Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2026-01-25 @ 3:12 AM
Study NCT ID:
NCT02037204
Status:
COMPLETED
Last Update Posted:
2019-01-02
First Post:
2014-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
IMPACT: Safety and Feasibility of a Single-stage Procedure for Focal Cartilage Lesions of the Knee.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005549', 'term': 'Foreign-Body Reaction'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D014095', 'term': 'Tooth, Impacted'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D005547', 'term': 'Foreign Bodies'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'd.saris@umcutrecht.nl', 'phone': '000000000000000000', 'title': 'Prof. Daniel Saris', 'organization': 'UMC Utrecht'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'All patients were monitored for the duration of 18 months after surgery, at fixed time points (at 7 days, 6 weeks and 3,6,12 and 18 months after surgery), for inflammation and signs of a foreign body response by an independent physician (rheumatologist) using standardized clinical measures, pain assessment by numeric rating scale for pain and blood analysis including serum C-reactive protein (CRP), erythrocyte sedimentation rate (ESR) and leukocyte count.', 'eventGroups': [{'id': 'EG000', 'title': 'Cartilage Repair Surgery', 'description': 'All 35 patients received a single-stage cartilage repair treatment using autologous chondrons and allogeneic MSCs in a fibrin glue carrier.', 'otherNumAtRisk': 35, 'otherNumAffected': 18, 'seriousNumAtRisk': 35, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Post surgery (joint swelling, pain)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 25, 'numAffected': 18}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Safety: Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cartilage Repair Surgery', 'description': 'Single-stage cartilage repair surgery in 35 patients, using autologous chondrons and allogeneic MSCs in a fibrin glue carrier.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '18 months', 'description': 'Adverse events rate', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients were monitored for the duration of the studie for inflammation and signs of a foreign body response by an independent physician using standardized clinical measures, pain assessment by numeric rating scale for pain and blood analysis including serum C-reactive protein, erythrocyte sedimentation rate and leukocyte count.'}, {'type': 'SECONDARY', 'title': 'Clinical Improvement, Knee Injury and Osteoarthritis Outcome Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cartilage Repair Surgery', 'description': 'To evaluate the clinical status of the patients treated with the IMPACT therapy, the included patients were asked to complete the Knee injury and Osteoarthritis Outcome Scoring (KOOS), The visual analog scale (VAS) for pain and the EuroQoL 5-Dimension Health Questionnaire (EQ5D) at baseline (before IMPACT therapy) and at 3, 6, and 12 months follow-up.'}], 'classes': [{'title': 'KOOS outcome baseline', 'categories': [{'measurements': [{'value': '57.9', 'spread': '16.1', 'groupId': 'OG000'}]}]}, {'title': 'KOOS outcome 3 months', 'categories': [{'measurements': [{'value': '76.6', 'spread': '11.1', 'groupId': 'OG000'}]}]}, {'title': 'KOOS outcome 18 months', 'categories': [{'measurements': [{'value': '85.4', 'spread': '13.3', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000'], 'groupDescription': 'A repeated-measures analysis of variance was used to test for differences in clinical outcome between baseline and 3, and 18 months after surgery.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'A repeated-measures analysis of variance was used to test for differences in clinical outcome between baseline and 3, and 18 months after surgery.'}], 'paramType': 'MEAN', 'timeFrame': '3 and 18 months', 'description': 'Clinical improvement as measured by patient reported outcome scores. The questionnaire has been developed to evaluate the symptoms and limitations for patients with osteoarthritis. The outcome of the KOOS-scale varies from 0-100, where 0 indicates the greatest possible problems and is the worst outcome and 100 indicates no problems.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Differences in clinical outcome between baseline and 3 and 12 months after surgery were tested by a repeated measures analysis of variance (ANOVA).'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Structural Repair', 'timeFrame': '12 months', 'description': 'To examine parameters of structural repair at one year after treatment using MRI and a second-look arthroscopy.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Health Care Use and Costs', 'timeFrame': '18 months', 'description': 'To assess the healthcare use and costs related to the procedure as well as the health-related work leave during the study period.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cartilage Repair Surgery', 'description': 'All 35 patients received a single-stage cartilage repair treatment using autologous chondrons and allogeneic MSCs in a fibrin glue carrier.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Patient recruitment started on February 1st 2013 and was completed in September 2014', 'preAssignmentDetails': 'Four patients were excluded based on MRI scans showing multiple cartilage defects and/ or osteochondral defects. Inclusion was continued until n = 35 was reached'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Cartilage Repair Surgery', 'description': 'Single-stage cartilage repair surgery using autologous chondrons and allogeneic MSCs in a fibrin glue carrier.\n\nCartilage repair surgery: Single-stage surgery, After debridement, the cartilage defect is filled with the fibrin glue carrier containing autologous chondrons and allogeneic MSCs'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '35', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33', 'spread': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Netherlands', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'First in man surgery: autologous chondrons are mixed with allogeneic MSCs and implanted in a fibrin glue carrier in a one-stage surgical procedure.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-25', 'studyFirstSubmitDate': '2014-01-13', 'resultsFirstSubmitDate': '2016-05-26', 'studyFirstSubmitQcDate': '2014-01-13', 'lastUpdatePostDateStruct': {'date': '2019-01-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-06-25', 'studyFirstPostDateStruct': {'date': '2014-01-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-01-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Structural Repair', 'timeFrame': '12 months', 'description': 'To examine parameters of structural repair at one year after treatment using MRI and a second-look arthroscopy.'}, {'measure': 'Health Care Use and Costs', 'timeFrame': '18 months', 'description': 'To assess the healthcare use and costs related to the procedure as well as the health-related work leave during the study period.'}], 'primaryOutcomes': [{'measure': 'Safety: Adverse Events', 'timeFrame': '18 months', 'description': 'Adverse events rate'}], 'secondaryOutcomes': [{'measure': 'Clinical Improvement, Knee Injury and Osteoarthritis Outcome Score', 'timeFrame': '3 and 18 months', 'description': 'Clinical improvement as measured by patient reported outcome scores. The questionnaire has been developed to evaluate the symptoms and limitations for patients with osteoarthritis. The outcome of the KOOS-scale varies from 0-100, where 0 indicates the greatest possible problems and is the worst outcome and 100 indicates no problems.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['IMPACT', 'Chondrons', 'Mesenchymal stem cells', 'Allogeneic MSCs', 'single-stage', 'Cartilage repair', 'Safety', 'Efficacy'], 'conditions': ['Foreign-Body Reaction', 'Inflammation', 'Effusion (L) Knee', 'Knee Pain Swelling']}, 'referencesModule': {'references': [{'pmid': '23583464', 'type': 'BACKGROUND', 'citation': 'Bekkers JE, Creemers LB, Tsuchida AI, van Rijen MH, Custers RJ, Dhert WJ, Saris DB. One-stage focal cartilage defect treatment with bone marrow mononuclear cells and chondrocytes leads to better macroscopic cartilage regeneration compared to microfracture in goats. Osteoarthritis Cartilage. 2013 Jul;21(7):950-6. doi: 10.1016/j.joca.2013.03.015. Epub 2013 Apr 9.'}, {'pmid': '23831891', 'type': 'BACKGROUND', 'citation': 'Bekkers JE, Tsuchida AI, van Rijen MH, Vonk LA, Dhert WJ, Creemers LB, Saris DB. Single-stage cell-based cartilage regeneration using a combination of chondrons and mesenchymal stromal cells: comparison with microfracture. Am J Sports Med. 2013 Sep;41(9):2158-66. doi: 10.1177/0363546513494181. Epub 2013 Jul 5.'}, {'pmid': '20213765', 'type': 'BACKGROUND', 'citation': "Vonk LA, Doulabi BZ, Huang C, Helder MN, Everts V, Bank RA. Preservation of the chondrocyte's pericellular matrix improves cell-induced cartilage formation. J Cell Biochem. 2010 May;110(1):260-71. doi: 10.1002/jcb.22533."}], 'seeAlsoLinks': [{'url': 'https://www.clinicaltrialsregister.eu/ctr-search/trial/2012-001570-29/NL', 'label': 'Trials Register of the European Union'}, {'url': 'https://www.youtube.com/watch?v=S3rIBjA03AA', 'label': 'IMPACT animation'}]}, 'descriptionModule': {'briefSummary': 'Articular cartilage defects in the knee have a poor intrinsic healing capacity and may lead to functional disability and osteoarthritis. Cartilage cell therapy using autologous chondrocyte implantation (ACI) has been established as the first advanced treatment therapy medicinal product. Although this technique has achieved good mid-term results, it is a costly and extensive two-stage procedure which is limited by the number of chondrocytes obtained by biopsy and the dedifferentiation resulting from the expansion phase. Therefore, there is a need for improvement. A new cartilage repair technique should aim at decreasing surgical trauma, lowering complexity, improving logistics and cost-effectiveness while retaining or improving clinical outcome. Direct contact between mesenchymal stromal cells (MSCs) and dedifferentiated articular chondrocytes in vitro showed improvement of the chondrogenic phenotype of dedifferentiated articular chondrocytes. In addition, preserving the pericellular matrix of chondrocytes improves cartilage formation. These chondrons (chondrocytes with their pericellular matrix) have shown improved cartilage formation when combined with allogeneic MSCs in extensive preclinical studies. The cells are mixed with fibrin cell carrier and applied to the cartilage lesion within one surgical procedure. This will reduce patient morbidity and improve patient care through immediate transplantation of a potent cell-based cartilage product. This is a phase I/II prospective monocenter study to evaluate the safety and feasibility of the IMPACT for treatment of focal articular cartilage lesions of the knee.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>18 and \\<45 years old\n* Symptomatic isolated full-thickness articular cartilage lesion on the femoral condyle or trochlea.\n* Size 2 - 8 cm2\n* Intact anterior cruciate ligament\n\nExclusion Criteria:\n\n* (History of) osteoarthritis, defined as Kellgren-Lawrence grade \\>3 as determined from appropriate X-ray.\n* Concomitant inflammatory disease that affects the joint (rheumatoid arthritis, metabolic bone disease, psoriasis, gout, symptomatic chondrocalcinosis)\n* (History of) Septic arthritis.\n* Malalignment requiring an osteotomy.\n* (History of) total menisectomy in the target knee joint.\n* Any surgery in the knee joint 6 months prior to study inclusion.\n* Risk groups for MRI scanning due to the magnetic field like patients with pacemakers, nerve stimulators, metal particles, stents, clips or implants, (possible) pregnancy or breast feeding.\n* Patients with severe anxiety for MRI scans and/or needles'}, 'identificationModule': {'nctId': 'NCT02037204', 'acronym': 'IMPACT', 'briefTitle': 'IMPACT: Safety and Feasibility of a Single-stage Procedure for Focal Cartilage Lesions of the Knee.', 'organization': {'class': 'OTHER', 'fullName': 'UMC Utrecht'}, 'officialTitle': 'Instant MSC Product Accompanying Autologous Chondron Transplantation (IMPACT): Safety and Feasibility of a Single-stage Procedure for Focal Cartilage Lesions of the Knee.', 'orgStudyIdInfo': {'id': 'IMPACT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cartilage repair surgery', 'description': 'Single-stage cartilage repair surgery using autologous chondrons (10-20%) and allogeneic MSCs (80-90%) in a fibrin glue carrier with a dosage of two million cells/ cm2 applied once during a surgical procedure.', 'interventionNames': ['Other: Cartilage repair surgery']}], 'interventions': [{'name': 'Cartilage repair surgery', 'type': 'OTHER', 'otherNames': ['Single-stage', 'Cartilage repair', 'IMPACT'], 'description': 'Single-stage surgery, After debridement, the cartilage defect is filled with the fibrin glue carrier containing autologous chondrons and allogeneic MSCs', 'armGroupLabels': ['Cartilage repair surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3508GA', 'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'University Medical Center Utrecht', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}], 'overallOfficials': [{'name': 'Tommy S. de Windt, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'UMC Utrecht'}, {'name': 'Daniel B.F. Saris, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UMC Utrecht'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UMC Utrecht', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD, Orthopaedic surgeon', 'investigatorFullName': 'D.B.F. Saris', 'investigatorAffiliation': 'UMC Utrecht'}}}}