Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
Study NCT ID:
NCT01586312
Status:
COMPLETED
Last Update Posted:
2015-10-16
First Post:
2012-04-23
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Treatment of Knee Osteoarthritis With Allogenic Mesenchymal Stem Cells
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint 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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jgsancho@ibgm.uva.es', 'phone': '34 983 423 084', 'title': 'Professor Javier Garcia-Sancho', 'organization': 'Instituto de Biología y Genética Molecular (IBGM)'}, 'certainAgreement': {'otherDetails': 'The only disclosure restriction on the PI is that the sponsor must review results communications prior to public release.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '1 year', 'description': 'All patients completed the study successfully. The mean duration of the patients in the study was 12.4 (± 0.6) months, 12.5 (± 0.8) months in the MSV group and 12.4 (± 0.3) months in the hyaluronic acid group.', 'eventGroups': [{'id': 'EG000', 'title': 'Allogenic Mesenchymal Stromal Cells', 'description': 'Mesenchymal stem cells (MSC) prepared from bone marrow from healthy donor expanded ex vivo for 3-4 weeks. Intraarticular injection of 40 millions MSC.\n\nInjection of Mesenchymal Stromal Cells: Mesenchymal stem cells prepared from bone marrow of healthy donors and expanded for 3-4 weeks according to our procedure described in PEI Num. 10-134, authorized by the Spanish Medicine Agency', 'otherNumAtRisk': 15, 'otherNumAffected': 14, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Hyaluronic Acid (Durolane)', 'description': 'Intraarticular injection of hyaluronic acid (60 mg)\n\nHyaluronic Acid: Intra-articular injection of 60 mg of hyaluronic acid (Durolane) in a single injection (3 ml)', 'otherNumAtRisk': 15, 'otherNumAffected': 13, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Artralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 9, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Joint Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Nasofaringitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Rinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Neoplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Dental implant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Allergic dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Amenorrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Testicular pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Premature menopause', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Menorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Amnesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 12, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Drowsiness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Dental pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Leak', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Artralgia/Artritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Arthralgia/Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Corneal erosion / Blepharitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Nervousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events as a Measure of Safety and Tolerability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Allogenic Mesenchymal Stromal Cells', 'description': 'Mesenchymal stem cells (MSC) prepared from bone marrow from healthy donor expanded ex vivo for 3-4 weeks. Intraarticular injection of 40 millions MSC.\n\nInjection of Mesenchymal Stromal Cells: Mesenchymal stem cells prepared from bone marrow of healthy donors and expanded for 3-4 weeks according to our procedure described in PEI Num. 10-134, authorized by the Spanish Medicine Agency'}, {'id': 'OG001', 'title': 'Hyaluronic Acid (Durolane)', 'description': 'Intraarticular injection of hyaluronic acid (60 mg)\n\nHyaluronic Acid: Intra-articular injection of 60 mg of hyaluronic acid (Durolane) in a single injection (3 ml)'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to one year', 'description': 'Adverse events reported. Clinical review and questionaires for pain, disability and quality of life at 0, 3, 6 and 12 months', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy evaluable patients (EEP): A patient has been considered evaluable whenever it has undergone the specified interventions (injection of hyaluronic acid or allogeneic MSC).\n\nand\n\nSafety population (SP): The population that includes all evaluable patients who have undergone one of the two study treatments.'}, {'type': 'SECONDARY', 'title': 'Pain and Disability Evolution (WOMAC, Visual Analogue Scale, Lequesne Index and SF-12 Scores)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Allogenic Mesenchymal Stromal Cells', 'description': 'Mesenchymal stem cells (MSC) prepared from bone marrow from healthy donor expanded ex vivo for 3-4 weeks. Intraarticular injection of 40 millions MSC.\n\nInjection of Mesenchymal Stromal Cells: Mesenchymal stem cells prepared from bone marrow of healthy donors and expanded for 3-4 weeks according to our procedure described in PEI Num. 10-134, authorized by the Spanish Medicine Agency'}, {'id': 'OG001', 'title': 'Hyaluronic Acid (Durolane)', 'description': 'Intraarticular injection of hyaluronic acid (60 mg)\n\nHyaluronic Acid: Intra-articular injection of 60 mg of hyaluronic acid (Durolane) in a single injection (3 ml)'}], 'classes': [{'title': 'WOMAC11_Changes from Basal - General 3 months', 'categories': [{'measurements': [{'value': '-8.48', 'spread': '22.6', 'groupId': 'OG000'}, {'value': '-4.52', 'spread': '17.4', 'groupId': 'OG001'}]}]}, {'title': 'WOMAC11_Changes from Basal - General 6 months', 'categories': [{'measurements': [{'value': '-13.03', 'spread': '18.2', 'groupId': 'OG000'}, {'value': '-5.47', 'spread': '15.9', 'groupId': 'OG001'}]}]}, {'title': 'WOMAC11_Changes from Basal - General 12 months', 'categories': [{'measurements': [{'value': '-13.47', 'spread': '22.8', 'groupId': 'OG000'}, {'value': '-4.10', 'spread': '18.4', 'groupId': 'OG001'}]}]}, {'title': 'WOMAC11_Changes from Basal - Dificulty 3 months', 'categories': [{'measurements': [{'value': '-8.51', 'spread': '22.8', 'groupId': 'OG000'}, {'value': '-6.46', 'spread': '18.7', 'groupId': 'OG001'}]}]}, {'title': 'WOMAC11_Changes from Basal - Dificulty 6 months', 'categories': [{'measurements': [{'value': '-14.53', 'spread': '19.8', 'groupId': 'OG000'}, {'value': '-6.97', 'spread': '20.5', 'groupId': 'OG001'}]}]}, {'title': 'WOMAC11_Changes from Basal - Dificulty 12 months', 'categories': [{'measurements': [{'value': '-12.59', 'spread': '23.1', 'groupId': 'OG000'}, {'value': '-4.26', 'spread': '21.3', 'groupId': 'OG001'}]}]}, {'title': 'WOMAC11_Changes from Basal - Stiffness 3 months', 'categories': [{'measurements': [{'value': '-4.77', 'spread': '30.5', 'groupId': 'OG000'}, {'value': '-1.93', 'spread': '25.2', 'groupId': 'OG001'}]}]}, {'title': 'WOMAC11_Changes from Basal - Stiffness 6 months', 'categories': [{'measurements': [{'value': '-3.17', 'spread': '23.8', 'groupId': 'OG000'}, {'value': '-2.87', 'spread': '23.6', 'groupId': 'OG001'}]}]}, {'title': 'WOMAC11_Changes from Basal - Stiffness 12 months', 'categories': [{'measurements': [{'value': '-10.67', 'spread': '31.1', 'groupId': 'OG000'}, {'value': '-4.50', 'spread': '29.5', 'groupId': 'OG001'}]}]}, {'title': 'WOMAC11_Changes from Basal - Pain 3 months', 'categories': [{'measurements': [{'value': '-10.01', 'spread': '23.7', 'groupId': 'OG000'}, {'value': '-4.27', 'spread': '17.2', 'groupId': 'OG001'}]}]}, {'title': 'WOMAC11_Changes from Basal - Pain 6 months', 'categories': [{'measurements': [{'value': '-13.02', 'spread': '19.0', 'groupId': 'OG000'}, {'value': '-5.97', 'spread': '12.1', 'groupId': 'OG001'}]}]}, {'title': 'WOMAC11_Changes from Basal - Pain 12 months', 'categories': [{'measurements': [{'value': '-16.30', 'spread': '23', 'groupId': 'OG000'}, {'value': '-6.36', 'spread': '15.8', 'groupId': 'OG001'}]}]}, {'title': 'SF-12_Changes from Basal - General Health 3 months', 'categories': [{'measurements': [{'value': '0.12', 'spread': '22.5', 'groupId': 'OG000'}, {'value': '0.39', 'spread': '16.2', 'groupId': 'OG001'}]}]}, {'title': 'SF-12_Changes from Basal - General Health 6 months', 'categories': [{'measurements': [{'value': '10.64', 'spread': '22.8', 'groupId': 'OG000'}, {'value': '2.11', 'spread': '21.2', 'groupId': 'OG001'}]}]}, {'title': 'SF-12_Changes from Basal - General Health 12 month', 'categories': [{'measurements': [{'value': '5.24', 'spread': '27.9', 'groupId': 'OG000'}, {'value': '2.51', 'spread': '21.1', 'groupId': 'OG001'}]}]}, {'title': 'SF-12_Changes from Basal - Physical function 3 m', 'categories': [{'measurements': [{'value': '10.00', 'spread': '36.4', 'groupId': 'OG000'}, {'value': '18.33', 'spread': '30.6', 'groupId': 'OG001'}]}]}, {'title': 'SF-12_Changes from Basal - Physical function 6 m', 'categories': [{'measurements': [{'value': '13.33', 'spread': '26.5', 'groupId': 'OG000'}, {'value': '11.67', 'spread': '32.6', 'groupId': 'OG001'}]}]}, {'title': 'SF-12_Changes from Basal - Physical function 12 m', 'categories': [{'measurements': [{'value': '21.67', 'spread': '22.9', 'groupId': 'OG000'}, {'value': '20.00', 'spread': '30.2', 'groupId': 'OG001'}]}]}, {'title': 'SF-12_Changes from Basal - Physical rol 3 months', 'categories': [{'measurements': [{'value': '2.50', 'spread': '21.2', 'groupId': 'OG000'}, {'value': '4.17', 'spread': '31.2', 'groupId': 'OG001'}]}]}, {'title': 'SF-12_Changes from Basal - Physical rol 6 months', 'categories': [{'measurements': [{'value': '6.67', 'spread': '38.9', 'groupId': 'OG000'}, {'value': '9.17', 'spread': '29.7', 'groupId': 'OG001'}]}]}, {'title': 'SF-12_Changes from Basal - Physical rol 12 months', 'categories': [{'measurements': [{'value': '5.00', 'spread': '34.0', 'groupId': 'OG000'}, {'value': '6.67', 'spread': '30.6', 'groupId': 'OG001'}]}]}, {'title': 'SF-12_Changes from Basal - Emotional rol 3 months', 'categories': [{'measurements': [{'value': '-1.67', 'spread': '22.6', 'groupId': 'OG000'}, {'value': '-5.83', 'spread': '24.5', 'groupId': 'OG001'}]}]}, {'title': 'SF-12_Changes from Basal - Emotional rol 6 months', 'categories': [{'measurements': [{'value': '5.83', 'spread': '33.0', 'groupId': 'OG000'}, {'value': '1.67', 'spread': '15.6', 'groupId': 'OG001'}]}]}, {'title': 'SF-12_Changes from Basal - Emotional rol 12 months', 'categories': [{'measurements': [{'value': '0.00', 'spread': '31.0', 'groupId': 'OG000'}, {'value': '0.83', 'spread': '18.0', 'groupId': 'OG001'}]}]}, {'title': 'SF-12_Changes from Basal - Body pain 3 months', 'categories': [{'measurements': [{'value': '10.0', 'spread': '26.4', 'groupId': 'OG000'}, {'value': '5.00', 'spread': '28.7', 'groupId': 'OG001'}]}]}, {'title': 'SF-12_Changes from Basal - Body pain 6 months', 'categories': [{'measurements': [{'value': '15.00', 'spread': '28.0', 'groupId': 'OG000'}, {'value': '11.67', 'spread': '26.5', 'groupId': 'OG001'}]}]}, {'title': 'SF-12_Changes from Basal - Body pain 12 months', 'categories': [{'measurements': [{'value': '13.33', 'spread': '36.4', 'groupId': 'OG000'}, {'value': '13.33', 'spread': '24.8', 'groupId': 'OG001'}]}]}, {'title': 'SF-12_Changes from Basal - Mental Health 3 months', 'categories': [{'measurements': [{'value': '-5.83', 'spread': '24.5', 'groupId': 'OG000'}, {'value': '3.33', 'spread': '19.7', 'groupId': 'OG001'}]}]}, {'title': 'SF-12_Changes from Basal - Mental Health 6 months', 'categories': [{'measurements': [{'value': '3.33', 'spread': '25.2', 'groupId': 'OG000'}, {'value': '3.33', 'spread': '19.7', 'groupId': 'OG001'}]}]}, {'title': 'SF-12_Changes from Basal - Mental Health 12 months', 'categories': [{'measurements': [{'value': '0.00', 'spread': '14.2', 'groupId': 'OG000'}, {'value': '5.00', 'spread': '18.8', 'groupId': 'OG001'}]}]}, {'title': 'SF-12_Changes from Basal - Vitality 3 months', 'categories': [{'measurements': [{'value': '-6.67', 'spread': '37.2', 'groupId': 'OG000'}, {'value': '1.67', 'spread': '25.8', 'groupId': 'OG001'}]}]}, {'title': 'SF-12_Changes from Basal - Vitality 6 months', 'categories': [{'measurements': [{'value': '-1.67', 'spread': '33.4', 'groupId': 'OG000'}, {'value': '1.67', 'spread': '25.8', 'groupId': 'OG001'}]}]}, {'title': 'SF-12_Changes from Basal - Vitality 12 months', 'categories': [{'measurements': [{'value': '-8.33', 'spread': '36.2', 'groupId': 'OG000'}, {'value': '-6.67', 'spread': '24.0', 'groupId': 'OG001'}]}]}, {'title': 'SF-12_Changes from Basal - Social function 3 mo', 'categories': [{'measurements': [{'value': '-1.67', 'spread': '27.5', 'groupId': 'OG000'}, {'value': '-1.67', 'spread': '27.5', 'groupId': 'OG001'}]}]}, {'title': 'SF-12_Changes from Basal - Social function 6 mo', 'categories': [{'measurements': [{'value': '6.67', 'spread': '27.5', 'groupId': 'OG000'}, {'value': '-6.67', 'spread': '29.1', 'groupId': 'OG001'}]}]}, {'title': 'SF-12_Changes from Basal - Social function 12 mo', 'categories': [{'measurements': [{'value': '6.67', 'spread': '29.1', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '26.7', 'groupId': 'OG001'}]}]}, {'title': 'SF-12_Changes from Basal - Physical Health 3 mo', 'categories': [{'measurements': [{'value': '3.44', 'spread': '7.8', 'groupId': 'OG000'}, {'value': '3.71', 'spread': '7.6', 'groupId': 'OG001'}]}]}, {'title': 'SF-12_Changes from Basal - Physical Health 6 mo', 'categories': [{'measurements': [{'value': '4.51', 'spread': '7.0', 'groupId': 'OG000'}, {'value': '3.76', 'spread': '9.3', 'groupId': 'OG001'}]}]}, {'title': 'SF-12_Changes from Basal - Physical Health 12 mo', 'categories': [{'measurements': [{'value': '5.42', 'spread': '9.3', 'groupId': 'OG000'}, {'value': '4.59', 'spread': '9.3', 'groupId': 'OG001'}]}]}, {'title': 'SF-12_Changes from Basal - Mental Health 3 mo', 'categories': [{'measurements': [{'value': '-3.56', 'spread': '10.5', 'groupId': 'OG000'}, {'value': '-1.99', 'spread': '8.9', 'groupId': 'OG001'}]}]}, {'title': 'SF-12_Changes from Basal - Mental Health 6 mo', 'categories': [{'measurements': [{'value': '0.44', 'spread': '11.7', 'groupId': 'OG000'}, {'value': '-1.09', 'spread': '7.0', 'groupId': 'OG001'}]}]}, {'title': 'SF-12_Changes from Basal - Mental Health 12 mo', 'categories': [{'measurements': [{'value': '-2.41', 'spread': '8.2', 'groupId': 'OG000'}, {'value': '-1.56', 'spread': '9.1', 'groupId': 'OG001'}]}]}, {'title': 'VAS_Changes from Basal - 3 months', 'categories': [{'measurements': [{'value': '-13.67', 'spread': '30.7', 'groupId': 'OG000'}, {'value': '-7.53', 'spread': '23.6', 'groupId': 'OG001'}]}]}, {'title': 'VAS_Changes from Basal - 6 months', 'categories': [{'measurements': [{'value': '-20.67', 'spread': '29.3', 'groupId': 'OG000'}, {'value': '-11.93', 'spread': '20.6', 'groupId': 'OG001'}]}]}, {'title': 'VAS_Changes from Basal - 12 months', 'categories': [{'measurements': [{'value': '-21.20', 'spread': '28.5', 'groupId': 'OG000'}, {'value': '-13.07', 'spread': '21.6', 'groupId': 'OG001'}]}]}, {'title': 'LEQUESNE_Changes from Basal - 3 months', 'categories': [{'measurements': [{'value': '-3.63', 'spread': '12.4', 'groupId': 'OG000'}, {'value': '-5.18', 'spread': '12.8', 'groupId': 'OG001'}]}]}, {'title': 'LEQUESNE_Changes from Basal - 6 months', 'categories': [{'measurements': [{'value': '-13.95', 'spread': '10.8', 'groupId': 'OG000'}, {'value': '-5.46', 'spread': '13.4', 'groupId': 'OG001'}]}]}, {'title': 'LEQUESNE_Changes from Basal - 12 months', 'categories': [{'measurements': [{'value': '-8.76', 'spread': '12.4', 'groupId': 'OG000'}, {'value': '-3.13', 'spread': '12.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to one year', 'description': 'Clinical review, questionaires for pain, disability and quality of life at 0, 3, 6 and 12 months.\n\nWOMAC (Western Ontario and McMaster Universities Osteoarthritis Index): Questionnaire to quantify the pain, stiffness and physical function in patients with osteoarthritis of the knee or hip.\n\nSF-12 (Short Form 12, an abbreviated form of SF36) is a questionnaire for the detection of changes in quality of life.\n\nThe visual analogue scale (VAS) is a psychometric response scale which can be used for subjective measurements of knee pain.\n\nLEQUESNE algofunctional index: is a composite measure of pain and disability, with specific self-report questionnaires for knee (osteoarthritis).\n\nAll the scale ranges ranges (minimum and maximum scores) are between 0 and 100%.\n\nValues are given in differences from baseline (usually negative values). More negative values show more improvement on both scales.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Evolution of Cartilage Degeneration by T2 Relaxation Measurements in MRI (Cartigram)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Allogenic Mesenchymal Stromal Cells', 'description': 'Mesenchymal stem cells (MSC) prepared from bone marrow from healthy donor expanded ex vivo for 3-4 weeks. Intraarticular injection of 40 millions MSC.\n\nInjection of Mesenchymal Stromal Cells: Mesenchymal stem cells prepared from bone marrow of healthy donors and expanded for 3-4 weeks according to our procedure described in PEI Num. 10-134, authorized by the Spanish Medicine Agency'}, {'id': 'OG001', 'title': 'Hyaluronic Acid (Durolane)', 'description': 'Intraarticular injection of hyaluronic acid (60 mg)\n\nHyaluronic Acid: Intra-articular injection of 60 mg of hyaluronic acid (Durolane) in a single injection (3 ml)'}], 'classes': [{'title': 'MRI. Nº of values between 50-90 per visit. 0', 'categories': [{'measurements': [{'value': '12.33', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '13.53', 'spread': '5.7', 'groupId': 'OG001'}]}]}, {'title': 'MRI. Nº of values between 50-90 per visit. 6', 'categories': [{'measurements': [{'value': '9.33', 'spread': '4.5', 'groupId': 'OG000'}, {'value': '11.73', 'spread': '7.5', 'groupId': 'OG001'}]}]}, {'title': 'MRI.Nº of values between 50-90 per visit.12.', 'categories': [{'measurements': [{'value': '8.25', 'spread': '5.6', 'groupId': 'OG000'}, {'value': '10.73', 'spread': '5.5', 'groupId': 'OG001'}]}]}, {'title': 'MRI. Change of Nº of measurements. 6', 'categories': [{'measurements': [{'value': '-3.00', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '-1.80', 'spread': '5.8', 'groupId': 'OG001'}]}]}, {'title': 'MRI. Change of Nº of measurements.12', 'categories': [{'measurements': [{'value': '-4.08', 'spread': '6.0', 'groupId': 'OG000'}, {'value': '-2.80', 'spread': '4.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to one year', 'description': 'Magnetic Resonance imaging measurements of T2 relaxation (Cartigram) performed at 0, 6 and 12 months to quantify articular cartilage degeneration. The values (in milliseconds) are T1/2 for decay of the T2 MRI signals. Normal values are below 50 ms; values above 50 ms correspond to inflamed cartilage.\n\nMean (SD) are expressed as the number of values (of a total of 88 measurements) that are between 50 and 90 ms. A value =\\<4.4 is considered normal (can be attained by chance). Values above 4.4 are considered pathological. The worst possible is 88.', 'unitOfMeasure': 'number of values (range 0-88)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy endpoint analysis will be based on all patients who have not committed major protocol violations, and have at least one assessment of efficacy of the end graft. 3 patients of the allogenic MSC treatment group were excluded from this analysis because of incomplete measurements.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Allogenic Mesenchymal Stromal Cells', 'description': 'Mesenchymal stem cells (MSC) prepared from bone marrow from healthy donor expanded ex vivo for 3-4 weeks. Intraarticular injection of 40 millions MSC.\n\nInjection of Mesenchymal Stromal Cells: Mesenchymal stem cells prepared from bone marrow of healthy donors and expanded for 3-4 weeks according to our procedure described in PEI Num. 10-134, authorized by the Spanish Medicine Agency'}, {'id': 'FG001', 'title': 'Hyaluronic Acid (Durolane)', 'description': 'Intraarticular injection of hyaluronic acid (60 mg)\n\nHyaluronic Acid: Intra-articular injection of 60 mg of hyaluronic acid (Durolane) in a single injection (3 ml)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '30 patients were included between 26/Jul/2012 (Pat. 01) and12/Dic/2012 (Pat. 30).', 'preAssignmentDetails': 'All patients fulfilled the selection criteria, were randomized and received the assigned medication.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Allogenic Mesenchymal Stromal Cells', 'description': 'Mesenchymal stem cells (MSC) prepared from bone marrow from healthy donor expanded ex vivo for 3-4 weeks. Intraarticular injection of 40 millions MSC.\n\nInjection of Mesenchymal Stromal Cells: Mesenchymal stem cells prepared from bone marrow of healthy donors and expanded for 3-4 weeks according to our procedure described in PEI Num. 10-134, authorized by the Spanish Medicine Agency'}, {'id': 'BG001', 'title': 'Hyaluronic Acid (Durolane)', 'description': 'Intraarticular injection of hyaluronic acid (60 mg)\n\nHyaluronic Acid: Intra-articular injection of 60 mg of hyaluronic acid (Durolane) in a single injection (3 ml)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.60', 'spread': '9.57', 'groupId': 'BG000'}, {'value': '57.33', 'spread': '9.41', 'groupId': 'BG001'}, {'value': '56.97', 'spread': '9.33', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Spain', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-26', 'studyFirstSubmitDate': '2012-04-23', 'resultsFirstSubmitDate': '2014-09-24', 'studyFirstSubmitQcDate': '2012-04-24', 'lastUpdatePostDateStruct': {'date': '2015-10-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-11-04', 'studyFirstPostDateStruct': {'date': '2012-04-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-11-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Adverse Events as a Measure of Safety and Tolerability', 'timeFrame': 'Up to one year', 'description': 'Adverse events reported. Clinical review and questionaires for pain, disability and quality of life at 0, 3, 6 and 12 months'}], 'secondaryOutcomes': [{'measure': 'Pain and Disability Evolution (WOMAC, Visual Analogue Scale, Lequesne Index and SF-12 Scores)', 'timeFrame': 'up to one year', 'description': 'Clinical review, questionaires for pain, disability and quality of life at 0, 3, 6 and 12 months.\n\nWOMAC (Western Ontario and McMaster Universities Osteoarthritis Index): Questionnaire to quantify the pain, stiffness and physical function in patients with osteoarthritis of the knee or hip.\n\nSF-12 (Short Form 12, an abbreviated form of SF36) is a questionnaire for the detection of changes in quality of life.\n\nThe visual analogue scale (VAS) is a psychometric response scale which can be used for subjective measurements of knee pain.\n\nLEQUESNE algofunctional index: is a composite measure of pain and disability, with specific self-report questionnaires for knee (osteoarthritis).\n\nAll the scale ranges ranges (minimum and maximum scores) are between 0 and 100%.\n\nValues are given in differences from baseline (usually negative values). More negative values show more improvement on both scales.'}, {'measure': 'Evolution of Cartilage Degeneration by T2 Relaxation Measurements in MRI (Cartigram)', 'timeFrame': 'up to one year', 'description': 'Magnetic Resonance imaging measurements of T2 relaxation (Cartigram) performed at 0, 6 and 12 months to quantify articular cartilage degeneration. The values (in milliseconds) are T1/2 for decay of the T2 MRI signals. Normal values are below 50 ms; values above 50 ms correspond to inflamed cartilage.\n\nMean (SD) are expressed as the number of values (of a total of 88 measurements) that are between 50 and 90 ms. A value =\\<4.4 is considered normal (can be attained by chance). Values above 4.4 are considered pathological. The worst possible is 88.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Knee degenerative disease', 'osteoarthritis', 'gonarthrosis', 'stem cell', 'cellular therapy', 'regenerative therapy', 'Mesenchymal stem cells', 'Bone marrow', 'musculoskeletal Diseases', 'Mesenchymal Stromal Cells (allogenic)'], 'conditions': ['Osteoarthritis, Knee', 'Arthritis of Knee', 'Knee Osteoarthritis']}, 'referencesModule': {'references': [{'pmid': '21792091', 'type': 'BACKGROUND', 'citation': 'Orozco L, Soler R, Morera C, Alberca M, Sanchez A, Garcia-Sancho J. Intervertebral disc repair by autologous mesenchymal bone marrow cells: a pilot study. Transplantation. 2011 Oct 15;92(7):822-8. doi: 10.1097/TP.0b013e3182298a15.'}, {'pmid': '23680930', 'type': 'BACKGROUND', 'citation': 'Orozco L, Munar A, Soler R, Alberca M, Soler F, Huguet M, Sentis J, Sanchez A, Garcia-Sancho J. Treatment of knee osteoarthritis with autologous mesenchymal stem cells: a pilot study. Transplantation. 2013 Jun 27;95(12):1535-41. doi: 10.1097/TP.0b013e318291a2da.'}, {'pmid': '24887752', 'type': 'BACKGROUND', 'citation': 'Orozco L, Munar A, Soler R, Alberca M, Soler F, Huguet M, Sentis J, Sanchez A, Garcia-Sancho J. Treatment of knee osteoarthritis with autologous mesenchymal stem cells: two-year follow-up results. Transplantation. 2014 Jun 15;97(11):e66-8. doi: 10.1097/TP.0000000000000167. No abstract available.'}, {'pmid': '25822648', 'type': 'DERIVED', 'citation': 'Vega A, Martin-Ferrero MA, Del Canto F, Alberca M, Garcia V, Munar A, Orozco L, Soler R, Fuertes JJ, Huguet M, Sanchez A, Garcia-Sancho J. Treatment of Knee Osteoarthritis With Allogeneic Bone Marrow Mesenchymal Stem Cells: A Randomized Controlled Trial. Transplantation. 2015 Aug;99(8):1681-90. doi: 10.1097/TP.0000000000000678.'}], 'seeAlsoLinks': [{'url': 'http://www.red-tercel.com', 'label': 'Cell Therapy Network'}, {'url': 'http://www.ncbi.nlm.nih.gov/mesh/68020370', 'label': 'osteoarthritis, knee'}, {'url': 'http://www.ncbi.nlm.nih.gov/mesh?term=cell%2C%20mesenchymal%20stem', 'label': 'mesenchymal stem cells'}]}, 'descriptionModule': {'briefSummary': 'In this study we want to evaluate the clinical use of allogenic mesenchymal stem cells (MSC), obtained from bone marrow of healthy donors, for treatment of knee osteoarthritis. The trial is based in our own previous results with autologous MSC (ongoing NCT01183728 trial). We propose here a multicenter, phase I-II clinical trial, prospective, randomized, blinded, and controlled for the treatment of osteoarthritis (degrees II and III and IV). The assay consists of two arms with 15 patients each one. Patients in the experimental arm will be given an intra-articular transplantation of allogenic MSC, expanded "Ex Vivo" with our GMP-compliant procedure (MSV, PEI No. 10-134, authorized by the Competent Authority; same as in NCT01183728). In the control arm a standard treatment with intra-articular injection of hyaluronic acid shall be given. We shall follow the evolution of pain, disability, quality of life and quantitative changes in structure and composition of cartilage determined by T2-weighted MRI relaxation (Cartigram) for one year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Knee osteoarthritis grade II, III and IV of Kellgren and Lawrence assessed by two observers.\n* Chronic knee pain with mechanical characteristics.\n* No local or systemic septic process.\n* Haematological and biochemical analysis without significant alterations that contraindicate treatment.\n* Informed written consent of the patient.\n* The patient is able to understand the nature of the study\n\nExclusion Criteria:\n\n* Age over 75 or under 18 years or legally dependent\n* Present Infection (to be included in the study no signs of infection must be evidenced)\n* Congenital or acquired malformation resulting in significant deformity of the knee (varus\\<10º; valgus\\<20º) and leading to problems in application or evaluation of results.\n* Overweight expressed as body mass index (BMI) greater than 30.5 (obesity grade II). BMI estimated as mass (kg) / corporal surface (m2).\n* Women who are pregnant or intend to become pregnant or breast-feeding\n* Neoplasia\n* Immunosuppressive states\n* Intra-articular infiltartion of any treatments in the last 3 months previous to study inclusion\n* Participation in another clinical trial or treatment with a different investigational product within 30 days prior to inclusion in the study.\n* Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria'}, 'identificationModule': {'nctId': 'NCT01586312', 'acronym': 'MSV_allo', 'briefTitle': 'Treatment of Knee Osteoarthritis With Allogenic Mesenchymal Stem Cells', 'organization': {'class': 'INDUSTRY', 'fullName': 'Red de Terapia Celular'}, 'officialTitle': 'Treatment of Knee Osteoarthritis With Allogenic Mesenchymal Stem Cells (MSV*) *MSV: Mesenchymal Stromal Cells From Valladolid', 'orgStudyIdInfo': {'id': 'TerCel004'}, 'secondaryIdInfos': [{'id': '2011-005321-51', 'type': 'EUDRACT_NUMBER'}, {'id': 'EC11-309', 'type': 'OTHER_GRANT', 'domain': 'Spanish Ministry of Health, Independent Clinical Investigatio'}, {'id': 'MSV_allo', 'type': 'REGISTRY', 'domain': 'Protocol code'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Allogenic mesenchymal stromal cells injection', 'description': 'Mesenchymal stem cells (MSC) prepared from bone marrow from healthy donor expanded ex vivo for 3-4 weeks. Intraarticular injection of 40 millions MSC.', 'interventionNames': ['Other: Allogenic mesenchymal stromal cells injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Hyaluronic acid (Durolane)', 'description': 'Intraarticular injection of hyaluronic acid (60 mg)', 'interventionNames': ['Drug: Hyaluronic Acid']}], 'interventions': [{'name': 'Allogenic mesenchymal stromal cells injection', 'type': 'OTHER', 'otherNames': ['MSV', 'Mesenchymal Stem Cells', 'MSC'], 'description': 'Mesenchymal stem cells prepared from bone marrow of healthy donors and expanded for 3-4 weeks according to our procedure described in PEI Num. 10-134, authorized by the Spanish Medicine Agency', 'armGroupLabels': ['Allogenic mesenchymal stromal cells injection']}, {'name': 'Hyaluronic Acid', 'type': 'DRUG', 'otherNames': ['Hyaluronic acid, durolane, CE mark:516407'], 'description': 'Intra-articular injection of 60 mg of hyaluronic acid (Durolane) in a single injection (3 ml)', 'armGroupLabels': ['Hyaluronic acid (Durolane)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08022', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Centro Medico Teknon', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '47003', 'city': 'Valladolid', 'state': 'Valladolid', 'country': 'Spain', 'facility': 'Hospital Clinico Universitario', 'geoPoint': {'lat': 41.65541, 'lon': -4.72353}}], 'overallOfficials': [{'name': 'Javier García-Sancho, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Valladolid, Scientific Park'}, {'name': 'Aurelio Vega, MD,PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital Clinico Universitario, Valladolid'}, {'name': 'Luis Orozco, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Centro Médico Teknon, Barcelona'}, {'name': 'Ana Sanchez, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Director, Cell Production Unit, Parque Científico UVa'}, {'name': 'Jose M Moraleda, MD. PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Virgen de la Arrixaca University Hospital, Murcia, Spain'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Red de Terapia Celular', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of Valladolid', 'class': 'OTHER'}, {'name': 'Sanidad de Castilla y León', 'class': 'OTHER'}, {'name': 'Centro Medico Teknon', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}