HMI: Hepatocyte Matrix Implant Study

• Sponsor: Baermed (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00935454
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Duration (Months): 32
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• Anticipated 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: Jul 1, 2009
• Anticipated Primary Completion Date: Sep 1, 2011
• Anticipated Study Completion Date: Mar 1, 2012

Outcome Measures

Primary Outcome Measures

1. Liver function Postoperative complication [2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Baermed Center For Abdominal Surgery	Zürich		Switzerland	8032

Sponsors and Collaborators

• Baermed

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Center For Abdominal Surgery, Hirslanden Hospital

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00935454
• Other Study ID Numbers: Baermed-001
• First Posted: Jul 9, 2009
• Last Update Posted: Apr 12, 2011
• Last Verified: Jul 1, 2009

• Keywords provided by , ,: hepatocyte matrix implantation; endstage liver disease; liver cirrhosis; impaired liver parenchyma; improvement of liver function
• Additional relevant MeSH terms: Liver Cirrhosis; Liver Diseases; Fibrosis

Study Results

No Results Posted as of Apr 12, 2011