Ignite Creation Date:
2025-12-24 @ 5:57 PM
Ignite Modification Date:
2026-02-11 @ 12:34 AM
Study NCT ID:
NCT02123368
Status:
COMPLETED
Last Update Posted:
2017-10-24
First Post:
2013-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Knee Osteoarthritis by Intra-articular Injection of Bone Marrow Mesenchymal Stem Cells
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006820', 'term': 'Hyaluronic Acid'}], 'ancestors': [{'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-23', 'studyFirstSubmitDate': '2013-11-12', 'studyFirstSubmitQcDate': '2014-04-23', 'lastUpdatePostDateStruct': {'date': '2017-10-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-04-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Baseline Visual analogue scale (VAS)', 'timeFrame': 'prior to the initial dose on day 1', 'description': 'Baseline Visual analogue scale (VAS)'}, {'measure': 'Baseline value of knee injury and osteoarthritis outcome score (Koos).', 'timeFrame': 'Prior to the intervention on day 1', 'description': 'Prior to the intervention on day 1 value of knee injury and osteoarthritis outcome score (Koos).'}, {'measure': 'Baseline Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC).', 'timeFrame': 'Prior to the intervention on day 1', 'description': 'Prior to the intervention on day 1 Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC).'}, {'measure': 'Baseline SF-36 value', 'timeFrame': 'Prior to the intervention on day 1', 'description': 'Prior to the intervention on day 1 SF-36 value'}, {'measure': 'Baseline euroquol 5D value', 'timeFrame': 'Prior to the intervention on day 1', 'description': 'Pretreatment euroquol 5D value'}, {'measure': 'Baseline Lequesne index', 'timeFrame': 'Prior to the intervention on day 1', 'description': 'Prior to the intervention on day 1 Lequesne index'}, {'measure': 'Baseline femorotibial distance', 'timeFrame': 'Prior to the intervention', 'description': 'Prior to the intervention femoritibial distance on rosenberg x-ray view'}, {'measure': 'Number of Participants with Serious and Non-Serious Adverse Events Number of Participants with Serious and Non-Serious Adverse Events Number of Participants with Serious and Non-Serious Adverse Events', 'timeFrame': 'Follow up', 'description': 'During the follow up'}, {'measure': 'Visual analogue scale (VAS) at on month', 'timeFrame': '1 month', 'description': 'Visual analogue scale (VAS) at on month'}, {'measure': 'Visual analogue scale (VAS) at 3 months', 'timeFrame': '3 months', 'description': 'Visual analogue scale (VAS) at 3 months'}, {'measure': 'Visual analogue scale (VAS) at 6 months', 'timeFrame': '6 months', 'description': 'Visual analogue scale (VAS) at 6 months'}, {'measure': 'Visual analogue scale (VAS) at 12 months', 'timeFrame': '12 months', 'description': 'Visual analogue scale (VAS) at 12 months'}, {'measure': 'Value of knee injury and osteoarthritis outcome score (Koos) at 1 month', 'timeFrame': '1 month', 'description': 'Value of knee injury and osteoarthritis outcome score (Koos) at 1 month'}, {'measure': 'Value of knee injury and osteoarthritis outcome score (Koos) at 3 month', 'timeFrame': '3 Months', 'description': 'Value of knee injury and osteoarthritis outcome score (Koos) at 3 month'}, {'measure': 'Value of knee injury and osteoarthritis outcome score (Koos) at 6 month', 'timeFrame': '6 months', 'description': 'Value of knee injury and osteoarthritis outcome score (Koos) at 6 month'}, {'measure': 'Value of knee injury and osteoarthritis outcome score (Koos) at 12 months', 'timeFrame': '12 months', 'description': 'Value of knee injury and osteoarthritis outcome score (Koos) at 12 months'}, {'measure': 'Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC) at 1 month', 'timeFrame': '1 month', 'description': 'Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC) at 1 month'}, {'measure': 'Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC) at 3 month', 'timeFrame': '3 months', 'description': 'Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC) at 1 month'}, {'measure': 'Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC) at 6 month', 'timeFrame': '6 months', 'description': 'Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC) at 6 month'}, {'measure': 'Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC) at 12 months', 'timeFrame': '12 months', 'description': 'Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC) at 12 months'}, {'measure': 'SF-36 value at 1 month', 'timeFrame': '1 month', 'description': 'SF-36 value'}, {'measure': 'SF 36 value at 3 months', 'timeFrame': '3 months', 'description': 'SF 36 value at 3 months'}, {'measure': 'SF 36 value at 6 months', 'timeFrame': '6 months', 'description': 'SF 36 value at 6 months'}, {'measure': 'SF 36 value at 12 months', 'timeFrame': '12 months', 'description': 'SF 36 value at 12 months'}, {'measure': 'Euroquol 5D value at 1 month', 'timeFrame': '1 MOnth', 'description': 'Euroquol 5D value at 1 month'}, {'measure': 'Euroquol 5D value at 3 months', 'timeFrame': '3 months', 'description': 'Euroquol 5D value at 3 months'}, {'measure': 'Euroquol 5D value at 6 months', 'timeFrame': '6 months', 'description': 'Euroquol 5D value at 6 months'}, {'measure': 'Euroquol 5D value at 12 months', 'timeFrame': '12 months', 'description': 'Euroquol 5D value at 12 months'}, {'measure': 'Lequesne index at 1 month', 'timeFrame': '1 month', 'description': 'Lequesne index at 1 month'}, {'measure': 'Lequesne index at 3 months', 'timeFrame': '3 months', 'description': 'Lequesne index at 3 months'}, {'measure': 'Lequesne index at 6 months', 'timeFrame': '6 months', 'description': 'Lequesne index at 6 months'}, {'measure': 'Lequesne index at 12 months', 'timeFrame': '12 months', 'description': 'Lequesne index at 12 months'}, {'measure': 'Femorotibial distance at 6 months', 'timeFrame': '6 months', 'description': 'Femorotibial distance at 6 months'}, {'measure': 'Femorotibial distance at 12 months', 'timeFrame': '12 months', 'description': 'Femorotibial distance at 12 months'}, {'measure': 'Baseline MRI WORMS protocol', 'timeFrame': 'Prior to the intervention', 'description': 'Prior to the intervention MRI WORMS protocol'}, {'measure': 'MRI WORMS protocol score at 6 months', 'timeFrame': '6 months', 'description': 'MRI WORMS protocol score at 6 months'}, {'measure': 'MRI WORMS protocol score at 12 months', 'timeFrame': '12 months', 'description': 'MRI WORMS protocol score at 12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Osteoarthritis', 'Mesenchimal stem cell', 'Knee'], 'conditions': ['Osteoarthritis']}, 'referencesModule': {'references': [{'pmid': '34895259', 'type': 'DERIVED', 'citation': 'Lamo-Espinosa JM, Prosper F, Blanco JF, Sanchez-Guijo F, Alberca M, Garcia V, Gonzalez-Vallinas M, Garcia-Sancho J. Long-term efficacy of autologous bone marrow mesenchymal stromal cells for treatment of knee osteoarthritis. J Transl Med. 2021 Dec 11;19(1):506. doi: 10.1186/s12967-021-03160-2.'}, {'pmid': '30064455', 'type': 'DERIVED', 'citation': 'Lamo-Espinosa JM, Mora G, Blanco JF, Granero-Molto F, Nunez-Cordoba JM, Lopez-Elio S, Andreu E, Sanchez-Guijo F, Aquerreta JD, Bondia JM, Valenti-Azcarate A, Del Consuelo Del Canizo M, Villaron EM, Valenti-Nin JR, Prosper F. Intra-articular injection of two different doses of autologous bone marrow mesenchymal stem cells versus hyaluronic acid in the treatment of knee osteoarthritis: long-term follow up of a multicenter randomized controlled clinical trial (phase I/II). J Transl Med. 2018 Jul 31;16(1):213. doi: 10.1186/s12967-018-1591-7.'}, {'pmid': '27565858', 'type': 'DERIVED', 'citation': 'Lamo-Espinosa JM, Mora G, Blanco JF, Granero-Molto F, Nunez-Cordoba JM, Sanchez-Echenique C, Bondia JM, Aquerreta JD, Andreu EJ, Ornilla E, Villaron EM, Valenti-Azcarate A, Sanchez-Guijo F, Del Canizo MC, Valenti-Nin JR, Prosper F. Intra-articular injection of two different doses of autologous bone marrow mesenchymal stem cells versus hyaluronic acid in the treatment of knee osteoarthritis: multicenter randomized controlled clinical trial (phase I/II). J Transl Med. 2016 Aug 26;14(1):246. doi: 10.1186/s12967-016-0998-2.'}], 'seeAlsoLinks': [{'url': 'http://www.cun.es/actualidad/noticias/celulas-madre-osea-artrosis-rodilla', 'label': 'University clinic of navarre trial information'}]}, 'descriptionModule': {'briefSummary': 'Purpose: To determine the safety, feasibility and effectiveness (clinical and radiological) of intra-articular administration of autologous mesenchymal stem cells (MSCs) in patients with knee osteoarthritis.\n\nPatients and methods\n\nClinical trial phase I- II, randomized , multicenter , with three treatment arms and 10 patients for each group. The investigators compare the intraarticular injection of hialuronic acid against the administration of two different doses of mesenchymal stem cells with hialuronic acid according to the following scheme:\n\n1. Group A: intra-articular injection of hyaluronic acid (Hyalone®). Single dose.\n2. Group B: Low Dosage of MSCs . Intra-articular injection of 10 million autologous mesenchymal progenitor stem cells cultured ex - vivo (cell suspension sterile small volume (5-10 ml ) in a vehicle suitable for intraarticular injection ) followed by an intraarticular injection Hiaurónico Acid ( Hyalone®).\n3. Group C : High dose of MSCs. Intra-articular injection of 100 million autologous mesenchymal progenitor stem cells cultured ex - vivo ( cell suspension sterile small volume (5-10 ml ) in a vehicle suitable for intraarticular injection ) followed by an intraarticular injection Hiaurónico Acid (Hyalone®).\n\nThe primary endpoint is safety and feasibility. The investigators registered the occurrence of complications and / or adverse effects during the study.\n\nIn addition the investigators assess the response to intra-articular infusion of CMM analyzing the following parameters:\n\n* Clinical assessment of pain and function (Baseline, 1, 3, 6 and 12 months since treatment): VAS , WOMAC , KOOS , EuroQol, SF-16, Lequesne , WOMAC , KOOS.\n* Radiographic (baseline, 6 and 12 months since treatment): Femorotibial space.\n* Radiographic using MRI (baseline, 6 and 12 months since treatment): by assessing the number location of the lesions , cartilage thickness , signal intensity , subchondral bone alteration , volume and WORMS and dGEMRIC protocols.', 'detailedDescription': 'Purpose: To determine the safety, feasibility and effectiveness (clinical and radiological) of intra-articular administration of autologous mesenchymal stem cells (MSCs) in patients with knee osteoarthritis.\n\nPatients and methods\n\nClinical trial phase I- II, randomized , multicenter , with three treatment arms and 10 patients for each group. The investigators compare the intraarticular injection of hialuronic acid against the administration of two different doses of mesenchymal stem cells with hialuronic acid according to the following scheme:\n\n1. Group A: intra-articular injection of hyaluronic acid (Hyalone®). Single dose.\n2. Group B: Low Dosage of MSCs . Intra-articular injection of 10 million autologous mesenchymal progenitor stem cells cultured ex - vivo (cell suspension sterile small volume (5-10 ml ) in a vehicle suitable for intraarticular injection ) followed by an intraarticular injection Hiaurónico Acid ( Hyalone®).\n3. Group C : High dose of MSCs. Intra-articular injection of 100 million autologous mesenchymal progenitor stem cells cultured ex - vivo ( cell suspension sterile small volume (5-10 ml ) in a vehicle suitable for intraarticular injection ) followed by an intraarticular injection Hiaurónico Acid (Hyalone®).\n\nThe autologous mesenchymal stem cells are obtained from the iliac crest and cultured ex vivo under local anesthesia and sedation.\n\nThe primary endpoint is safety and feasibility. The investigators registered the occurrence of complications and / or adverse effects during the study.\n\nIn addition the investigators assess the response to intra-articular infusion of CMM analyzing the following parameters:\n\n* Clinical assessment of pain and function (Baseline, 1, 3, 6 and 12 months since treatment): VAS , WOMAC , KOOS , EuroQol, SF-16, Lequesne , WOMAC , KOOS.\n* Radiographic (baseline, 6 and 12 months since treatment): Femorotibial space.\n* Radiographic using MRI (baseline, 6 and 12 months since treatment): by assessing the number location of the lesions , cartilage thickness , signal intensity , subchondral bone alteration , volume and WORMS and dGEMRIC protocols.\n\nAll patients met the following inclusion and exclusion criteria:\n\nInclusion Criteria:\n\n* Males and females between 50 and 80 year old.\n* Diagnosis of knee OA according to the criteria of osteoarthritis of the ACR (American College of Rheumatology).\n* Joint pain equal or greater than 2.5 points on the visual analogue scale (VAS).\n* Radiological Classification: Kellgren-Lawrence scale greater or equal to 2.\n* Body mass index between 20 and 35 kg/m2.\n* Ability to follow during the study period.\n\nExclusion Criteria:\n\n* Bilateral Osteoarthritis of the Knee requiring treatment in both knees.\n* Previous diagnosis of polyarticular disease.\n* Severe mechanical deformation.\n* Arthroscopy during the previous 6 months.\n* Intraarticular infiltration of hyaluronic acid in the last 6 months.\n* Systemic autoimmune rheumatic disease.\n* Poorly controlled diabetes mellitus.\n* Blood dyscrasias.\n* Immunosuppressive or anticoagulant treatments.\n* Treatment with corticosteroids in the 3 months prior to inclusion in the study.\n* NSAID therapy within 15 days prior to inclusion in the study.\n* Patients with a history of allergy to penicillin or streptomycin.\n* Allergy to hyaluronic acid or poultry proteins.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females between 50 and 80 year old.\n* Diagnosis of knee OA according to the criteria of osteoarthritis of the ACR (American College of Rheumatology).\n* Joint pain equal or greater than 2.5 points on the visual analogue scale (VAS).\n* Radiological Classification: Kellgren-Lawrence scale greater or equal to 2.\n* Body mass index between 20 and 35 kg/m2.\n* Ability to follow during the study period.\n\nExclusion Criteria:\n\n* Bilateral Osteoarthritis of the Knee requiring treatment in both knees.\n* Previous diagnosis of polyarticular disease.\n* Severe mechanical deformation.\n* Arthroscopy during the previous 6 months.\n* Intraarticular infiltration of hyaluronic acid in the last 6 months.\n* Systemic autoimmune rheumatic disease.\n* Poorly controlled diabetes mellitus.\n* Blood dyscrasias.\n* Immunosuppressive or anticoagulant treatments.\n* Treatment with corticosteroids in the 3 months prior to inclusion in the study.\n* NSAID therapy within 15 days prior to inclusion in the study.\n* Patients with a history of allergy to penicillin or streptomycin.\n* Allergy to hyaluronic acid or poultry proteins.'}, 'identificationModule': {'nctId': 'NCT02123368', 'briefTitle': 'Treatment of Knee Osteoarthritis by Intra-articular Injection of Bone Marrow Mesenchymal Stem Cells', 'organization': {'class': 'OTHER', 'fullName': 'Clinica Universidad de Navarra, Universidad de Navarra'}, 'officialTitle': 'Treatment of Osteoarthritis by Intra-articular Injection of Bone Marrow Mesenchymal Stem Cells', 'orgStudyIdInfo': {'id': 'CMM/ART'}, 'secondaryIdInfos': [{'id': '2009-017624-72', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Hialuronic acid', 'description': 'Single intraarticular injection of Hyaluronic acid (Hyal One)', 'interventionNames': ['Drug: Hyaluronic acid']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Hyaluronic acid and MSC 10', 'description': 'Single intraarticular injection of Hyaluronic acid (Hyal One) 10 million Bone marrow mesenchimal stem cells', 'interventionNames': ['Drug: Hyaluronic acid', 'Biological: 10 million Bone marrow mesenchimal stem cells']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Hyaluronic acid AND MSC 100', 'description': 'Single intraarticular injection of Hyaluronic acid (Hyal One) 100 million Bone marrow mesenchimal stem cells', 'interventionNames': ['Drug: Hyaluronic acid', 'Biological: 100 million Bone marrow mesenchimal stem cells']}], 'interventions': [{'name': 'Hyaluronic acid', 'type': 'DRUG', 'otherNames': ['HyalOne'], 'description': 'Single intraarticular injection of Hyaluronic acid (Hyal One)', 'armGroupLabels': ['Hialuronic acid', 'Hyaluronic acid AND MSC 100', 'Hyaluronic acid and MSC 10']}, {'name': '10 million Bone marrow mesenchimal stem cells', 'type': 'BIOLOGICAL', 'description': '10 million of Bone marrow mesenchimal stem cells', 'armGroupLabels': ['Hyaluronic acid and MSC 10']}, {'name': '100 million Bone marrow mesenchimal stem cells', 'type': 'BIOLOGICAL', 'description': '100 million of Bone marrow mesenchimal stem cells', 'armGroupLabels': ['Hyaluronic acid AND MSC 100']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37007', 'city': 'Salamanca', 'state': 'Castille and León', 'country': 'Spain', 'facility': 'Traumatology department. Complejo Hospitalario de Salamanca', 'geoPoint': {'lat': 40.96882, 'lon': -5.66388}}, {'zip': '31008', 'city': 'Pamplona', 'state': 'Navarre', 'country': 'Spain', 'facility': 'Orthopaedic and traumatology department. Clínica Universidad de Navarra', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}], 'overallOfficials': [{'name': 'José Lamo-Espinosa, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinica Universidad de Navarra'}, {'name': 'Felipe Prosper, MD PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Clinica Universidad de Navarra'}, {'name': 'Juan Blanco, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Salamanca'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinica Universidad de Navarra, Universidad de Navarra', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}