Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-01-01 @ 2:06 AM
Study NCT ID:
NCT01601951
Status:
COMPLETED
Last Update Posted:
2014-03-18
First Post:
2012-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcomes Data of Bone Marrow Stem Cells to Treat Hip and Knee Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-14', 'studyFirstSubmitDate': '2012-05-14', 'studyFirstSubmitQcDate': '2012-05-16', 'lastUpdatePostDateStruct': {'date': '2014-03-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analog Pain Scale', 'timeFrame': 'Baseline, 6 weeks, 3 months, 1 year', 'description': 'Change in subjective pain measure'}, {'measure': 'Harris Hip Score or Knee Society Score', 'timeFrame': 'Baeline, 6 weeks, 3 months, 1 year', 'description': 'Change in subjective pain, function, functional activity measurement and a clinical physical exam'}, {'measure': 'Physician Global Assessment', 'timeFrame': 'Baseline, 6 weeks, 3 months, 1 year', 'description': 'Change in physician rated disease activity measurement'}], 'secondaryOutcomes': [{'measure': 'Radiologic', 'timeFrame': 'Baseline, 1 year', 'description': 'Radiographic changes of the hip or knee'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Osteoarthritis', 'Stem Cell Injections', 'Bone Marrow', 'Autologous'], 'conditions': ['Hip and Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if Bone Marrow Concentrate may be successful in the treatment of osteoarthritis. Bone Marrow Concentrate is known to contain a community of cells that has been shown to have "regenerative" properties. This study is designed to evaluate the short-term clinical and x-ray outcomes of injections for hip and knee osteoarthritis.\n\nInclusion Criteria:\n\n* Subjects must be scheduled for an autologous bone marrow hip or knee injection\n* Subjects must have a diagnosis of hip or knee osteoarthritis\n* Subjects must be between the ages of 18 and 85\n* Subjects must be willing and able to sign Informed Consent\n* Subjects must be willing and able to return for scheduled follow-up evaluations\n\nExclusion Criteria:\n\n* Subjects who have had any type of visco-supplementation in the treated joint within the last three months prior to enrollment\n* Subjects for whom baseline data is not available'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Orthopedic clinic, those with a diagnosis of hip or knee osteoarthritis, scheduled for an Autologous Bone Marrow injection', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects must be scheduled for an autologous bone marrow hip or knee injection\n* Subjects must have a diagnosis of hip or knee osteoarthritis\n* Subjects must be between the ages of 18 and 85\n* Subjects must be willing and able to sign Informed Consent\n* Subjects must be willing and able to return for scheduled follow-up evaluations\n\nExclusion Criteria:\n\n* Subjects who have had any type of visco-supplementation in the treated joint within the last three months prior to enrollment\n* Subjects for whom baseline data is not available'}, 'identificationModule': {'nctId': 'NCT01601951', 'briefTitle': 'Outcomes Data of Bone Marrow Stem Cells to Treat Hip and Knee Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'Regenerative Pain Center, Illinois'}, 'officialTitle': 'Autologous Bone Marrow Concentrate Database Outcomes Research Project', 'orgStudyIdInfo': {'id': 'MM-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hip Osteoarthritis', 'interventionNames': ['Other: Procedural, Bone Marrow concentrate injection']}, {'label': 'Knee Osteoarthritis', 'interventionNames': ['Other: Procedural, Bone Marrow concentrate injection']}], 'interventions': [{'name': 'Procedural, Bone Marrow concentrate injection', 'type': 'OTHER', 'description': 'This is strictly data collection and outcomes based. The procedure is not part of this study', 'armGroupLabels': ['Hip Osteoarthritis', 'Knee Osteoarthritis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60016', 'city': 'Des Plaines', 'state': 'Illinois', 'country': 'United States', 'facility': 'Regenerative Pain Center', 'geoPoint': {'lat': 42.03336, 'lon': -87.8834}}], 'overallOfficials': [{'name': 'Mitchell Sheinkop, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Regenerative Pain Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regenerative Pain Center, Illinois', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}