Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2026-01-11 @ 3:02 PM
Study NCT ID:
NCT03629002
Status:
UNKNOWN
Last Update Posted:
2018-08-14
First Post:
2018-08-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BIOLOGICAL EXPLORATION OF THE VASCULAR FRACTION FROM THE ADIPOSE TISSUE OF PATIENTS WITH SCLERODERMIA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012595', 'term': 'Scleroderma, Systemic'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Stromal vascular fraction obtained from adipose tissue.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2020-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-10', 'studyFirstSubmitDate': '2018-08-07', 'studyFirstSubmitQcDate': '2018-08-10', 'lastUpdatePostDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Study of the gene expression profile', 'timeFrame': '18 months', 'description': 'Study of the gene expression profile by qPCR'}], 'secondaryOutcomes': [{'measure': 'Phenotypic analysis of the cells composing the stromal vascular fraction', 'timeFrame': '18 months', 'description': 'Phenotypic analysis performed by flow cytometry after multiple immunolabelings (CD90, CD14, CD146, CD34, CD45, DRAQ5, NucBlue Fixed Cell Stain (DAPI)) performed in accordance with the recommendations of the International Society for Cellular Therapy (ISCT) and IFATS.'}, {'measure': 'Cell culture of the stromal vascular fraction to isolate and expand two populations of interest', 'timeFrame': '18 months', 'description': 'Mesenchymal stem cells (MSCs) obtained by culturing the total stromal vascular fraction without an immunomagnetic selection step.'}, {'measure': 'Cell culture of the stromal vascular fraction to isolate and expand two populations of interest', 'timeFrame': '18 months', 'description': 'Endothelial progenitors by a magnetic immuno-separation method (CD144 microbeads kit, Mylteni biotec) for specifically isolating and expanding endothelial progenitor cells.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Systemic Scleroderma']}, 'descriptionModule': {'briefSummary': 'The overall objective is to propose a comprehensive analysis of the biological properties of the stromal vascular fraction evaluated in the SCLERADEC 2 clinical trial (n = 15 available) and preserved in the biological collection, compared to healthy donors (n = 10). This characterization will focus on the exploration of the phenotypic and functional characteristics of the main cellular subpopulations present in the stromal vascular fraction of scleroderma patients likely to be associated with a better regenerative vascular or anti-fibrotic activity of the cell therapy product.\n\nThe main objective will be to validate whether the supposed mechanism of action of this innovative therapy, in relation to the representativity of the endothelial progenitors, carrying the vascular regeneration activity, is preserved in the sclerodermic context.\n\nA total of 30 subjects (20 systemic Scleroderma patients and 10 healthy donors) will be included.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with systemic scleroderma included in the SCLERADEC 2 trial and healthy volunteers who use a liposuction operation for aesthetic reasons.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nPatients with systemic scleroderma:\n\n* fulfilling the inclusion criteria for the SCLERADEC 2 trial: patients with systemic Scleroderma older than 18, desiring a therapeutic alternative and having a functional impotence authenticated by a functional index of Cochin's hand greater than 20.\n* having given their consent for the constitution of a sample in the biological collection\n* having completed the follow-up visit to M3 of the SCLERADEC 2 study to have responder / non-responder status.\n\nHealthy volunteers:\n\n* having recourse to a liposuction operation for aesthetic reasons,\n* with a BMI between 18 and 27,\n* not declaring chronic diseases,\n* having signed the non-opposition\n\nExclusion Criteria:\n\nPatients with systemic scleroderma:\n\n* Body mass index (weight-to-height ratio squared) less than 18\n* Major Sclerodactyly objectified by Rodnan score applied by hand\\> 16 (out of a total of 18 points)\n* Severe tendon retraction of the fingers objectified by a defect extension in passive measure in goniometry\\> 90 ° C for at least 2 proximal interphalangeal joints\n* Digital infection (including infected ulcer, ulcer with local inflammatory signs and clinical suspicion of osteitis)\n* Pulmonary arterial hypertension and / or progressive and / or oxygen-dependent pulmonary fibrosis\n* Prescription of a new systemic treatment for Systemic Scleroderma in the month prior to inclusion\n* Persons infected with HIV, HCV, HBV, HTLV and syphilis\n* Patients on immunosuppressants outside corticosteroid therapy \\<10 mg / day and methotrexate\n* Known hypersensitivity to human albumin\n\nFor healthy patients and volunteers:\n\n* Contraindication to surgery (patients on anticoagulant or antiaggregant, disorders of haemostasis, contraindication to the analgesic protocol used)\n* Premenopausal women of childbearing age without contraception\n* Minors\n* Pregnant or lactating women\n* Majors protected by law (under tutorship or curatorship)\n* Persons staying in a health or social facility\n* People in emergency\n* Persons deprived of their liberty\n* Inmates\n* Non-beneficiaries of a social security scheme\n* Absence or refusal of non-opposition"}, 'identificationModule': {'nctId': 'NCT03629002', 'acronym': 'sclerabio', 'briefTitle': 'BIOLOGICAL EXPLORATION OF THE VASCULAR FRACTION FROM THE ADIPOSE TISSUE OF PATIENTS WITH SCLERODERMIA', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique Hopitaux De Marseille'}, 'officialTitle': 'BIOLOGICAL EXPLORATION OF THE VASCULAR FRACTION FROM THE ADIPOSE TISSUE OF PATIENTS WITH SCLERODERMIA IN THE CONTEXT OF THE DEVELOPMENT OF AN INNOVATIVE CELLULAR THERAPY FOR THE TREATMENT OF FUNCTIONAL HANDICAP OF THE HAND', 'orgStudyIdInfo': {'id': '2018-06'}, 'secondaryIdInfos': [{'id': 'IDRCB', 'type': 'OTHER', 'domain': '2018-A00150-55'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients with systemic scleroderma', 'description': 'Use of the biological collection of the vascualire stromal fraction of the SCLERADEC 2 clinical trial.', 'interventionNames': ['Biological: Study of the gene expression profile']}, {'label': 'healthy volunteers', 'description': 'Recovery of a sample of adipose tissue during a liposuction operation in a context of routine cosmetic surgery.', 'interventionNames': ['Biological: Study of the gene expression profile']}], 'interventions': [{'name': 'Study of the gene expression profile', 'type': 'BIOLOGICAL', 'description': 'qPCR analysis', 'armGroupLabels': ['healthy volunteers', 'patients with systemic scleroderma']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13005', 'city': 'Marseille', 'country': 'France', 'facility': 'Direction de la Recherche Clinique et Innovation', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}], 'centralContacts': [{'name': 'Jérémy MAGALON', 'role': 'CONTACT', 'email': 'jeremy.magalon@ap-hm.fr'}, {'name': 'Alexandra GIULIANI', 'role': 'CONTACT', 'email': 'drci@ap-hm.fr', 'phone': '04 91 38 27 47'}], 'overallOfficials': [{'name': 'Jean-Olivier ARNAUD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistance Publique des Hopitaux de Marseille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique Hopitaux De Marseille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}