Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-30 @ 3:53 AM
Study NCT ID:
NCT01142050
Status:
UNKNOWN
Last Update Posted:
2010-06-11
First Post:
2010-06-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stem Cell Therapy for Type 2 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', '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': '2010-06-10', 'studyFirstSubmitDate': '2010-06-10', 'studyFirstSubmitQcDate': '2010-06-10', 'lastUpdatePostDateStruct': {'date': '2010-06-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ITT; insulin dosage; Hemoglobin A1c; Fast blood glucose (FBG) and Postmeal blood glucose (PBG); C-peptide levels; Serum Insulin levels;', 'timeFrame': 'one year', 'description': '1. Insulin resistance index indicated by ITT change compared with baseline.\n2. Rate of reducing exogenous insulin requirement and OGLD dosage compared with baseline.\n3. Hemoglobin A1c.\n4. Fast blood glucose (FBG) and Postmeal blood glucose (PBG).\n5. C-peptide levels.\n6. Serum Insulin levels.'}], 'secondaryOutcomes': [{'measure': 'Serious adverse event frequency and severity', 'timeFrame': 'one year'}]}, 'conditionsModule': {'keywords': ['stem cells;', 'diabetes mellitus;', 'treatment.'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the efficacy and safety in the treatment of Insulin Resistance of Type 2 Diabetes Mellitus with Bone Marrow Mesenchymal Stem Cells.', 'detailedDescription': '* To evaluate the feasibility and safety of transplantation treatment using umbilical cord mesenchymal stem cells in patients with type 2 diabetes mellitus undergoing insulin injection treatments.\n* To assess efficacy of transplantation treatment using umbilical cord mesenchymal stem cells in patients with type 2 diabetes mellitus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 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. Type 2 diabetes mellitus (as guideline WHO, 1999);\n3. Age 18-75 years old，Male/Female;\n4. 19≤Body mass index (BMI)≤30㎏/㎡;\n5. Fast blood glucose (FBG)≥7.0 mmol/L, and HbAc1≥7％;\n6. Intravenous insulin tolerance test（ITT）indicate patient being insulin resistance;\n7. Not pregnant or nursing;\n8. Negative pregnancy test;\n9. Fertile patients will use effective contraception.\n\nExclusion Criteria:\n\n1. Severe concurrent medical condition (e.g., serious heart disease, lung disease, or hematopoietic dysfunction, or liver dysfunction, or kidney dysfunction);\n2. Active infection requiring treatment;\n3. Unexplained febrile illness;\n4. Known immunosuppressive disease, e.g. HIV infection, or hepatitis B or C infection.'}, 'identificationModule': {'nctId': 'NCT01142050', 'briefTitle': 'Stem Cell Therapy for Type 2 Diabetes Mellitus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cellonis Biotechnology Co. Ltd.'}, 'officialTitle': 'A Open Labeled and Self Controlled, Safety/Efficacy Assessed Pilot Study on Transplantation Therapy Using Bone Marrow Mesenchymal Stem Cells for Insulin Resistance of Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'Cellonis-CR-2.3'}}, 'armsInterventionsModule': {'interventions': [{'name': 'mesenchymal stem cells', 'type': 'BIOLOGICAL', 'description': '1.1st transplantation: after finishing all required examines according to protocol in Day 0, ABM-MSCs are transplanted through pancreas artery percutaneously; 2. 2nd transplantation: after finishing all required examines in Day 7±1, BM-MSCs are transplanted intravenously; 3. 3rd transplantation: after finishing all required examines in Day 14±2, BM-MSCs are transplanted intravenously.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100085', 'city': 'Beijing', 'country': 'China', 'contacts': [{'name': 'Shi X Y, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Armed Police General Hospital, P.R. China', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cellonis Biotechnology Co. Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Cellonis Biotechnology Co. Ltd.', 'oldOrganization': 'others'}}}}