Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2026-01-14 @ 2:27 PM
Study NCT ID:
NCT02585505
Status:
COMPLETED
Last Update Posted:
2015-10-23
First Post:
2015-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tissue Distribution of F18-FDG Labeled ABMSCT in Patients With Type2 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-22', 'studyFirstSubmitDate': '2015-10-19', 'studyFirstSubmitQcDate': '2015-10-22', 'lastUpdatePostDateStruct': {'date': '2015-10-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Increase in glucagon stimulated C peptide level', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Non-Insulin-Dependent']}, 'descriptionModule': {'briefSummary': 'Stem cells have promising potential in treating diabetes. However the therapeutic outcome in diabetic patients will profoundly depend on their delivery to pancreas. Our objective is to label stem cells with PET tracer F18-FDG to carry out in vivo cell tracking. The labeled stem cells will be given through different routes (intravenous and intraarterial)and tissue distribution studied. Patients will be followed up for the next 6 months. Glucagon stimulated C peptide will be measured at baseline and at 6 months and HOMA IR and HOMA beta will be calculated.', 'detailedDescription': 'Our objective is to label stem cells with PET tracer F18-FDG to carry out in vivo cell tracking. The labeled stem cells will be given through different routes (intravenous and intraarterial)and tissue distribution studied. Patients will be followed up for the next 6 months. Glucagon stimulated C peptide will be measured at baseline and at 6 months and HOMA IR and HOMA beta will be calculated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Patients with type 2 diabetes mellitus between 30 and 65 years of age.\n\n * Duration of diabetes ≥ 5 years.\n * Failure to triple OHA in optimal doses {glimepiride (4 gm), metformin(2-2.5 gm) and pioglitazone(15mg)}.\n * Requiring insulin therapy for last six month\n * On stable doses of insulin (≥0.4 IU/kg/day, Vildagliptin, metformin (2 gm), pioglitazone (15mg) for last three months.\n * GAD antibody negative status.\n\nExclusion Criteria:\n\n* Patients with type 1 diabetes mellitus or secondary diabetes\n* Patients with serum creatinine \\> 1.5 mg/dL\n* Abnormal liver function tests (defined as value of transaminases \\> 3 times the upper value of normal or serum bilirubin higher than normal for the reference value for the laboratory).\n* History of cholecystitis/ cholelithiasis/ cholecystectomy.\n* Seropositivity for HIV, HBsAg and HCV.\n* History of myocardial infarction or unstable angina or any cardiovascular events in the previous 3 months.'}, 'identificationModule': {'nctId': 'NCT02585505', 'briefTitle': 'Tissue Distribution of F18-FDG Labeled ABMSCT in Patients With Type2 Diabetes Mellitus', 'organization': {'class': 'UNKNOWN', 'fullName': 'PIMERIndia'}, 'officialTitle': 'Tissue Distribution of F18-FDG Labeled Autologous Bone Marrow Derived Stem Cells in Patients With Type2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'PGI NUC MED'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intravenous', 'description': 'stem cells will be injected through intravenously in the subjects', 'interventionNames': ['Procedure: stem cells']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'superior pancreaticoduodenal', 'description': 'stem cells', 'interventionNames': ['Procedure: stem cells']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'splenic artery', 'description': 'stem cells will be injected through splenic in the subjects', 'interventionNames': ['Procedure: stem cells']}], 'interventions': [{'name': 'stem cells', 'type': 'PROCEDURE', 'description': 'stem cell will be injected', 'armGroupLabels': ['Intravenous', 'splenic artery', 'superior pancreaticoduodenal']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Post Graduate Institute of Medical Education and Research, Chandigarh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head, Dept of Endocrinology', 'investigatorFullName': 'Anil Bhansali', 'investigatorAffiliation': 'Post Graduate Institute of Medical Education and Research, Chandigarh'}}}}