Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2026-01-01 @ 2:00 AM
Study NCT ID:
NCT05003934
Status:
RECRUITING
Last Update Posted:
2025-04-08
First Post:
2021-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for RA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Mexico']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System 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': '2021-11-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-04', 'studyFirstSubmitDate': '2021-08-06', 'studyFirstSubmitQcDate': '2021-08-06', 'lastUpdatePostDateStruct': {'date': '2025-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09', '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: the 28-joint disease activity score (DAS 28)', 'timeFrame': 'Four year follow-up', 'description': 'DAS 28 is used to determine the disease activity for RA. It will be completed for each follow up point.'}, {'measure': 'Efficacy: visual analog scale (VAS)', 'timeFrame': 'Four year follow-up', 'description': 'VAS is a scale that is used to measure pain. It will be completed for each follow up point.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '18490431', 'type': 'BACKGROUND', 'citation': 'Wells G, Becker JC, Teng J, Dougados M, Schiff M, Smolen J, Aletaha D, van Riel PL. Validation of the 28-joint Disease Activity Score (DAS28) and European League Against Rheumatism response criteria based on C-reactive protein against disease progression in patients with rheumatoid arthritis, and comparison with the DAS28 based on erythrocyte sedimentation rate. Ann Rheum Dis. 2009 Jun;68(6):954-60. doi: 10.1136/ard.2007.084459. Epub 2008 May 19.'}, {'pmid': '30211382', 'type': 'BACKGROUND', 'citation': 'Delgado DA, Lambert BS, Boutris N, McCulloch PC, Robbins AB, Moreno MR, Harris JD. Validation of Digital Visual Analog Scale Pain Scoring With a Traditional Paper-based Visual Analog Scale in Adults. J Am Acad Orthop Surg Glob Res Rev. 2018 Mar 23;2(3):e088. doi: 10.5435/JAAOSGlobal-D-17-00088. eCollection 2018 Mar.'}, {'pmid': '31908418', 'type': 'BACKGROUND', 'citation': 'Wang L, Huang S, Li S, Li M, Shi J, Bai W, Wang Q, Zheng L, Liu Y. Efficacy and Safety of Umbilical Cord Mesenchymal Stem Cell Therapy for Rheumatoid Arthritis Patients: A Prospective Phase I/II Study. Drug Des Devel Ther. 2019 Dec 19;13:4331-4340. doi: 10.2147/DDDT.S225613. eCollection 2019.'}, {'pmid': '30551438', 'type': 'BACKGROUND', 'citation': 'Ghoryani M, Shariati-Sarabi Z, Tavakkol-Afshari J, Ghasemi A, Poursamimi J, Mohammadi M. Amelioration of clinical symptoms of patients with refractory rheumatoid arthritis following treatment with autologous bone marrow-derived mesenchymal stem cells: A successful clinical trial in Iran. Biomed Pharmacother. 2019 Jan;109:1834-1840. doi: 10.1016/j.biopha.2018.11.056. Epub 2018 Nov 26.'}]}, '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 Rheumatoid Arthritis', 'detailedDescription': "Studies have shown that stem cell treatment is safe and efficacious for the treatment of Rheumatoid Arthritis (RA). Patients with RA 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 Rheumatoid Arthritis\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': 'NCT05003934', 'briefTitle': 'Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for RA', '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 Rheumatoid Arthritis', 'orgStudyIdInfo': {'id': 'SC-8-ATG-10-03'}}, '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'}}}}