Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2026-03-15 @ 1:07 AM
Study NCT ID:
NCT02501018
Status:
COMPLETED
Last Update Posted:
2024-10-09
First Post:
2015-07-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Assess the Efficacy and Safety of CLBS12 in Patients with Critical Limb Ischemia (CLI)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000089802', 'term': 'Chronic Limb-Threatening Ischemia'}, {'id': 'D013919', 'term': 'Thromboangiitis Obliterans'}], 'ancestors': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D014657', 'term': 'Vasculitis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000721148', 'term': 'betibeglogene autotemcel'}, {'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2022-05-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-07', 'studyFirstSubmitDate': '2015-07-14', 'studyFirstSubmitQcDate': '2015-07-15', 'lastUpdatePostDateStruct': {'date': '2024-10-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-07-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-05-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to continuous CLI-free status', 'timeFrame': '1 year', 'description': 'CLI-free is determined by assessing the Rutherford score (\\</=3) by the investigator and a central adjudication committee.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CLI, ASO, TAO'], 'conditions': ['Critical Limb Ischemia', 'Buerger Disease', 'Thromboangiitis Obliterans', 'Atherosclerosis Obliterans']}, 'descriptionModule': {'briefSummary': "A prospective, open label, controlled, randomized, double arm, multi-center study to assess the efficacy and safety of CLBS12 in patients with critical limb ischemia (CLI) due to arteriosclerosis obliterans (ASO) with a single arm sub-study to assess the safety and potential efficacy of CLBS12 in patients with CLI due to Buerger's Disease (BD).", 'detailedDescription': 'Main ASO Study: This study will compare safety and efficacy of intramuscular transplantation of autologous CD34+ cells (CLBS12) plus standard of care (SOC) pharmacotherapy (cell treatment arm) versus SOC pharmacotherapy alone (e.g., antiplatelets, anticoagulants, and vasodilators including prostanoids) (control arm) in subjects with CLI categorized as Rutherford score 4 or 5 due to ASO aged 20 to 85 years and with no endovascular or surgical revascularization options. Subjects assigned to the cell treatment arm will continue SOC pharmacotherapy and will also receive subcutaneous injections of GRAN® 5 ug/kg/day for 5 days and undergo apheresis on the last day of GRAN® administration. Then each subject in the cell treatment arm will receive intramuscular injections of autologous CD34+ cells. Subjects assigned to the control arm will continue to receive SOC pharmacotherapy alone with the possibility of receiving cell treatment via the rescue option.\n\nBD Substudy: A single arm substudy is included to assess the safety and efficacy of intramuscular transplantation of CLBS12 in patients (N=\\~5) with CLI categorized as 4 or 5 Rutherford score due to BD aged 20 to 85 years. Subjects who give informed consent will be screened for eligibility within 28 days before registration. Subjects will continue SOC pharmacotherapy and will also receive subcutaneous injections of GRAN® 5 µg/kg/day for 5 days (Pretreatment Days 1 5) to mobilize CD34+ cells into the peripheral blood and undergo apheresis on pretreatment Day 5 to collect CD34+ cells. The choice of pharmacotherapy will be made by the investigators.\n\nEach subject in a cell treatment arm will receive intramuscular injections of up to 1 × 10\\^6 autologous CD34+ cells/kg/limb. All subjects will be evaluated for efficacy and safety assessments during approximately 12 months.\n\nEfficacy assessments include CLI free status, AFS, PFS, ABI, TBI, SPP, TcPO2, ICD, VAS, and AQA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* subject has CLI caused by ASO or BD\n\nExclusion Criteria:\n\n* \\< 20 years old'}, 'identificationModule': {'nctId': 'NCT02501018', 'briefTitle': 'Study to Assess the Efficacy and Safety of CLBS12 in Patients with Critical Limb Ischemia (CLI)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lisata Therapeutics, Inc.'}, 'officialTitle': "A Prospective, Open Label, Controlled, Randomized, Multicenter Study to Assess the Efficacy and Safety of CLBS12 in Patients with Critical Limb Ischemia (CLI) Due to Arteriosclerosis Obliterans (ASO) with a Single-arm Substudy to Assess the Safety and Potential Efficacy of CLBS12 in Patients with CLI Due to Buerger's Disease (BD)", 'orgStudyIdInfo': {'id': 'CLBS12-P01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CLI Due to ASO with CLBS12 + SOC', 'description': 'This group of subjects with CLI due to ASO will be administered with CLBS12 + SOC for collecting efficacy and safety data.', 'interventionNames': ['Biological: CLBS12', 'Drug: SOC']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CLI Due to ASO with SOC', 'description': 'This group of subjects with CLI due to ASO will be administered with SOC only.', 'interventionNames': ['Drug: SOC']}, {'type': 'EXPERIMENTAL', 'label': 'CLI Due to BD with CLBS12', 'description': 'CLBS12 will be administered to patients with CLI due to BD for collecting safety and efficacy data.', 'interventionNames': ['Biological: CLBS12', 'Drug: SOC']}], 'interventions': [{'name': 'CLBS12', 'type': 'BIOLOGICAL', 'otherNames': ['CD34+ cells'], 'description': 'Intramuscular transfusion of CLBS12.', 'armGroupLabels': ['CLI Due to ASO with CLBS12 + SOC', 'CLI Due to BD with CLBS12']}, {'name': 'SOC', 'type': 'DRUG', 'otherNames': ['Standard of care'], 'description': 'Standard of care (SOC) is defined as pharmacotherapy with approved drugs (e.g., antiplatelets, anticoagulants, and vasodilators including prostanoids).', 'armGroupLabels': ['CLI Due to ASO with CLBS12 + SOC', 'CLI Due to ASO with SOC', 'CLI Due to BD with CLBS12']}]}, 'contactsLocationsModule': {'locations': [{'zip': '078-8510', 'city': 'Midorigaoka', 'state': 'Asahikawa-shi', 'country': 'Japan', 'facility': 'Asahikawa Medical University Hospital - 1-1-1 Higashi-2jou', 'geoPoint': {'lat': 34.8, 'lon': 135.4}}, {'city': 'Fukuoka', 'country': 'Japan', 'facility': 'Fukuoka Sanno Hospital', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Kamakura', 'country': 'Japan', 'facility': 'Shonan Kamakura General Hospital', 'geoPoint': {'lat': 35.31085, 'lon': 139.54698}}, {'city': 'Kobe', 'country': 'Japan', 'facility': 'Kobe City Medical Center General Hospital', 'geoPoint': {'lat': 34.6913, 'lon': 135.183}}, {'city': 'Kobe', 'country': 'Japan', 'facility': 'Shinsuma General Hospital', 'geoPoint': {'lat': 34.6913, 'lon': 135.183}}, {'city': 'Osaka', 'country': 'Japan', 'facility': 'Osaka Saiseikai Nakatsu Hospital', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Ōita', 'country': 'Japan', 'facility': 'Oita Oka Hospital', 'geoPoint': {'lat': 33.23333, 'lon': 131.6}}, {'zip': '113-8603', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'Nippon Medical School Hospital', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Keio University Hospital', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Toho University Medical Center Ohashi Hospital', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Tokyo Medical University Hospital', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': "Tokyo Women's Medical University", 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'Kristen K Buck, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Lisata Therapeutics, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lisata Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}