Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2026-02-20 @ 12:41 PM
Study NCT ID:
NCT02824393
Status:
COMPLETED
Last Update Posted:
2018-07-18
First Post:
2016-06-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Experimental Autologous Mesenchymal Stem Cell Therapy in Treatment of Chronic Autoimmune Urticaria
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014581', 'term': 'Urticaria'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D000080223', 'term': 'Chronic Urticaria'}], 'ancestors': [{'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-17', 'studyFirstSubmitDate': '2016-06-29', 'studyFirstSubmitQcDate': '2016-07-01', 'lastUpdatePostDateStruct': {'date': '2018-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in weekly urticaria activity scores.', 'timeFrame': '6 months', 'description': 'The weekly urticaria activity scores will be assessed according to European Academy of Allergy and Clinical Immunology (EAACI) / Global Allergy and Asthma European Network (GALEN) guidelines.'}], 'secondaryOutcomes': [{'measure': 'Follow-up of the mesenchymal stem cell treatment-related side effects according to World Health Organisation (WHO) Toxicity Grading Scale for Determining The Severity of Adverse Events.', 'timeFrame': '12 months'}, {'measure': 'The changes in the ratios of peripheral blood cluster of differentiation 4 (CD4) T cell subsets.', 'timeFrame': '6 months'}, {'measure': 'The changes in ratios of peripheral blood inflammatory and anti-inflammatory cytokines.', 'timeFrame': '6 months'}, {'measure': 'The changes in the levels of peripheral blood anti-FcεRI autoantibody', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mesenchymal stem cell', 'Chronic autoimmune urticaria'], 'conditions': ['Urticaria', 'Autoimmune Diseases', 'Immune System Diseases', 'Skin Diseases']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to determine whether autologous adipose tissue derived Mesenchymal Stem Cells of treatment for chronic autoimmune urticaria is safe and effective.', 'detailedDescription': "Chronic urticaria is a distressful disease, which negatively affects the quality of life. Pathogenesis isn't exactly clear, treatment is relatively palliative and results are usually suboptimal. 30-40% of the patients have autoimmune origin. Patients are forced to use immunosuppressive treatments which have systemic effects. Some of the treatments have effects as severe as the disease itself.\n\nMesenchymal stem cells (MSCs) are the most common used cells in clinical trials. These cells can provide efficient immunosuppression in severe conditions like immunosuppressive resistant Graft versus Host Disease. With this study at the first time and quite a different approach from conventional treatment, it will be tried an experimental treatment that used in the MSCs for the chronic autoimmune urticaria patients without of definitive treatment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients diagnosed with chronic autoimmune urticaria (at least six months before)\n2. Patients who have \\>20 and over of urticaria activity score \\[according to European Academy of Allergy and Clinical Immunology (EAACI) / Global Allergy and Asthma European Network (GALEN) guidelines\\].\n3. Patients who capable of own daily findings record.\n4. Patients who could not be controlled despite the use of a treatment agent in the fourth step for 3 months (according to EAACI / GALEN guidelines).\n\nExclusion Criteria:\n\n1. Patients who have heart, liver or renal failure.\n2. Patients who have epilepsy, cerebrovascular or ischemic attack.\n3. Patients who have atopic dermatitis or another underlying itchy skin disease.\n4. Patients who have parasitic infection.\n5. Patients who have antibiotic allergy.\n6. History of malignancy.'}, 'identificationModule': {'nctId': 'NCT02824393', 'briefTitle': 'Experimental Autologous Mesenchymal Stem Cell Therapy in Treatment of Chronic Autoimmune Urticaria', 'organization': {'class': 'OTHER', 'fullName': 'Celal Bayar University'}, 'officialTitle': 'Experimental Autologous Mesenchymal Stem Cell Therapy in Treatment of Chronic Autoimmune Urticaria', 'orgStudyIdInfo': {'id': 'TUBITAK-1001-215S612'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mesenchymal stem cell', 'description': 'Intravenous infusion of ex vivo cultured adipose tissue derived autologous mesenchymal stem cells, twice at two week intervals in total 1x10/6 cells/kg.', 'interventionNames': ['Biological: Autologous mesenchymal stem cell']}, {'type': 'NO_INTERVENTION', 'label': 'Control patients', 'description': 'The patients who treated with the conventional therapy for urticaria, but not treat with mesenchymal stem cell.'}], 'interventions': [{'name': 'Autologous mesenchymal stem cell', 'type': 'BIOLOGICAL', 'otherNames': ['Autologous adipose tissue derived mesenchymal stem cell'], 'description': 'Intravenous infusion of ex vivo cultured adipose tissue derived autologous mesenchymal stem cells, twice at two week intervals in total 1x10/6 cells/kg.', 'armGroupLabels': ['Mesenchymal stem cell']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Manisa', 'country': 'Turkey (Türkiye)', 'facility': 'Celal Bayar University, Medical School', 'geoPoint': {'lat': 38.61202, 'lon': 27.42647}}], 'overallOfficials': [{'name': 'Alper Tunga Özdemir, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ege University, Institute of Health Sciences, Department of Stem Cell, Izmir/TURKEY'}, {'name': 'Ercüment Ovalı, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Acıbadem Labcell, Istanbul/TURKEY'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Celal Bayar University', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Scientific and Technological Research Council of Turkey', 'class': 'OTHER'}, {'name': 'Acıbadem Labcell', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Doctor (MD)', 'investigatorFullName': 'Cengiz Kırmaz', 'investigatorAffiliation': 'Celal Bayar University'}}}}