Ignite Creation Date:
2025-12-24 @ 8:01 PM
Ignite Modification Date:
2025-12-29 @ 3:21 PM
Study NCT ID:
NCT05016804
Status:
RECRUITING
Last Update Posted:
2025-04-08
First Post:
2021-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell IV Infusion for Systemic Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Mexico']}, 'conditionBrowseModule': {'meshes': [{'id': 'D012595', 'term': 'Scleroderma, Systemic'}, {'id': 'D045743', 'term': 'Scleroderma, Diffuse'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-04', 'studyFirstSubmitDate': '2021-08-17', 'studyFirstSubmitQcDate': '2021-08-17', 'lastUpdatePostDateStruct': {'date': '2025-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety (adverse events)', 'timeFrame': 'Four year follow-up', 'description': 'Clinical monitoring of possible adverse events or complications'}], 'secondaryOutcomes': [{'measure': 'Efficacy: skin score', 'timeFrame': 'Four year follow-up', 'description': 'It will be completed for each follow up point.'}, {'measure': 'Efficacy: Forced vital capacity (FVC)', 'timeFrame': 'Four year follow-up', 'description': 'It will be completed for each follow up point.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Systemic Sclerosis', 'Scleroderma', 'stem cell treatment'], 'conditions': ['Systemic Sclerosis']}, 'referencesModule': {'references': [{'pmid': '19605370', 'type': 'BACKGROUND', 'citation': 'Kaldas M, Khanna PP, Furst DE, Clements PJ, Kee Wong W, Seibold JR, Postlethwaite AE, Khanna D; investigators of the human recombinant relaxin and oral bovine collagen clinical trials. Sensitivity to change of the modified Rodnan skin score in diffuse systemic sclerosis--assessment of individual body sites in two large randomized controlled trials. Rheumatology (Oxford). 2009 Sep;48(9):1143-6. doi: 10.1093/rheumatology/kep202. Epub 2009 Jul 14.'}, {'pmid': '25114060', 'type': 'BACKGROUND', 'citation': 'Granel B, Daumas A, Jouve E, Harle JR, Nguyen PS, Chabannon C, Colavolpe N, Reynier JC, Truillet R, Mallet S, Baiada A, Casanova D, Giraudo L, Arnaud L, Veran J, Sabatier F, Magalon G. Safety, tolerability and potential efficacy of injection of autologous adipose-derived stromal vascular fraction in the fingers of patients with systemic sclerosis: an open-label phase I trial. Ann Rheum Dis. 2015 Dec;74(12):2175-82. doi: 10.1136/annrheumdis-2014-205681. Epub 2014 Aug 11.'}, {'pmid': '30616671', 'type': 'BACKGROUND', 'citation': 'Del Papa N, Di Luca G, Andracco R, Zaccara E, Maglione W, Pignataro F, Minniti A, Vitali C. Regional grafting of autologous adipose tissue is effective in inducing prompt healing of indolent digital ulcers in patients with systemic sclerosis: results of a monocentric randomized controlled study. Arthritis Res Ther. 2019 Jan 7;21(1):7. doi: 10.1186/s13075-018-1792-8.'}]}, 'descriptionModule': {'briefSummary': 'This trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of Systemic Sclerosis', 'detailedDescription': "Studies have shown that stem cell treatment is safe and efficacious for the treatment of Systemic Sclerosis. Patients with Systemic Sclerosis will receive a single intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells. The total dose will be 100 million cells. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.\n\nFor patients with more severe disease requiring chemotherapeutic drugs such as methotrexate, an autologous T Cell vaccine will be utilized created from the patient's own T cells obtained by apheresis."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of Systemic Sclerosis\n* Understanding and willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Active infection\n* Active cancer\n* Chronic multisystem organ failure\n* Pregnancy\n* Clinically significant Abnormalities on pre-treatment laboratory evaluation\n* Medical condition that would (based on the opinion of the investigator) compromise patient's safety.\n* Continued drug abuse\n* Pre-menopausal women not using contraception\n* Previous organ transplant\n* Hypersensitivity to sulfur"}, 'identificationModule': {'nctId': 'NCT05016804', 'briefTitle': 'Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell IV Infusion for Systemic Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'The Foundation for Orthopaedics and Regenerative Medicine'}, 'officialTitle': 'Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Systemic Sclerosis', 'orgStudyIdInfo': {'id': 'SC-10-ATG-12-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Group', 'description': 'Single intravenous infusion of 100 million cells', 'interventionNames': ['Biological: AlloRx']}], 'interventions': [{'name': 'AlloRx', 'type': 'BIOLOGICAL', 'description': 'cultured allogeneic adult umbilical cord derived mesenchymal stem cells', 'armGroupLabels': ['Treatment Group']}]}, 'contactsLocationsModule': {'locations': [{'city': "St John's", 'status': 'RECRUITING', 'country': 'Antigua and Barbuda', 'contacts': [{'name': 'Chadwick Prodromos, M.D.', 'role': 'CONTACT', 'email': 'care@thepsci.com', 'phone': '8476996810'}], 'facility': 'Medical Surgical Associates Center', 'geoPoint': {'lat': 17.12096, 'lon': -61.84329}}, {'city': 'Buenos Aires', 'status': 'RECRUITING', 'country': 'Argentina', 'contacts': [{'name': 'Chadwick Prodromos, M.D.', 'role': 'CONTACT', 'email': 'Care@thepsci.com', 'phone': '8476996810', 'phoneExt': '202'}], 'facility': 'Center for Investigation in Tissue Engineering and Cellular Therapy', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}], 'overallOfficials': [{'name': 'Chadwick Prodromos, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Foundation for Orthopaedics and Regenerative Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Foundation for Orthopaedics and Regenerative Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}