Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2026-02-23 @ 12:21 PM
Study NCT ID:
NCT02580695
Status:
COMPLETED
Last Update Posted:
2018-12-26
First Post:
2015-10-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess Safety and Efficacy of Umbilical Cord-derived Mesenchymal Stromal Cells in Knee Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2019-04-12', 'releaseDate': '2019-01-17'}], 'estimatedResultsFirstSubmitDate': '2019-01-17'}}, '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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-24', 'studyFirstSubmitDate': '2015-10-15', 'studyFirstSubmitQcDate': '2015-10-19', 'lastUpdatePostDateStruct': {'date': '2018-12-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients who experience an adverse event', 'timeFrame': '12 months', 'description': 'according to National Cancer Institute Common Terminology Criteria for Adverse Effects (NCI-CTCAE)'}], 'secondaryOutcomes': [{'measure': 'Physical function improvement measured by WOMAC OA index', 'timeFrame': '12 months'}, {'measure': 'Change in pain density measured by Visual analogue scale (VAS)', 'timeFrame': '12 months'}, {'measure': 'QoL improvement measured by SF-36', 'timeFrame': '12 months'}, {'measure': 'Changes in WORMS scale measured by knee MRI', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'Knee-osteoarthritis (OA) is a common and disabling problem, that represents a global health issue since none of the current therapies are truly disease modifying. The use of mesenchymal stem cells (MSCs) in OA-preclinical models has been associated with a reduction in cartilage degradation, the attenuation of bone sclerosis and an effective anti-inflammatory response. Investigators have designed a randomized phase I/II placebo controlled trial of UC-MSCs in knee OA. Outcomes will be evaluated at 12 months, comparing monodosis versus double intra-articular injection, re-randomized at 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Symptomatic Knee OA, Kellgren and Lawrence grade I, II, III on plain Rx films.\n* Chondromalacia patella grade I-III on knee MRI. With or without meniscal tear.\n* Stable knee and normal clinical exam of involved extremity\n* Written informed consent for patients.\n\nExclusion Criteria:\n\n* Bilateral symptomatic knee OA\n* Local or systemic infection.\n* Active neoplasia or immunosuppressive state\n* Pregnancy or Breastfeeding\n* Body Mass Index ≥ 30\n* Presence of Pacemaker or Lower extremity metal implant\n* Anticoagulant treatment other than aspirin.\n* Recent use of oral (previous month) or intra-articular (previous 3 months) corticosteroids\n* Concomitant inflammatory joint disease (cristal, connective tissue disease)\n* Valgus (\\>10o) or Varus (\\>5o) deformity of involved extremity\n* Condilar or Tibial plateau Generalized Bone Marrow edema on MRI\n* Significant symptomatic hip or spine disease\n* Significant abnormality in baseline lab tests'}, 'identificationModule': {'nctId': 'NCT02580695', 'briefTitle': 'A Study to Assess Safety and Efficacy of Umbilical Cord-derived Mesenchymal Stromal Cells in Knee Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de los Andes, Chile'}, 'officialTitle': 'A Phase I/II, Randomized, Double-blind, Controlled Study to Assess Safety and Efficacy of Umbilical Cord-derived Mesenchymal Stromal Cells (UC-MSCs) in Patients With Knee Osteoarthritis', 'orgStudyIdInfo': {'id': 'C4COA01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Umbilical-cord mesenchymal stromal cells', 'description': 'Umbilical-cord mesenchymal stromal cells (UC-MSCs)\n\nAllogeneic UC-MSCs 20 x 10e6 diluted on 3 mL of saline solution + 5% of Plasma AB\n\nArm 2a: single infusion group. UC-MSCs at 0 month\n\nArm 2b: double infusion group. UC-MSCs at 0 and 6 months', 'interventionNames': ['Biological: umbilical-cord mesenchymal stromal cells']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Hyaluronic Acid (HA)', 'description': 'Drug: Hyaluronic Acid 3 mL of HA intra-articular injection at baseline and 6 months', 'interventionNames': ['Drug: Hyaluronic Acid']}], 'interventions': [{'name': 'umbilical-cord mesenchymal stromal cells', 'type': 'BIOLOGICAL', 'otherNames': ['UC-MSCs'], 'description': 'Intra-articular knee injection of UC-MSC 20x10e6 at 0 and 6 months', 'armGroupLabels': ['Umbilical-cord mesenchymal stromal cells']}, {'name': 'Hyaluronic Acid', 'type': 'DRUG', 'otherNames': ['Durolane'], 'description': 'Intra-articular knee injection of Hyaluronic Acid (3ml) at 0 and 6 months', 'armGroupLabels': ['Hyaluronic Acid (HA)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Santiago', 'country': 'Chile', 'facility': 'Clinica Universidad de los Andes', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}], 'overallOfficials': [{'name': 'Jose Matas, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad de Los Andes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Francisco Espinoza, MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Alternative Investigator', 'investigatorFullName': 'Francisco Espinoza, MD', 'investigatorAffiliation': 'Universidad de los Andes, Chile'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2019-01-17', 'type': 'RELEASE'}, {'date': '2019-04-12', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Francisco Espinoza, Alternative Investigator, Universidad de los Andes, Chile'}}}}