Ignite Creation Date:
2025-12-25 @ 12:52 AM
Ignite Modification Date:
2026-04-16 @ 4:59 AM
Study NCT ID:
NCT02297867
Status:
COMPLETED
Last Update Posted:
2018-04-17
First Post:
2014-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial Study About Human Adipose-Derived Stem Cells in the Liver Cirrhosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008103', 'term': 'Liver Cirrhosis'}], '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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2018-03-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-15', 'studyFirstSubmitDate': '2014-11-19', 'studyFirstSubmitQcDate': '2014-11-20', 'lastUpdatePostDateStruct': {'date': '2018-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MELD', 'timeFrame': '1-6 month', 'description': "MELD uses the patient's values for serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time (INR) to predict survival. It is calculated according to the following formula:MELD = 3.78\\[Ln serum bilirubin (mg/dL)\\] + 11.2\\[Ln INR\\] + 9.57\\[Ln serum creatinine (mg/dL)\\] + 6.43."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Liver Cirrhosis']}, 'referencesModule': {'references': [{'pmid': '22776464', 'type': 'BACKGROUND', 'citation': 'Harn HJ, Lin SZ, Hung SH, Subeq YM, Li YS, Syu WS, Ding DC, Lee RP, Hsieh DK, Lin PC, Chiou TW. Adipose-derived stem cells can abrogate chemical-induced liver fibrosis and facilitate recovery of liver function. Cell Transplant. 2012;21(12):2753-64. doi: 10.3727/096368912X652959. Epub 2012 Jul 5.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the investigators study was to investigate the safety and efficacy of autologous ADSCs for the clinical treatment of liver cirrhosis.', 'detailedDescription': 'One milliliter of cell suspension will be injected intrahepatically under sonographic guidance using a gauge-18 needle.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Liver cirrhosis investigators with age 20 to 80 years (both inclusive).\n2. Investigators without Mandatory Communicable Disease (HBV, HCV, HIV, syphilis)\n3. Investigators without rare disorder\n4. Coagulation normalities\n5. Investigators without autoimmune disorder\n6. Investigators without Acquired Immune Deficiency Syndrome\n7. Investigators without cancer\n8. Investigators BMI \\> 15\n\nExclusion Criteria:\n\n1. Pregnant women\n2. Investigators with acute stroke in one month and unconsciousness\n3. Investigators with acute myocardial infarction or acute heart failure\n4. Investigators with serious liver dysfunction and coagulation dysfunction and ascites mild higher\n5. Investigators with acute respiratory failure or pneumonia\n6. Kidney Failure: BUN \\> 50\n7. Anemia: Hematocrit \\< 25\n8. Investigators diagnosed with liver cancer or liver metastatic carcinoma\n9. Investigators with liver abscess\n10. Investigators with acute Hepatitis\n11. Investigators with acute infective\n12. Liver cirrhosis patients with HBV or HCV\n13. Investigators diagnosed with carcinoma and receiving treatment\n14. Investigators with Schizophrenia or melancholia\n15. Investigators received serious surgical operations in 3 months\n16. Investigators unable to control hypertension (SBP \\> 180 mmHg, DBP \\> 110 mmHg) or diabetes (AC sugar \\> 200 mg/dl)\n17. Others can't fit into the trial evaluate by investigator"}, 'identificationModule': {'nctId': 'NCT02297867', 'briefTitle': 'Clinical Trial Study About Human Adipose-Derived Stem Cells in the Liver Cirrhosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gwo Xi Stem Cell Applied Technology Co., Ltd.'}, 'officialTitle': 'Adipose-Derived Stem Cells (ADSCs) Injections for Liver Cirrhosis', 'orgStudyIdInfo': {'id': '28113265'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ADSCs', 'description': 'One milliliter of cell suspension will be injected intrahepatically under sonographic guidance using a gauge-18 needle.', 'interventionNames': ['Drug: ADSCs']}], 'interventions': [{'name': 'ADSCs', 'type': 'DRUG', 'otherNames': ['hADSCs'], 'description': 'autologous ADSCs', 'armGroupLabels': ['ADSCs']}]}, 'contactsLocationsModule': {'locations': [{'zip': '65152', 'city': 'Taichung', 'state': 'Beigang', 'country': 'Taiwan', 'facility': 'China Medical University Beigang Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'zip': '30261', 'city': 'Hsinchu', 'country': 'Taiwan', 'facility': 'Gwo Xi Stem Cell Applied Technology Co., Ltd.', 'geoPoint': {'lat': 24.80361, 'lon': 120.96861}}], 'overallOfficials': [{'name': 'CMU B Hospital', 'role': 'STUDY_DIRECTOR', 'affiliation': 'China Medical University Beigang Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'CRO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gwo Xi Stem Cell Applied Technology Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'China Medical University Beigang Hospital', 'investigatorFullName': 'Sabrina Huang', 'investigatorAffiliation': 'Gwo Xi Stem Cell Applied Technology Co., Ltd.'}}}}