Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2025-12-28 @ 6:45 PM
Study NCT ID:
NCT01809769
Status:
COMPLETED
Last Update Posted:
2016-04-04
First Post:
2013-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Autologous Adipose Tissue Derived Mesenchymal Stem Cells Therapy for Patients With Knee Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D044382', 'term': 'Population Groups'}], 'ancestors': [{'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-01', 'studyFirstSubmitDate': '2013-03-11', 'studyFirstSubmitQcDate': '2013-03-11', 'lastUpdatePostDateStruct': {'date': '2016-04-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recording of Adverse Events and Serious Adverse Events', 'timeFrame': '12 weeks'}, {'measure': 'Electrocardiogram', 'timeFrame': '9 weeks'}, {'measure': 'Vital signs', 'timeFrame': '9 weeks'}, {'measure': 'Physical examination', 'timeFrame': '9 weeks'}, {'measure': 'WOMAC Score(The Western Ontario and McMaster Universities Osteoarthritis Index)', 'timeFrame': '24 months'}, {'measure': 'Laboratory tests', 'timeFrame': '9 weeks', 'description': 'Routine blood and urine tests, hepatic and renal functions tests, blood lipid and glucose tests, immunologic tests'}], 'secondaryOutcomes': [{'measure': 'SF-36', 'timeFrame': '24 months'}, {'measure': 'NRS-11', 'timeFrame': '24 months'}, {'measure': 'The volume of articular cartilage', 'timeFrame': '24 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Knee Osteoarthritis']}, 'referencesModule': {'references': [{'pmid': '29417902', 'type': 'DERIVED', 'citation': 'Song Y, Du H, Dai C, Zhang L, Li S, Hunter DJ, Lu L, Bao C. Human adipose-derived mesenchymal stem cells for osteoarthritis: a pilot study with long-term follow-up and repeated injections. Regen Med. 2018 Apr;13(3):295-307. doi: 10.2217/rme-2017-0152. Epub 2018 Feb 8.'}]}, 'descriptionModule': {'briefSummary': 'Two injections in total and 3 ml autologous adipose-tissue-derived stem cells(haMSCs) for each injection; time-points for intervention: 1) initial injection; 2) 3 weeks following initial injection.', 'detailedDescription': 'Adipose (fat) tissue is removed by lipo-aspiration (this may take up to 40 minutes). The fat is processed on-site to isolate and obtain the MSCs,then proliferate them. The suspension of the cells is injected into the knee joint under ultrasound guidance. (about 20 minutes).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects who understand and sign the consent form for this study.\n* Age: 40-70, males and females.\n* Clinical diagnosis of degenerative arthritis by Radiographic Criteria of Kellgren and Lawrence.\n* Patients who can't treat with traditional medication and need a arthroplasty.\n* Duration of pain over Grade 4(11-point numeric scale)\\> 4 months.\n\nExclusion Criteria:\n\n* Women who are pregnant or breast feeding or planning to become pregnant during the study.\n* Objects who administer with a anti-inflammatory drugs within 14 days prior to inclusion in the study.\n* History or current evidence of alcohol or drug abuse or is a recreational user of illicit drugs or prescription medications.\n* Treatment with intra-articular injection therapy within 2 months prior to screen.\n* Other joint diseases except degenerative arthritis : systemic or rheumatic or inflammatory chondropathy, chondrocalcinosis, hemachromatosis, inflammatory joint disease, avascular necrosis of the femoral head, Paget's disease, hemophilic arthropathy, infectional arthritis, Charcot's disease, villonodular synovitis, synovial chondromatosis.\n* Positive serology for HIV-1 or HIV-2, Hepatitis B (HBsAg, Anti-HCV-Ab), Hepatitis C (Anti-HCV-Ab) and syphilis.\n* Serious pre-existing medical conditions like Cardiovascular Diseases, Renal Diseases, Liver Diseases, Endocrine Diseases, Cancer and Diabetes Mellitus.\n* Overweight expressed as body mass index (BMI) greater than 30 (obesity grade II).\n* Participation in another clinical trial or treatment with a different investigational product within 3 months prior to inclusion in the study.\n* Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria."}, 'identificationModule': {'nctId': 'NCT01809769', 'briefTitle': 'Autologous Adipose Tissue Derived Mesenchymal Stem Cells Therapy for Patients With Knee Osteoarthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shanghai AbelZeta Ltd.'}, 'officialTitle': 'Autologous Adipose Tissue Derived Mesenchymal Stem Cells Therapy for Patients With Knee Osteoarthritis by Intra-articular Injection: A PhaseⅠ/Ⅱa, Randomized and Double-blinded Clinical Trial', 'orgStudyIdInfo': {'id': 'CBMG-KOA-1.1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mesenchymal stem cells low-dose group', 'description': 'Biological: Mesenchymal progenitor cells. Administrated for intra-articular use. Dosage: 1 x 10 E7 cells (3 ml), Frequency: 0,3 weeks.', 'interventionNames': ['Biological: Mesenchymal stem cells low-dose group']}, {'type': 'EXPERIMENTAL', 'label': 'Mesenchymal stem cells mid-dose group', 'description': 'Biological: Mesenchymal progenitor cells. Administrated for intra-articular use. Dosage: 2 x 10 E7 cells (3 ml). Frequency: 0,3 weeks.', 'interventionNames': ['Biological: Mesenchymal stem cells mid-dose group']}, {'type': 'EXPERIMENTAL', 'label': 'Mesenchymal stem cells high-dose group', 'description': 'Biological: Mesenchymal progenitor cells. Administrated for intra-articular use. Dosage:5 x 10 E7 cells (3 ml). Frequency: 0,3 weeks.', 'interventionNames': ['Biological: Mesenchymal stem cells high-dose group']}], 'interventions': [{'name': 'Mesenchymal stem cells low-dose group', 'type': 'BIOLOGICAL', 'otherNames': ['Adipose tissue derived mesenchymal stem cells'], 'description': 'Biological: Adipose tissue derived mesenchymal stem cells administrated for intra-articular use', 'armGroupLabels': ['Mesenchymal stem cells low-dose group']}, {'name': 'Mesenchymal stem cells mid-dose group', 'type': 'BIOLOGICAL', 'otherNames': ['Adipose tissue derived mesenchymal stem cells'], 'description': 'Biological: Adipose tissue derived mesenchymal stem cells administrated for intra-articular use', 'armGroupLabels': ['Mesenchymal stem cells mid-dose group']}, {'name': 'Mesenchymal stem cells high-dose group', 'type': 'BIOLOGICAL', 'otherNames': ['Adipose tissue derived mesenchymal stem cells'], 'description': 'Biological: Adipose tissue derived mesenchymal stem cells administrated for intra-articular use', 'armGroupLabels': ['Mesenchymal stem cells high-dose group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200127', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Department of Rheumatology,Ren Ji Hospital,School of Medicine,Shanghai Jiao Tong University,Shanghai,China', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Chunde Bao, M.D. & Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Rheumatology,Ren Ji Hospital,School of Medicine,Shanghai Jiao Tong University,Shanghai,China'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai AbelZeta Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'RenJi Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}