Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
10 participants
INTERVENTIONAL
2009-07-31
2012-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* drug addiction (except alcohol)
* psychiatric disease
* HIV positive
* sepsis
* peritoneal carcinosis
* hereditary liver disease
* acute liver failure
18 Years
ALL
No
Sponsors
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Baermed
OTHER
Responsible Party
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Baermed Center For Abdominal Surgery
Locations
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Baermed Center For Abdominal Surgery
Zurich, Canton of Zurich, Switzerland
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Center For Abdominal Surgery, Hirslanden Hospital
Other Identifiers
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Baermed-001
Identifier Type: -
Identifier Source: org_study_id
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