Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-25 @ 5:18 PM
Study NCT ID:
NCT06353503
Status:
RECRUITING
Last Update Posted:
2025-08-07
First Post:
2024-03-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bone Marrow Aspirate Concentrate for Anterior Cruciate Ligament Tear Treatment.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070598', 'term': 'Anterior Cruciate Ligament Injuries'}], 'ancestors': [{'id': 'D007718', 'term': 'Knee Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'single armed study open label'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-09-27', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-02', 'studyFirstSubmitDate': '2024-03-26', 'studyFirstSubmitQcDate': '2024-04-02', 'lastUpdatePostDateStruct': {'date': '2025-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional recovery by clinical assessments of the ACL and overall knee joint stability.', 'timeFrame': 'every 12 weeks till 6 months', 'description': 'lachman test'}], 'secondaryOutcomes': [{'measure': 'magnetic resonance imaging of the knee joint', 'timeFrame': '6 months from starting recruitment', 'description': 'to assess the degree of anterior cruciate ligament tear'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anterior Cruciate Ligament Tear']}, 'descriptionModule': {'briefSummary': 'A single armed multicenter study enrolling 20 patients using autologous bone marrow aspirate concentrate (which is done under local or general anesthesia to aspirate around 1-2 cc/kg body weight then concentration which is done by using centrifugation and special disposable kit) local injection of 4 cc per joint under ultrasonic guidance ,completely sterile field with local anesthesia.', 'detailedDescription': 'The anterior cruciate ligament (ACL) is key to the functional stability of the knee joint and is highly susceptible to injury, especially in athletes engaged in high-impact sports. Conventional treatment for partial tears may involve conservative management; however, complete tears often necessitate surgical reconstruction. In seeking alternative treatments, this study investigates the potential of bone marrow aspirate concentrate BMAC-a regenerative medicine approach-to promote healing and restore functionality to completely torn ACLs. The regenerative properties of BMAC, attributed to the presence of stem cells and growth factors, may facilitate ligament repair and regeneration. the team aim treating 1st and 2nd degree anterior cruciate ligament tear without retraction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1- Confirmed diagnosis of complete or partial ACL tear via clinical examination and imaging studies.\n\n2\\. Aged between 20 and 55 years, to encompass the typical age range of patients with sports-related ACL injuries.\n\nExclusion Criteria:\n\n1- Patients with a history of bleeding disorders, as this could complicate the aspiration and injection procedures.\n\n2\\. Individuals with a history of malignancy, due to the potential risks associated with growth factors present in BMAC.\n\n3\\. Critically ill patients or those with comorbidities'}, 'identificationModule': {'nctId': 'NCT06353503', 'briefTitle': 'Bone Marrow Aspirate Concentrate for Anterior Cruciate Ligament Tear Treatment.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Global Stem Cell Center, Baghdad'}, 'officialTitle': 'Using Autologous Bone Marrow Aspirate Concentrate to Treat Complete Anterior Cruciate Ligament Tear.', 'orgStudyIdInfo': {'id': 'KAZ'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'bone marrow injection', 'description': 'intra articular injection of autologous bone marrow aspirate concentrate 4cc in the injured knee under local anesthesia and ultrasound guide', 'interventionNames': ['Procedure: autologous bone marrow aspirate concentrate']}], 'interventions': [{'name': 'autologous bone marrow aspirate concentrate', 'type': 'PROCEDURE', 'description': 'local knee joint injection of autologous bone marrow', 'armGroupLabels': ['bone marrow injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '964', 'city': 'Baghdad', 'status': 'RECRUITING', 'country': 'Iraq', 'contacts': [{'name': 'thamer A alrubaie, MD', 'role': 'CONTACT', 'email': 'alzaitounhospital@gmail.com', 'phone': '+9647700009294'}], 'facility': 'Ministry of Health', 'geoPoint': {'lat': 33.34058, 'lon': 44.40088}}], 'centralContacts': [{'name': 'abdulmajeed A hammadi, MD', 'role': 'CONTACT', 'email': 'majeed51578@yahoo.co.uk', 'phone': '+9647902268105'}, {'name': 'khalil J kareem, MD', 'role': 'CONTACT', 'email': 'khaliljumakareem69@gmail.com', 'phone': '+9647803977072'}], 'overallOfficials': [{'name': 'abdulmajeed a hammadi, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'clinical stem cell studies'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'abdulmajeed hammadi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'GSCCBaghdad', 'investigatorFullName': 'abdulmajeed hammadi', 'investigatorAffiliation': 'Global Stem Cell Center, Baghdad'}}}}