Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2025-12-28 @ 2:04 PM
Study NCT ID:
NCT01157403
Status:
UNKNOWN
Last Update Posted:
2013-06-18
First Post:
2010-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Autologous Transplantation of Mesenchymal Stem Cells for Treatment of Patients With Onset of Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014182', 'term': 'Transplantation, Autologous'}], 'ancestors': [{'id': 'D014180', 'term': 'Transplantation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2014-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-06-15', 'studyFirstSubmitDate': '2010-07-02', 'studyFirstSubmitQcDate': '2010-07-06', 'lastUpdatePostDateStruct': {'date': '2013-06-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'C peptide release test', 'timeFrame': '6 Months after intervention', 'description': 'The concentration of c-peptide at 90 minutes after the start of the C-peptide release test at 24 Months following the infusion or not with bone marrow mesenchymal stem cells'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['mesenchymal stem cells'], 'conditions': ['Evidence of Liver Transplantation']}, 'descriptionModule': {'briefSummary': 'Type 1 diabetes mellitus (T1DM)is characterized by the autoimmune destruction of the pancreatic β cells; as a result, patients with T1DM are dependent on exogenous insulin to control their blood glucose continuously. Bone marrow-derived mesenchymal stem cells has been shown in many animal studies their potential cure for T1DM,which could not only address the need for β-cell replacement but also control of the autoimmune response to cells which express insulin. Therefore it is need to study the safety and efficacy of autologous bone marrow mesenchymal stem cells in treatment of newly diagnosed patients with T1DM.', 'detailedDescription': 'Autologous transplantation of Bone marrow mesenchymal stem cells(approximately 2.5 x 106 cells/kg body weight) intravenously'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Ability to provide written informed consent from patients or Child guardian\n2. Confirmed diagnosis of type 1 diabetes by ADA criteria less than 18 weeks •\n\nExclusion Criteria:\n\n1. Body Mass Index \\>30\n2. Presence of acute stage as Active infection,recent myocardial infarction, recent cerebral vascular accident (CVA) or acute renal failure.\n3. Severe Organ damage(e.g. lung disease, or hematopoietic dysfunction, or liver dysfunction).\n4. Infectious diseases, e.g. HIV infection, or hepatitis B or C infection\n5. Presence of malignancy'}, 'identificationModule': {'nctId': 'NCT01157403', 'briefTitle': 'Autologous Transplantation of Mesenchymal Stem Cells for Treatment of Patients With Onset of Type 1 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Third Military Medical University'}, 'officialTitle': 'Autologous Transplantation of Mesenchymal Stem Cells for Treatment of Patients With Onset of Type 1 Diabetes', 'orgStudyIdInfo': {'id': 'ldb201001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'mesenchymal stem cells', 'description': 'To study the safety and efficacy of autologous transplantation of bone marrow mesenchymal stem cells in treatment of newly diagnosed patients with T1DM.', 'interventionNames': ['Biological: Autologous transplantation']}], 'interventions': [{'name': 'Autologous transplantation', 'type': 'BIOLOGICAL', 'otherNames': ['SWH2010A19'], 'description': 'Autologous transplantation of bone marrow mesenchymal stem cells (approximately 2.5 x 106 cells/kg body weight) intravenously', 'armGroupLabels': ['mesenchymal stem cells']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400038', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chen Bing, doctor', 'role': 'CONTACT', 'email': 'cb@mail.tmmu.com.cn'}, {'name': 'Lu Debin, doctor', 'role': 'CONTACT', 'email': 'ldb2005056@yahoo.COM.CN'}], 'facility': 'Endocrine Department, the south west Hospital of the Third Military Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'centralContacts': [{'name': 'Chen bing, doctor', 'role': 'CONTACT', 'email': '903262619@qq.com'}, {'name': 'lu debin, doctor', 'role': 'CONTACT', 'email': 'ldb2005056@yahoo.com.cn'}], 'overallOfficials': [{'name': 'chen bing, doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Endocrine Department, the south west Hospital of the Third Military Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lu Debin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Southwest Hospital', 'investigatorFullName': 'Lu Debin', 'investigatorAffiliation': 'Third Military Medical University'}}}}