Ignite Creation Date:
2025-12-24 @ 11:46 PM
Ignite Modification Date:
2025-12-31 @ 1:05 PM
Study NCT ID:
NCT01068951
Status:
COMPLETED
Last Update Posted:
2014-02-05
First Post:
2010-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Patients With Newly Onset of Type 1 Diabetes With Mesenchymal Stem Cells
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], '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'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-04', 'studyFirstSubmitDate': '2010-02-16', 'studyFirstSubmitQcDate': '2010-02-16', 'lastUpdatePostDateStruct': {'date': '2014-02-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The concentration of stimulated c-peptide at 90 minutes after the start of a mixed meal tolerance test at 365+/-10 days following the infusion or not with mesenchymal stem cells', 'timeFrame': '1 year after intervention'}]}, 'conditionsModule': {'keywords': ['type 1 diabetes', 'mesenchymal stem cells', 'intervention'], 'conditions': ['Type 1 Diabetes']}, 'referencesModule': {'references': [{'pmid': '25204974', 'type': 'DERIVED', 'citation': 'Carlsson PO, Schwarcz E, Korsgren O, Le Blanc K. Preserved beta-cell function in type 1 diabetes by mesenchymal stromal cells. Diabetes. 2015 Feb;64(2):587-92. doi: 10.2337/db14-0656. Epub 2014 Sep 9.'}]}, 'descriptionModule': {'briefSummary': 'The main hypothesis of the investigators study is that the development of autoimmune diabetes may be halted att diagnosis by the immune modulatory properties of mesenchymal stem cells.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ability to provide written informed consent\n* Mentally stable and able to comply with the procedures of the study protocol\n* Clinical history compatible with type 1 diabetes diagnosed less than 10 days of enrolment Stimulate c-peptide \\>0.1 nmol/l\n\nExclusion Criteria:\n\n* Patients with BMI\\>30\n* Patients with unstable cardiovascular status\n* Patients with active infections, unless treatment is not judged necessary by the investigators\n* Patients with serological evidence of infection with HIV, hepatitis B or hepatitis C.\n* Sexually active females who are not a) postmenopausal, b) surgically sterile or c) using an acceptable method of contraception: oral contraceptives, Norplant, Depo-provera and barrier devices combined with spermicidal gel are acceptable.\n* Patients with known or previous malignancy. Patient with any condition or any circumstance that in the opinion of the investigator would make it unsafe to undergo treatment with autologous MSC.'}, 'identificationModule': {'nctId': 'NCT01068951', 'briefTitle': 'Treatment of Patients With Newly Onset of Type 1 Diabetes With Mesenchymal Stem Cells', 'organization': {'class': 'OTHER', 'fullName': 'Uppsala University Hospital'}, 'officialTitle': 'Open Study to Evaluate the Safety and Efficacy of Autologous Mesenchymal Stem Cells in Treatment of Recently Diagnosed Patients With Type 1 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'AS2010-0180'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Mesenchymal stem cells', 'description': 'Comparison of active treatment with autologous mesenchymal stem cells (in addition to standard treatment) to standard treatment of patients newly diagnosed with type 1 diabetes mellitus.', 'interventionNames': ['Biological: Mesenchymal stem cells']}, {'type': 'NO_INTERVENTION', 'label': 'Control'}], 'interventions': [{'name': 'Mesenchymal stem cells', 'type': 'BIOLOGICAL', 'description': 'Autologous transplantation of the patients own mesenchymal stem cells (approximately 2 x 106 cells/kg body weight) intravenously.', 'armGroupLabels': ['Mesenchymal stem cells']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE-75185', 'city': 'Uppsala', 'country': 'Sweden', 'facility': 'Uppsala University Hospital', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}], 'overallOfficials': [{'name': 'Per-Ola Carlsson, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Uppsala University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uppsala University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Per-Ola Carlsson', 'investigatorAffiliation': 'Uppsala University Hospital'}}}}