Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2026-02-24 @ 1:15 AM
Study NCT ID:
NCT02940418
Status:
UNKNOWN
Last Update Posted:
2019-07-24
First Post:
2016-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Stem Cells in Diabetes Mellitus Type 1
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': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-02-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2020-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-07-23', 'studyFirstSubmitDate': '2016-10-19', 'studyFirstSubmitQcDate': '2016-10-19', 'lastUpdatePostDateStruct': {'date': '2019-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety of using allogenic ASC assessed by any adverse events', 'timeFrame': '6 months', 'description': 'Patients will be assessed for any adverse events as a result of the injection.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetes Mellitus', 'Type 1', 'Adipose derived mesenchymal stem cells'], 'conditions': ['Diabetes Mellitus Type 1']}, 'descriptionModule': {'briefSummary': 'Allogenic adipose derived mesenchymal stem cells will be injected into patients newly diagnosed with type 1 Diabetes Mellitus', 'detailedDescription': 'Adipose derived mesenchymal stem cells (ASCs) are to be collected from blood group O donor, cells will be passaged to passage 5.\n\nBefore release the sample will be subject to our release criteria which include: testing for any bacterial or fungal growth as well as endotoxin and mycoplasma. All these tests must be negative. In addition the cell count and viability (must be more than 80%) are done before release. Surface markers documentation is done on the cells before release using flow cytometry.\n\nThe cells should be infused within 2 hours of release. The dose to is to be repeated after 6 months of a total of two doses in patients. Tests and follow up are to be one at week 12, 24 and 36 when the study is stopped.\n\nThese cells will be injected intravenously into patients newly diagnosed with type 1 Diabetes Mellitus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult Patients with Type 1 Diabetes Mellitus.\n2. Age from 18 years to 35 years either gender.\n3. Duration of disease: not exceeding 3 years unless C-peptide is not less than 0.5 ng/ml\n4. C-Peptide at inclusion base line should not be less than 0.5 ng/ml\n5. No clinical evidence of renal, retinal, vascular or skin complications\n6. Body Mass Index not exceeding 30\n7. Any HbA1c\n8. At least one positive antibody either anti-Glutamic Acid Decarboxylase-65 or Insulinoma-Associated-2 Autoantibodies (anti-1A2)\n9. Informed Consent by patient\n\nExclusion Criteria:\n\n1. Age less than 18 years and more than 35 years\n2. Pregnancy\n3. Married women or women expected to be married within the study period\n4. History of allergy, Cancer, bronchial asthma, liver disease or hepatitis\n5. Diabetic coma or pre-coma current or recent within the last 2 months\n6. C-Peptide less than 0.5 ng/ml\n7. Disease duration more than 3 yrs.\n8. Complication mentioned in 5 above in inclusion\n9. Non-consenting patient or withdrawal of consent.\n10. Bleeding disorders'}, 'identificationModule': {'nctId': 'NCT02940418', 'briefTitle': 'Use of Stem Cells in Diabetes Mellitus Type 1', 'organization': {'class': 'OTHER', 'fullName': 'University of Jordan'}, 'officialTitle': 'The Use of Mesenchymal Stromal Cells (MSC) in Type 1 Diabetes Mellitus in Adult Humans: Phase I Clinical Trial', 'orgStudyIdInfo': {'id': 'T1DM.UJCTC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dose 1 mil/kg', 'description': 'Adipose mesenchymal cells with bone marrow mononuclear cells.\n\nTwo doses with a 6 month interval of allogenic Adipose mesenchymal cells +1 mil/kg of autologous bone marrow mononuclear cells will be injected intravenously.', 'interventionNames': ['Biological: Adipose mesenchymal cells with bone marrow mononuclear cells']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dose 10 mil/kg', 'description': 'Adipose mesenchymal cells with bone marrow mononuclear cells.\n\nTwo doses with a 6 month interval of allogenic Adipose mesenchymal cells +10 mil/kg of autologous bone marrow mononuclear cells will be injected intravenously.', 'interventionNames': ['Biological: Adipose mesenchymal cells with bone marrow mononuclear cells']}], 'interventions': [{'name': 'Adipose mesenchymal cells with bone marrow mononuclear cells', 'type': 'BIOLOGICAL', 'description': 'Allogenic adipose-derived mesenchymal cells with autologous bone marrow mononuclear cells will be injected.', 'armGroupLabels': ['Dose 1 mil/kg', 'Dose 10 mil/kg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11942', 'city': 'Amman', 'status': 'RECRUITING', 'country': 'Jordan', 'contacts': [{'name': 'Abdalla Awidi, MD', 'role': 'CONTACT', 'email': 'abdalla.awidi@gmail.com', 'phone': '0096265355000', 'phoneExt': '23960'}], 'facility': 'Cell Therapy Center', 'geoPoint': {'lat': 31.95522, 'lon': 35.94503}}], 'centralContacts': [{'name': 'Hanan D. Jafar, PhD', 'role': 'CONTACT', 'email': 'hanan.jafar@gmail.com', 'phone': '00962798871087'}], 'overallOfficials': [{'name': 'Abdallah Awidi, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cell Therapy Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sophia Al-Adwan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Biologist, PhD', 'investigatorFullName': 'Sophia Al-Adwan', 'investigatorAffiliation': 'University of Jordan'}}}}