Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2026-02-08 @ 3:03 PM
Study NCT ID:
NCT06748651
Status:
RECRUITING
Last Update Posted:
2024-12-27
First Post:
2024-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intra-articular Allocetra in Osteoarthritis of the of the Temporomandibular Joint (TMJ)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'The study will consist of two stages, during which a single treatment of Allocetra, will be administered via intra-articular injection into the target temporomandibular joint .'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-04-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-26', 'studyFirstSubmitDate': '2024-12-13', 'studyFirstSubmitQcDate': '2024-12-26', 'lastUpdatePostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Exploratory outcome: Assessment of TMJ function by examination', 'timeFrame': 'Screening to 12 months', 'description': 'Number of patients with pain on palpation, clicking/crepitation, or mandibular mobility.'}], 'primaryOutcomes': [{'measure': 'Number and severity of AEs, SAEs and injection reactions following treatment', 'timeFrame': 'Day 0 to 12 month', 'description': 'Number and severity of AEs, SAEs and following treatment, and injection-related reactions occurring during study treatment injection, including injection interruption/discontinuation.'}], 'secondaryOutcomes': [{'measure': 'Patient reported pain in the target TMJ', 'timeFrame': 'Screening to 6 months', 'description': 'Change from baseline in patient reported pain Numerical Rating Scale (NRS) in the target TMJ at 3 months and 6 months following treatment.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ALLOCETRA', 'Temporomandibular', 'Osteoarthritis', 'TMJ', 'Macrophages', 'Cell therapy'], 'conditions': ['Temporomandibular Joint Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'This study is a single center trial to assess the safety and initial efficacy of intra-articular administration of Allocetra to patients with Temporomandibular Joint Osteoarthritis (TMJ-OA)', 'detailedDescription': 'The temporomandibular joint (TMJ) is a critical synovial joint enabling jaw movement. TMJ osteoarthritis results from factors such as disc dislocation, trauma, overuse, or developmental anomalies, affecting all joint structures, including cartilage, synovium, bone, and ligaments. Key pathological features include chondrocyte loss, extracellular matrix degradation, and subchondral bone remodeling. TMJ-OA progresses gradually through phases of activity and remission, ultimately leading to a burnout phase.\n\nAllocetra is an immunomodulatory cell-based therapy consisting of allogeneic peripheral blood mononuclear cells that have been modified to be engulfed by macrophages and reprogram them into their homeostatic state.\n\nThis study is a single center, open lable safety and initial efficacy trial to assess intra-articular administration of Allocetra in patients with TMJ-OA who have not responded sufficiently to conventional therapies.\n\nThe study is comprised of two stages, during which a single treatment of Allocetra, will be administered via intra-articular injection into the target temporomandibular joint.\n\nPatients will be followed for up to a year following treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosed with temporomandibular OA in the target TMJ.\n2. Inflammatory findings by Magnetic Resonance Imaging (MRI).\n3. Acceptable blood workup results (CBC, electrolytes, kidney and liver function).\n\nExclusion Criteria:\n\n1. Prior intra-articular injection to the target TMJ within 3 months prior to treatment.\n2. Any significant injury or surgery to the target TMJ.\n3. Evidence of active local infection in the vicinity of the target TMJ or clinically significant active infection anywhere in the body.\n4. Patients with a known neurological disease or rheumatic condition, a major medical condition that would affect quality of life and influence the results of the study, or other pain of unknown etiology.'}, 'identificationModule': {'nctId': 'NCT06748651', 'briefTitle': 'Intra-articular Allocetra in Osteoarthritis of the of the Temporomandibular Joint (TMJ)', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': 'Evaluation of Allocetra by Intra-articular Injection for the Treatment of Temporomandibular Joint Osteoarthritis (TMJ-OA)', 'orgStudyIdInfo': {'id': '1400-24-SMC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intra-articular Injection of Allocetra performed once on Day 1 of the study', 'interventionNames': ['Drug: Allocetra']}], 'interventions': [{'name': 'Allocetra', 'type': 'DRUG', 'description': 'Intra-articular injection of Allocetra performed once on Day 1 of the study', 'armGroupLabels': ['Intra-articular Injection of Allocetra performed once on Day 1 of the study']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ramat Gan', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Amit Druyan, MD', 'role': 'CONTACT', 'email': 'amit.druyan@sheba.health.gov.il', 'phone': '+972-52-3359665'}, {'name': 'Amit Druyan, MD', 'role': 'CONTACT'}], 'facility': 'Sheba Medical Center', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}], 'centralContacts': [{'name': 'Amit Druyan, Dr.', 'role': 'CONTACT', 'email': 'Amit.Druyan@sheba.health.gov.il', 'phone': '972-3-5304413'}, {'name': 'Tehila Biton', 'role': 'CONTACT', 'email': 'tehila.biton@sheba.health.gov.il', 'phone': '972-3-5304413'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. Amit Druyan', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dr. Amit Druyan', 'investigatorAffiliation': 'Sheba Medical Center'}}}}