Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2026-01-10 @ 5:41 PM
Study NCT ID:
NCT01143168
Status:
UNKNOWN
Last Update Posted:
2010-06-14
First Post:
2010-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stem Cell Therapy for Type 1 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-06', 'completionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-06-11', 'studyFirstSubmitDate': '2010-06-10', 'studyFirstSubmitQcDate': '2010-06-11', 'lastUpdatePostDateStruct': {'date': '2010-06-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of reducing exogenous insulin requirement; Hemoglobin A1c; Fast blood glucose (FBG) and postmeal blood glucose (PBG); C-peptide levels.', 'timeFrame': '1 year', 'description': 'Rate of reducing exogenous insulin requirement compared with baseline. Hemoglobin A1c. Fast blood glucose (FBG) and postmeal blood glucose (PBG). C-peptide levels.'}], 'secondaryOutcomes': [{'measure': 'Serious adverse event frequency and severity', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['stem cells;', 'diabetes mellitus;', 'treatment.'], 'conditions': ['Type 1 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the feasibility, efficacy and safety of transplantation therapy using bone marrow mononuclear cells and umbilical cord mesenchymal stem cells for patients with type 1 diabetes mellitus', 'detailedDescription': 'To evaluate the feasibility, safety and efficacy of transplantation using autologous bone marrow mononuclear cells and umbilical cord mesenchymal stem cells in patients with type 1 diabetes mellitus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Free will taking part in the study and ability to provide written informed consent.\n2. Confirmed diagnosis of type I diabetes for at least 2 years\n3. Insulin-dependent.\n4. Age 18-50 years, Male/Female.\n5. FBG≥7.0 mmol/L, and HbAc1≥7％.\n6. Not pregnant or nursing.\n7. Negative pregnancy test.\n8. Fertile patients will use effective contraception.\n\nExclusion Criteria:\n\n1. Presence of acute diabetic complications in the acute stage as recent myocardial infarction, recent cerebral vascular accident (CVA) or acute renal failure.\n2. Severe concurrent medical condition (e.g. lung disease, or hematopoietic dysfunction, or liver dysfunction).\n3. Active infection requiring treatment.\n4. Known immunosuppressive disease, e.g. HIV infection, or hepatitis B or C infection.'}, 'identificationModule': {'nctId': 'NCT01143168', 'briefTitle': 'Stem Cell Therapy for Type 1 Diabetes Mellitus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cellonis Biotechnology Co. Ltd.'}, 'officialTitle': 'A Pilot Study on Transplantation Therapy Using Autologous Bone Marrow Mononuclear Cells and Umbilical Cord Mesenchymal Stem Cells in Patients With Type 1 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'Cellonis-CR-1.3'}}, 'armsInterventionsModule': {'interventions': [{'name': 'autologous bone marrow mononuclear cells and umbilical cord mesenchymal stem cells', 'type': 'BIOLOGICAL', 'description': 'First Transplantation: after finishing all required examines according to protocol on Day 0, ABM-MNCs + UCMSCs are transplanted through pancreas artery percutaneously; Second Transplantation: after finishing all required examines on Day 7±1, BM-MNCs UCMSCs are transplanted intravenously; Third Transplantation: after finishing all required examines on Day 14±2, BM-MNCs + UCMSCs are transplanted intravenously.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100085', 'city': 'Beijing', 'country': 'China', 'facility': 'Armed Police General Hospital, P. R. China', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Shi X Y, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Armed Police General Hospital, P. R. China'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cellonis Biotechnology Co. Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Cellonis Biotechnology Co. Ltd.', 'oldOrganization': 'Others'}}}}