Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2025-12-31 @ 7:20 PM
Study NCT ID:
NCT06937528
Status:
RECRUITING
Last Update Posted:
2025-04-22
First Post:
2024-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Extracellular Vesicles (EV) for Knee Osteoarthrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-13', 'studyFirstSubmitDate': '2024-02-27', 'studyFirstSubmitQcDate': '2025-04-13', 'lastUpdatePostDateStruct': {'date': '2025-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety', 'timeFrame': 'follow-up duration is 12 months', 'description': 'Measuring and evaluating the Safety and Tolerability of the intra-articular injection of extracellular vesicles:\n\nComplete Blood Count (CBC):\n\nHemoglobin (Hb) Hematocrit (Hct) White blood cells (WBCs) Platelets (PLTs) Red blood cell indices (MCV, MCH, MCHC) A. Liver Function Tests (LFTs) Alanine aminotransferase (ALT) Asparate aminotransferase (AST) Alkaline phosphatase (ALP) Gamma-glutamyl transferase (GGT) Total bilirubin (TBIL), Direct \\& Indirect bilirubin Albumin and total protein B. Kidney Function Tests Blood Urea Nitrogen (BUN) Serum Creatinine Uric Acid Estimated Glomerular Filtration Rate (eGFR) C. Electrolyte Panel Sodium (Na⁺) Potassium (K⁺) Calcium (Ca²⁺) Magnesium (Mg²⁺) Chloride (Cl-) Bicarbonate (HCO₃-) D. Glucose \\& Lipid Profile Fasting blood glucose (FBG) Total cholesterol, HDL, LDL, Triglycerides Prothrombin Time (PT) Activated Partial Thromboplastin Time (aPTT) INR (International Normalized Ratio)'}], 'secondaryOutcomes': [{'measure': 'Efficacy', 'timeFrame': 'follow-up duration is 12 months', 'description': 'Measuring and evaluating the efficacy of the Intra Articular Injection of extracellular vesicles measure pain score by questionnaire: KOOS (Knee Injury and Osteoarthritis Outcome Score) Extension of WOMAC, more detailed\n\nDomains:\n\nPain\n\nSymptoms\n\nActivities of daily living (ADL)\n\nSport and recreation\n\nQuality of life (QoL)\n\nScoring: 0-100 scale (0 = extreme symptoms, 100 = no symptoms)\n\nUse: Young and active OA patients, post-surgery (e.g., ACL, TKA)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['osteoarthrosis', 'Knee', 'Extracellular vesicles'], 'conditions': ['Knee Osteoarthrosis']}, 'descriptionModule': {'briefSummary': 'Extracellular vesicles (EV) will be injected in patients diagnosed with Knee osteoarthrosis', 'detailedDescription': '50 patients from both genders diagnosed with Knee osteoarthrosis, will be enrolled according to strict inclusion and exclusion criteria. These patients will be injected with Extracellular vesicles (EV). 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\n* Sublaxation beyond 20 degrees of the bones of the knee joint\n* Oral anticoagulants or heparin therapy\n* Heart failure or arrhythmia\n* Body Mass Index \\> 35\n* Uncontrolled Diabetes Mellitus.\n* Evidence of Infectious Diseases.\n* Active infection\n* Malignancy\n* Pregnancy\n* Anemia less than 11g/dl or thrombocytopenia less than 100,000 or leucopenia less than 3000.\n* Unreliable patients\n* Non-resident in Jordan'}, 'identificationModule': {'nctId': 'NCT06937528', 'briefTitle': 'Use of Extracellular Vesicles (EV) for Knee Osteoarthrosis', 'organization': {'class': 'OTHER', 'fullName': 'University of Jordan'}, 'officialTitle': 'Knee Osteoarthrosis (KOA) in Jordanian Patients: a Phase I Dose-finding Study Using Extracellular Vesicles (EV) for Advanced Stage III and IV KOA', 'orgStudyIdInfo': {'id': 'EVKneeUJCTC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Extracellular vesicles (EV)', 'description': 'Intra-articular Extracellular vesicles injection will be given to each patient in 2 doses', 'interventionNames': ['Biological: Extracellular vesicles']}], 'interventions': [{'name': 'Extracellular vesicles', 'type': 'BIOLOGICAL', 'otherNames': ['EV'], 'description': 'Intra-articular extravascular vesicles injection.', 'armGroupLabels': ['Extracellular vesicles (EV)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00962', 'city': 'Amman', 'status': 'RECRUITING', 'country': 'Jordan', 'contacts': [{'name': 'Hanan Jafar, PhD', 'role': 'CONTACT', 'email': 'hanan.jafar@gmail.com', 'phone': '00962798871087'}, {'name': 'Abdallah 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'}, {'name': 'Abdallah Awidi, MD', 'role': 'CONTACT', 'email': 'abdalla.awidi@gmail.com', 'phone': '0096265355000', 'phoneExt': '23960'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Jordan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Abdalla Awidi Abbadi, MD', 'class': 'UNKNOWN'}, {'name': 'The University of Jordan', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Hanan Jafar', 'investigatorAffiliation': 'University of Jordan'}}}}