Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2025-12-25 @ 7:10 PM
Study NCT ID:
NCT03454932
Status:
TERMINATED
Last Update Posted:
2020-06-11
First Post:
2015-06-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Research Study on the Immunosuppressive Effects of a Cell Therapy Product on PBMC Isolated From Blood of Patients With Inflammatory Rheumatic Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Belgium']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D015535', 'term': 'Arthritis, Psoriatic'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D011565', 'term': 'Psoriasis'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'limited number of recruited patients', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2017-06-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-09', 'studyFirstSubmitDate': '2015-06-03', 'studyFirstSubmitQcDate': '2018-02-27', 'lastUpdatePostDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PBMC proliferation, as assessed with PBMC assay', 'timeFrame': '7 days', 'description': 'Freshly prepared cell therapy product and PBMC will be mixed together in wells. Mixes will be incubated for 7 days in a humidified atmosphere of 5% CO2 in air at 37°C. PBMC proliferation will be assessed using tritiated (³H)-thymidine uptake (β-counter).'}, {'measure': 'Secretion of pro-inflammatory cytokines (e.g., IL-1β) and anti- inflammatory cytokines (e.g., IL-10), as assessed with PBMC assay', 'timeFrame': '7 days', 'description': 'Freshly prepared cell therapy product and PBMC will be mixed together in wells. Mixes will be incubated for 7 days in a humidified atmosphere of 5% CO2 in air at 37°C. Pro-inflammatory cytokines (e.g., IL-1β) and anti- inflammatory cytokines (e.g., IL-10) will be measured in culture supernatant using Luminex method.'}], 'secondaryOutcomes': [{'measure': 'Record of past and current relevant medical history through questionnaire', 'timeFrame': 'time of first visit'}, {'measure': 'Record of concomitant medications through questionnaire', 'timeFrame': 'time of first visit'}, {'measure': 'Record of disease activity assessment (DAS28 and/or CASPAR and/or ASDAS and/or NY)', 'timeFrame': 'time of first visit'}, {'measure': 'Record of any adverse events (if any)', 'timeFrame': 'time of first visit', 'description': 'occurring during and/or after the blood sample collection procedure'}, {'measure': 'Results of the laboratory blood tests for CBC, RF, CRP, HLA-B27', 'timeFrame': '7 days', 'description': 'Complete Blood Count (CBC), formula and electrolytes; Rheumatoid Factor (RF); C-Reactive Protein (CRP); HLA-B27'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Rheumatoid Arthritis', 'Psoriatic Arthritis', 'Spondylarthritis', 'Rheumatic diseases', 'Inflammation', 'Autoimmune diseases', 'Osteoimmunology'], 'conditions': ['Rheumatoid Arthritis', 'Psoriatic Arthritis', 'Spondylarthritis']}, 'descriptionModule': {'briefSummary': "Rheumatic diseases regroup a variety of disorders affecting the locomotor system including joints, muscles, connective tissues and soft tissues around the joints and bones. Inflammation and/or autoimmune reactions contribute to the aetiology of many rheumatic diseases. Such autoimmune conditions, commonly referred to as inflammatory rheumatic diseases (IRD), include arthritis of various origins such as rheumatoid arthritis (RA), psoriatic arthritis (PsA) or spondylarthritis (SpA). Patients with autoimmune diseases such as RA or SpA are in higher risk of fractures compared to the general population.\n\nInitial pharmacotherapies for IRD remain NSAID treatment for pain relief, and anti-resorptive agents (e.g., TNF-alpha blockers) which aim at reducing bone loss and preventing occurrence of new bone erosions. Yet current treatments may have strong side effects and are not always effective (e.g., 35-40% of the patients treated with TNF-alpha inhibitors will initially or progressively loose response). Therefore there is a need for further treatment modalities in IRD, which would focus on both suppressing inflammation and treating bone disorders.\n\nCurrent research studies indicate that Bone Therapeutics' allogeneic osteoblastic cells exhibit in vitro potent immunosuppressive and anti-inflammatory properties (in addition to osteo-regenerative and immune-privileged properties).\n\nThe present research study aims at investigating in vitro the properties of these osteoblastic cells in the context of inflammatory rheumatic diseases. In this purpose, in vitro assays will be used to test these immunosuppressive effects on peripheral blood mononuclear cells (PBMCs) of subjects diagnosed with RA, PsA and SpA."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Rheumatoid Arthritis, Psoriatic Arthritis and Spondylarthritis Subjects', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects of 18 years of age or older\n* Subjects must belong to one of this group: Rheumatoid Arthritis (RA) Subjects OR Psoriatic Arthritis (PsA) Subjects OR Spondylarthritis (SpA) Subjects\n\nExclusion Criteria:\n\n* Subjects diagnosed with other autoimmune/inflammatory diseases other than Crohn's disease, psoriasis, uveitis, Sjögren's syndrome and auto-immune thyroiditis\n* Subjects with an active cancer and currently receiving a cancer treatment\n* Women with known pregnancy\n* Breastfeeding women\n* Subjects with a known history of HIV and/or Hepatitis B and/or Hepatitis C infection and/or positive for HBs antigens"}, 'identificationModule': {'nctId': 'NCT03454932', 'briefTitle': 'Research Study on the Immunosuppressive Effects of a Cell Therapy Product on PBMC Isolated From Blood of Patients With Inflammatory Rheumatic Diseases', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bone Therapeutics S.A'}, 'officialTitle': 'Laboratory Research Study of the Immunosuppressive Effect of a Cell Therapy Product on PBMC Isolated From Blood of Patients With Inflammatory Rheumatic Diseases', 'orgStudyIdInfo': {'id': 'RAPSASPA-HBM'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Rheumatoid Arthritis', 'description': 'Patients with Rheumatoid Arthritis', 'interventionNames': ['Other: Blood sampling']}, {'label': 'Psoriatic Arthritis', 'description': 'Patients with Psoriatic Arthritis', 'interventionNames': ['Other: Blood sampling']}, {'label': 'Spondylarthritis', 'description': 'Patients with Spondylarthritis', 'interventionNames': ['Other: Blood sampling']}], 'interventions': [{'name': 'Blood sampling', 'type': 'OTHER', 'armGroupLabels': ['Psoriatic Arthritis', 'Rheumatoid Arthritis', 'Spondylarthritis']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bone Therapeutics S.A', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}