Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2026-02-12 @ 6:41 AM
Study NCT ID:
NCT02975960
Status:
COMPLETED
Last Update Posted:
2018-01-25
First Post:
2016-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ADMSCs for the Treatment of Systemic Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012595', 'term': 'Scleroderma, Systemic'}, {'id': 'C000721267', 'term': 'digital ulcers'}, {'id': 'D005734', 'term': 'Gangrene'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2018-01-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-23', 'studyFirstSubmitDate': '2016-11-09', 'studyFirstSubmitQcDate': '2016-11-23', 'lastUpdatePostDateStruct': {'date': '2018-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline modified Rodnan Skin score (mRSS) of hands at 12 weeks', 'timeFrame': 'baseline, 12 weeks', 'description': 'Assess hands mRSS'}], 'secondaryOutcomes': [{'measure': "Change from baseline Raynaud's condition score at 12 weeks", 'timeFrame': 'baseline, 12 weeks', 'description': "The severity (frequency and intensity of crises) of Raynaud's phenomenon"}, {'measure': 'Change from baseline Visual Analog Score for pain the hands at 12 weeks', 'timeFrame': 'baseline, 12 weeks', 'description': 'Patient report hand pain degree, comparing baseline and 12 weeks'}, {'measure': 'Changes from baseline mRSS (total) at 12 weeks', 'timeFrame': 'baseline, 12 weeks', 'description': 'Assess total mRSS (including hands)'}, {'measure': 'Change from baseline Kapandji score at 12weeks', 'timeFrame': 'baseline, 12 weeks', 'description': 'assess the mobility of both hands'}, {'measure': 'Change from baseline Cochin hand function scale at 12 weeks', 'timeFrame': 'baseline, 12 weeks', 'description': 'Assess hand function (patients reported outcome)'}, {'measure': 'Change from baseline Systemic sclerosis HAQ at 12 weeks', 'timeFrame': 'baseline, 12 weeks', 'description': 'he quality of life- score adapted to systemic sclerosis'}, {'measure': 'Change from baseline peripheral vasculature at 12 weeks', 'timeFrame': 'baseline, 12 weeks', 'description': 'Assess peripheral vascularity by Nailfold capillaroscopy'}, {'measure': 'Change from baseline finger circumference at 12 weeks', 'timeFrame': 'baseline, 12 weeks', 'description': 'Measure second to fifth finger circumference'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['systemic sclerosis', 'adipose derived stem cell', 'stromal vascular fraction', 'digital ulcer', 'gangrene'], 'conditions': ['Systemic Sclerosis']}, 'descriptionModule': {'briefSummary': 'Systemic sclerosis (SSc) is a rare autoimmune disease, mainly characterized by cutaneous and visceral fibrosis. Digital ulcer and sclerosing skin are commonly affected on hands, but the treatment for these manifestations are often ineffective.\n\nAdipose tissue contains stromal vascular fraction (SVF), which is abundant multipotent stem cells, capable of tissue repair. A prior study (NCT01813279) has shown the safety and tolerance at 6 months of the subcutaneous injection of SVF in the fingers in SSc.\n\nThere are only few ways to manage SSc patients with skin lesion who already have treated with several medications (including vasodilators, PDE5 inhibitor, endothelin receptor antagonist) but some times their skin lesions are critical physically and emotionally.\n\nAutologous SVF injection could be one of the treatment options to treat skin lesion of SSc. Thus, the investigators study the efficacy and potential adverse event in Korean patients with SSc.', 'detailedDescription': 'In this study, the investigators will inject autologous Stromal vascular fraction.\n\n1\\) Acquiring autologous stromal vascular fraction by plastic surgeon\n\n1. Liposuction\n2. Extraction and purifying SVF using Smart-X system (15-20 min)\n3. Making syringe filled with autologous SVF\n\n2\\) SVF injection\n\nInject SVF subcutaneously with 25G needle in finger'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients who fulfill 2013 American college of Rheumatology/ European League Against Rheumatism Criteria for the classification of systemic sclerosis.\n2. The skin lesion was not improved after 6 months treatment with conventional therapy.\n\nExclusion Criteria:\n\n1. Pregnancy\n2. Start new medications within 3 months prior to enrollment\n3. Previous sympathectomy or amputation\n4. Current systemic infection\n5. AIDS, Syphilis, hepatitis B\\&C\n6. BMI \\<17kg/m2\n7. Cognitive dysfunction and other psychologic problems'}, 'identificationModule': {'nctId': 'NCT02975960', 'briefTitle': 'ADMSCs for the Treatment of Systemic Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'The Catholic University of Korea'}, 'officialTitle': 'Adipose Tissue-derived Mesenchymal Stem Cells for Cell-based Therapy in the Treatment of Systemic Sclerosis', 'orgStudyIdInfo': {'id': 'KC16TISI0343'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stromal vascular fraction injection', 'description': 'Injection of autologous stromal vascular fraction on hand.', 'interventionNames': ['Biological: injection of autologous stromal vascular fraction']}], 'interventions': [{'name': 'injection of autologous stromal vascular fraction', 'type': 'BIOLOGICAL', 'description': '1. Acquiring autologous stromal vascular fraction (SVF) from liposuction\n2. purifying SVF from lipoaspirates and making syringe filled with SVF\n3. SVF injection - Inject SVF on fingers subcutaneously.', 'armGroupLabels': ['Stromal vascular fraction injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06591', 'city': 'Seoul', 'country': 'South Korea', 'facility': "Seoul St. Mary's hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jung Hee Koh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Seoul St.Mary's hospital, The Catholic university of Korea"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Catholic University of Korea', 'class': 'OTHER'}, 'collaborators': [{'name': "Seoul St. Mary's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor, Principal Investigator', 'investigatorFullName': 'Jung Hee Koh', 'investigatorAffiliation': 'The Catholic University of Korea'}}}}