Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2026-01-03 @ 8:43 PM
Study NCT ID:
NCT03110666
Status:
COMPLETED
Last Update Posted:
2022-05-31
First Post:
2017-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment for Knee Osteoarthritis With Injections of BMC at the Bone-cartilage Interface. Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'autologous concentrated bone marrow aspirate'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-27', 'studyFirstSubmitDate': '2017-03-30', 'studyFirstSubmitQcDate': '2017-04-06', 'lastUpdatePostDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'improvement of the International Knee Documentation Committee (IKDC) subjective score', 'timeFrame': 'Time Frame: 1,3,6, 12, 24 months evaluation', 'description': '(International Knee Documentation Committee)'}], 'secondaryOutcomes': [{'measure': 'improvement of the Knee Injury and osteoarthritis Outcome Score (KOOS)', 'timeFrame': 'Time Frame: 1,3,6, 12, 24 months evaluation', 'description': '(Knee Injury and osteoarthritis Outcome Score)'}, {'measure': 'evaluation of WORMS score for MRI', 'timeFrame': 'Time Frame: 6, 12, 24 months evaluation', 'description': 'MRI score'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['knee osteoarthritis ,', 'bone marrow aspirate', 'injections'], 'conditions': ['Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'This pilot study will evaluate the clinica! and radiological results of a treatment for knee osteoarthritis with injections of autologous concentrated bone marrow aspirate at the bone-cartilage interface via percutaneous.', 'detailedDescription': 'This pilot study (N=30) patients will evaluate the clinica! and radiological results of a treatment for knee osteoarthritis with injections of bone marrow concentrate (BMC),obtained from the Bone Marrow Aspirate Concentration System (BioCUE) at the bone-cartilage interface via percutaneous injections. The PerFuse system will also be evaluated to determine if it can be used to deliver the BMC to the osseous sites. Follow-up is 1, 3, 6, 12, and 24 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age ranging from 40 to 75\n* Osteoarthritis of the medial or lateral compartment (2-3-4 grade according to the Kellgren-Lawrence score);\n* Failure after at least 6 months of conservative treatment (drug therapy with NSAIDs,hyaluronic acid,platelet-rich plasma and corticosteroids injections);\n* Signature of informed consent.\n\nExclusion Criteria:\n\n* Patients with trauma in the 6 months prior to the intervention;\n* Patients with malignancies;\n* Patients with rheumatic diseases;\n* Patients with diabetes;\n* Patients suffering from metabolic disorders of the thyroid;\n* Patients being abuse of alcohol, drugs or medications;\n* Body Mass Index\\> 35;'}, 'identificationModule': {'nctId': 'NCT03110666', 'acronym': 'IOC-target', 'briefTitle': 'Treatment for Knee Osteoarthritis With Injections of BMC at the Bone-cartilage Interface. Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Ortopedico Rizzoli'}, 'officialTitle': 'Treatment for Knee Osteoarthritis With Injections of Autologous Concentrated Bone Marrow Aspirate at the Bone-cartilage Interface Via Percutaneous. Pilot Study', 'orgStudyIdInfo': {'id': 'IOC-target'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Autologous concentrated bone marrow aspirate', 'description': 'autologous concentrated bone marrow aspirate obtained from the BioCUE Concentration System', 'interventionNames': ['Biological: Injection of autologous concentrated bone marrow aspirate']}], 'interventions': [{'name': 'Injection of autologous concentrated bone marrow aspirate', 'type': 'BIOLOGICAL', 'description': 'Percutaneous injections at the bone-cartilage interface (distal femur and proximal tibia)', 'armGroupLabels': ['Autologous concentrated bone marrow aspirate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40136', 'city': 'Bologna', 'country': 'Italy', 'facility': 'Rizzoli Orthopaedic Institute', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}], 'overallOfficials': [{'name': 'Elizaveta Kon, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Rizzoli Orthopedic Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Ortopedico Rizzoli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}