Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2025-12-29 @ 11:05 AM
Study NCT ID:
NCT01335568
Status:
UNKNOWN
Last Update Posted:
2011-04-14
First Post:
2011-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hepatocyte Matrix Implant Study Indonesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D048550', 'term': 'Hepatic Insufficiency'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'completionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-04-13', 'studyFirstSubmitDate': '2011-04-11', 'studyFirstSubmitQcDate': '2011-04-13', 'lastUpdatePostDateStruct': {'date': '2011-04-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of clinical and laboratory parameters of liver function', 'timeFrame': '6 months', 'description': 'Evaluation of clinical parameters MELD, CHILD, Asictes, portal hypertension in comparison of values measured 3 and 6 months before operation Evaluation of laboratory parameters Bilirubin, ASAT, ALAT, alkaline phosphatase, cholinesterase, albumin, total protein'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hepatocyte', 'Scaffold', 'Matrix', 'Liver cirrhosis', 'Liver insufficiency'], 'conditions': ['Liver Cirrhosis', 'Liver Insufficiency', 'Chronic Liver Disease']}, 'referencesModule': {'references': [{'pmid': '33123384', 'type': 'DERIVED', 'citation': 'Hendrawan S, Lheman J, Nuraeni, Weber U, Baer HU. Hepatocyte and Islet Cell Cotransplantation on Poly-L-Lactide Matrix for the Treatment of Liver Cirrhosis. Int J Hepatol. 2020 Oct 13;2020:5410359. doi: 10.1155/2020/5410359. eCollection 2020.'}], 'seeAlsoLinks': [{'url': 'http://baermed.ch', 'label': 'Baermed Centre for Abdominal Surgery, Zurich, Switzerland'}]}, 'descriptionModule': {'briefSummary': '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. This study has already been approved in Switzerland and has been adapted to Indonesian Law and disease.\n\nThis 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 bio artificial 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 bio tissues 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.', 'detailedDescription': 'This new treatment procedure has already been successfully used on the basis of individual treatment 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 bio artificial 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 bio tissues 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* endstage liver disease\n* stable and non-improving liver condition for at least 3 month\n* alcoholic liver cirrhosis: proven alcohol abstinence for 6 month or more\n* patient in bad general condition\n\nExclusion Criteria:\n\n* pregnancy\n* drug addiction (except alcohol)\n* psychiatric disease\n* HIV positive\n* sepsis\n* peritoneal carcinosis\n* hereditary liver disease\n* acute liver failure'}, 'identificationModule': {'nctId': 'NCT01335568', 'acronym': 'HMIIndo', 'briefTitle': 'Hepatocyte Matrix Implant Study Indonesia', 'organization': {'class': 'OTHER', 'fullName': 'Baermed'}, 'officialTitle': 'Intracorporeal Autologous Hepatocyte Matrix Implant: A New Tissue Engineering Procedure for Treatment of Hepatic Disease', 'orgStudyIdInfo': {'id': 'Baermed 002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'surgery', 'description': 'chronic liver insufficiency, cirrhosis', 'interventionNames': ['Procedure: Hepatocyte Matrix Implant']}], 'interventions': [{'name': 'Hepatocyte Matrix Implant', 'type': 'PROCEDURE', 'otherNames': ['Hepatocyte matrix implantation', 'Hepatocyte scaffold implantation', 'Cell matrix implant'], 'description': 'Open surgical procedure with biopsy of liver tissue and pancreatic tissue for proceeding in institutional GMP laboratory. Implantation of autologous hepatocytes and islet cells on scaffolds into the small bowel mesentery. Usually 10 to 20 implants are used.', 'armGroupLabels': ['surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14250', 'city': 'Jakarta', 'status': 'RECRUITING', 'country': 'Indonesia', 'contacts': [{'name': 'Suryadi The, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'R.S. Gading Pluit', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}], 'centralContacts': [{'name': 'Suryadi The, Dr, MD', 'role': 'CONTACT', 'email': 'sury4d1md@gmail.com', 'phone': '+62 8129204193'}, {'name': 'Hans U Baer, Prof MD', 'role': 'CONTACT', 'email': 'hans.baer@baermed.ch', 'phone': '+41 387 30 70'}], 'overallOfficials': [{'name': 'Hans U Baer, Prof, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baermed, RS Gading Pluit, UNTAR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baermed', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Hans U. Baer', 'oldOrganization': 'RS Gading Pluit, Universitas Tarumanagara Indonesia and Baermed Switzerland'}}}}