Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2026-04-16 @ 6:24 PM
Study NCT ID:
NCT02963727
Status:
UNKNOWN
Last Update Posted:
2021-04-28
First Post:
2016-11-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Wharton Jelly Derived Mesenchymal Stem Cells for Knee Osteoarthrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-01-25', 'releaseDate': '2023-05-09'}, {'resetDate': '2025-02-14', 'releaseDate': '2025-01-26'}, {'resetDate': '2025-04-24', 'releaseDate': '2025-04-07'}, {'resetDate': '2025-05-13', 'releaseDate': '2025-04-27'}], 'estimatedResultsFirstSubmitDate': '2023-05-09'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'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'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-01-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-27', 'studyFirstSubmitDate': '2016-11-10', 'studyFirstSubmitQcDate': '2016-11-10', 'lastUpdatePostDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of the safety and tolerability of the intra articular injection', 'timeFrame': '6 months', 'description': 'patients will be monitored for any adverse events resulting from the intraarticular injection of WJMSC'}], 'secondaryOutcomes': [{'measure': 'Assessment of the efficacy of intra-articular injection of WJMSC', 'timeFrame': '12 months', 'description': 'The efficacy of the intra-articular injection of WJMSC will be assessed by Magnetic Resonance Imaging (MRI).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['osteoarthrosis', 'Knee', 'Wharton Jelly'], 'conditions': ['Knee Osteoarthrosis']}, 'descriptionModule': {'briefSummary': 'Wharton Jelly derived Mesenchymal Stem Cells (WJMSC) will be injected in patients diagnosed with Knee osteoarthrosis', 'detailedDescription': 'Ten patients from both genders diagnosed with Knee osteoarthrosis, will be enrolled according to strict inclusion and exclusion criteria. These patients will be injected with Wharton Jelly derived Mesenchymal Stem Cells. Then, they are followed by clinical assessment, laboratory investigations as well as magnetic resonance imaging (MRI) of the injected knee.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '42 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Severe KOA stage III or IV by Laurance \\& Kellgren staging as judged by Posterioranterior (PA) Xray of the knee joint.\n* Willing to participate by signing the informed consent\n\nExclusion Criteria:\n\n1. Sublaxation beyond 20 degrees of the bones of the knee joint\n2. Oral anticoagulants or heparin therapy\n3. Heart failure or arrhythmia\n4. Body Mass Index \\> 35\n5. Uncontrolled Diabetes Mellitus.\n6. Evidence of Infectious Diseases.\n7. Active infection\n8. Malignancy\n9. Pregnancy\n10. Anemia less than 11g/dl or thrombocytopenia less than 100,000 or leucopenia less than 3000.\n11. Unreliable patients\n12. Non-resident in Jordan'}, 'identificationModule': {'nctId': 'NCT02963727', 'briefTitle': 'Use of Wharton Jelly Derived Mesenchymal Stem Cells for Knee Osteoarthrosis', 'organization': {'class': 'OTHER', 'fullName': 'University of Jordan'}, 'officialTitle': 'Knee Osteoarthrosis (KOA) in Jordanian Patients: a Phase I Dose-finding Study Using Wharton Jelly Derived Mesenchymal Stem Cells (WJMSC) for Advanced Stage III and IV KOA', 'orgStudyIdInfo': {'id': 'AlloKneeUJCTC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Wharton Jelly mesenchymal stem cell', 'description': 'Intra-articular Wharton Jelly derived mesenchymal stem cell injection will be given for each patient in 2 doses, 50 million of WJMSC in each dose', 'interventionNames': ['Biological: Wharton Jelly derived mesenchymal stem cell']}], 'interventions': [{'name': 'Wharton Jelly derived mesenchymal stem cell', 'type': 'BIOLOGICAL', 'description': 'Intra-articular Wharton Jelly derived mesenchymal stem cell injection.', 'armGroupLabels': ['Wharton Jelly mesenchymal stem cell']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11942', 'city': 'Amman', 'status': 'RECRUITING', 'country': 'Jordan', 'contacts': [{'name': 'Abdalla Awidi, MD', 'role': 'CONTACT', 'email': 'abdalla.awidi@gmail.com', 'phone': '0096265355000', 'phoneExt': '23960'}], 'facility': 'Cell Therapy Center', 'geoPoint': {'lat': 31.95522, 'lon': 35.94503}}], 'centralContacts': [{'name': 'Hanan Jafar, PhD', 'role': 'CONTACT', 'email': 'hanan.jafar@gmail.com', 'phone': '00962798871087'}], 'overallOfficials': [{'name': 'Abdallah Awidi, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cell Therapy Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hanan Jafar', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Researcher', 'investigatorFullName': 'Hanan Jafar', 'investigatorAffiliation': 'University of Jordan'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-05-09', 'type': 'RELEASE'}, {'date': '2024-01-25', 'type': 'RESET'}, {'date': '2025-01-26', 'type': 'RELEASE'}, {'date': '2025-02-14', 'type': 'RESET'}, {'date': '2025-04-07', 'type': 'RELEASE'}, {'date': '2025-04-24', 'type': 'RESET'}, {'date': '2025-04-27', 'type': 'RELEASE'}, {'date': '2025-05-13', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Hanan Jafar, Researcher, University of Jordan'}}}}