hepatocyte matrix implantation
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:
  • Liver function Postoperative complication [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 10
Study Start Date: July 2009
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  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: NCT00935454

Contacts
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
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
  More Information

Additional Information:
No publications provided

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
Study First Received: July 8, 2009
Last Updated: April 11, 2011
Health Authority: Switzerland: Federal Office of Public Health
Switzerland: Ethikkommission
Switzerland: Swissmedic

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

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

ClinicalTrials.gov processed this record on July 24, 2014