Liver DiseasePhase 1HMINCT00935454
Hepatocyte Matrix Implant Study
A Phase 1 study testing Hepatocyte matrix implantation in people with Liver Disease and Liver Cirrhosis, run by Baermed at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Disease, Liver Cirrhosis
- What is being tested?
- Hepatocyte matrix implantation
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2009to Mar 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Baermed Center For Abdominal Surgery
Zurich, Canton of Zurich, 8032
Janine Michel, +41 44 387 30 96, janine.michel@baermed.ch
About this study
Official title: Intracorporeal Autologous Hepatocyte Matrix Implant: A New Tissue Engineering Procedure for Treatment of Hepatic Disease.
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
- Being tested
- Hepatocyte matrix implantation
- Keywords
- hepatocyte matrix implantation, endstage liver disease, liver cirrhosis, impaired liver parenchyma, improvement of liver function
- Medical subject headings
- Liver Diseases, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hepatocyte matrix implantationProcedure or surgery
Also called biocell liver, hepatocyte implant
First operation:
Removal of liver tissue and biopsy of pancreas
Second operation:
Implantation of hepatocyte matrix implant into small bowel mesentery
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver function Postoperative complication
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionSep 2011 (estimated)
- Study completionMar 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baermed
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00935454
- Sponsor's protocol ID
- Baermed-001
- Acronym
- HMI
- Status last verified
- Jul 2009
- First submitted
- 8 Jul 2009
- Last updated
- 12 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracorporeal Autologous Hepatocyte Matrix Implant: A New Tissue Engineering Procedure for Treatment of Hepatic Disease.
- ClinicalTrials.gov ID
- NCT00935454
- Acronym / sponsor ID
- HMI / Baermed-001
- Conditions
- Liver Disease, Liver Cirrhosis
- Keywords
- hepatocyte matrix implantation, endstage liver disease, liver cirrhosis, impaired liver parenchyma, improvement of liver function
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- BaermedUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Sep 2011 (estimated)
- Study completion
- Mar 2012 (estimated)
- First posted
- 9 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hepatocyte matrix implantationAlso: biocell liver, hepatocyte implantFirst operation: Removal of liver tissue and biopsy of pancreas Second operation: Implantation of hepatocyte matrix implant into small bowel mesentery | Procedure or surgery | – |
Primary outcome
Liver function Postoperative complication
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2011.
- Center For Abdominal Surgery, Hirslanden HospitalLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Hepatocyte matrix implantation in people with Liver Disease and Liver Cirrhosis, run by Baermed at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hans U. Baer, Prof (+41 44 387 30 70, hans.baer@baermed.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver function Postoperative complication (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2011; AzTrials last refreshed its copy on 2 Nov 2026.