Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2026-02-25 @ 9:54 PM
Study NCT ID:
NCT01877759
Status:
UNKNOWN
Last Update Posted:
2013-10-09
First Post:
2013-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Study to Evaluate the Safety and Efficacy of Mesenchymal Stem Cells in 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', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-10-08', 'studyFirstSubmitDate': '2013-06-12', 'studyFirstSubmitQcDate': '2013-06-13', 'lastUpdatePostDateStruct': {'date': '2013-10-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Changes of any clinical symptoms like abdominal distension, appetite, debilitation', 'timeFrame': '6 month'}], 'primaryOutcomes': [{'measure': 'Improvement in Liver function tests', 'timeFrame': '6 month', 'description': '1\\) Improvement of Liver Function tests liver functions( Albumin (ALB), Alanine aminotransferase (ALT), Aspartate Aminotransferase (AST), Prealbumin(PA), total bilirubin (TB), and direct bilirubin (DB) kidney function Blood urea nitrogen (BUN), Urea (UA), and Crea (Cr)),international normalized ratio (INR) in Liver Cirrhosis Patients'}], 'secondaryOutcomes': [{'measure': 'Changes in liver function according to Child-Pugh', 'timeFrame': '6 MONTH'}, {'measure': 'Changes in liver function according to MELD Score', 'timeFrame': '6 MONTH'}, {'measure': 'Improvement in QUALITY OF LIFE SCALE (QOL)', 'timeFrame': '6 month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Stem cell ,liver cirrhosis'], 'conditions': ['Liver Cirrhosis']}, 'descriptionModule': {'briefSummary': "Cirrhosis is caused by sustained liver damage over several years either by alcohol, viral infection (Hepatitis B, C), a toxic substance (for eg. drugs, excess copper or iron in the liver), or by blockage of biliary system such that the liver undergoes progressive scarring that slowly replaces all of normal liver cells.(LC) represents a late stage of progressive hepatic fibrosis characterized by distortion of the hepatic architecture and formation of regenerative nodules. For this condition of disease the liver transplantation is one of the only effective therapies available ,but due to lack of donors, surgical complications, rejection, and high cost are it's serious problems.\n\nPresently stem cells are used to be a one of the treatment for the same. So our approach is to evaluate the safety and efficacy of mesenchymal stem cell in condition of liver cirrhosis .", 'detailedDescription': 'In this study, the patients with liver cirrhosis will undergo administration of human Mesenchymal stem cell MSCs intravenously for these patients.To observe the results Liver function will be monitored by serum analysis.The levels of serum alanine aminotransferase (ALT), total bilirubin (TB), prothrombin time (PT), prealbumin(PA) and albumin (ALB) will be examined at pre-transfusion, and 6th days to 1 years post-transfusion.Also the to see Improvement evaluation by MELD score ,Quality of life ,Child-Pugh score will be done .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria\n\n* 25 -65 Ages Eligible for Study\n* Clinical diagnosis of liver cirrhosis\n* Ability to comprehend the explained protocol and thereafter give an informed consent as well as sign the required Informed Consent Form (ICF) for the study.\n* Expecting lifetime is over three years\n* Ready to come all visits\n\nExclusion Criteria:\n\n* History of life threatening allergic or immune-mediated reaction\n* Positive test results for HIV and AIDS complex ,HCV , HbsAg and Syphilis\n* Malignancies\n* Sepsis\n* Vital organs failure\n* Pregnant or lactating women\n* Subject who has been transplanted recently\n* If the investigator or treating physician feels that the Subject with any disease or condition would interfere with the trial or the safety of patient'}, 'identificationModule': {'nctId': 'NCT01877759', 'briefTitle': 'A Clinical Study to Evaluate the Safety and Efficacy of Mesenchymal Stem Cells in Liver Cirrhosis', 'organization': {'class': 'OTHER', 'fullName': 'Chaitanya Hospital, Pune'}, 'officialTitle': 'Role of Bone Marrow Derived Autologous Stem Cells + Human Umbilical Cord Derived Mesenchymal Stem Cells for the Treatment of Liver Cirrhosis', 'orgStudyIdInfo': {'id': 'CSCC/BM/2013/LS/01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Mesenchymal stem cell', 'description': 'hUMAN MESENCHYMAL STEM CELLS', 'interventionNames': ['Biological: Mesenchymal stem cell']}], 'interventions': [{'name': 'Mesenchymal stem cell', 'type': 'BIOLOGICAL', 'description': 'Intravenous dose of Mesenchymal stem cell derived from human Bone Marrow \\& umbilical cord , IN 6 divided doses , at interval of 1 week .', 'armGroupLabels': ['Mesenchymal stem cell']}]}, 'contactsLocationsModule': {'locations': [{'zip': '411009', 'city': 'Pune', 'state': 'Maharashtra', 'country': 'India', 'contacts': [{'name': 'Sachin P Jamadar, D ORTHO', 'role': 'CONTACT', 'email': 'sac2751982@gmail.com', 'phone': '+918888788880'}, {'name': 'Smita S Bhoyar, BAMS.PGCR', 'role': 'CONTACT', 'email': 'drsmitabhoyar@rediffmail.com', 'phone': '9372620569'}, {'name': 'Anant E Bagul, MS,Ortho', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chaitanya Hospital', 'geoPoint': {'lat': 18.51957, 'lon': 73.85535}}], 'centralContacts': [{'name': 'Sachin P Jamadar, D.Ortho', 'role': 'CONTACT', 'email': 'sac2751982@gmail.com', 'phone': '918888788880'}, {'name': 'Smita S Bhoyar, B.A.M.S.PGCR', 'role': 'CONTACT', 'email': 'drsmitabhoyar@rediff.com', 'phone': '9372620569'}], 'overallOfficials': [{'name': 'ANANT E BAGUL, MS ORTHO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chaitanya Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chaitanya Hospital, Pune', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Co -investigator', 'investigatorFullName': 'Dr. Sachin Jamadar', 'investigatorAffiliation': 'Chaitanya Hospital, Pune'}}}}