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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
- Procedure: Hepatocyte matrix implantation
Removal of liver tissue and biopsy of pancreas
Implantation of hepatocyte matrix implant into small bowel mesenteryOther Names:
- biocell liver
- hepatocyte implant
- Liver function Postoperative complication [ Time Frame: 2 years ]
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
|Contact: Hans U. Baer, Prof||+41 44 387 30 email@example.com|
|Contact: Plamen Staikov, MD||+41 44 387 30 firstname.lastname@example.org|
|Baermed Center For Abdominal Surgery||Recruiting|
|Zürich, Switzerland, 8032|
|Contact: Janine Michel +41 44 387 30 96 email@example.com|