[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Cell Biopeutics Resources Sdn Bhd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":66},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100504921","phase-4-efficacy-and-safety-of-stempeucel-in-patients-with-critical-limb-ischemia-cli-due-to-buergers-disease-100504921",false,"NCT05854615","Efficacy and Safety of Stempeucel® in Patients With Critical Limb Ischemia (CLI) Due to Buerger's Disease","An Observational, Practice-Based, Open Label, Feasibility Study to Observe the Efficacy and Safety of Intramuscular Administration of Stempeucel® in Malaysian Patients With Critical Limb Ischemia (CLI) Due to Buerger's Disease","Inclusion Criteria:\n\n1. Males or females (willing to use accepted methods of contraception during the course of the study) in the age group of 18-65 years.\n2. Buerger's disease as diagnosed by Shionoya criteria\n3. Patients should have at least one ulcer (target ulcer): area between 0.5 to 10 cm2 (both inclusive)\n4. Ankle Brachial Pressure Index (ABPI) ≤ 0.6. If ABPI is ≥ 1.1 then Toe Brachial Index (TBI) will be performed and TBI should be ≤ 0.5\n5. Patients who are able to understand the requirements of the study, and willing to provide voluntary written informed consent, abide by the study requirements, and agree to return for required follow-up visits\n\nExclusion Criteria:\n\n1. Patients diagnosed with atherosclerotic peripheral arterial disease\n2. Patients eligible for surgical or percutaneous revascularization\n3. Patients with a history of participating in another stem cell trial or therapy within 3 months\n4. Patients who are unsuitable to participate the clinical trial as determined by investigators","ALL","18 Years","65 Years",{"count":20,"type":21},3,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","The goal of this observational, practice-based feasibility study is to observe the efficacy and safety of intramuscular administration of Stempeucel® in Malaysian patients with critical limb ischemia (CLI) due to Buerger's disease. The main questions it aims to answer are:\n\n* Can intramuscular administration of Stempeucel® reduce symptoms of CLI due to Buerger's disease while improving the healing rate and functional outcomes?\n* Does intramuscular administration of Stempeucel® causes any serious adverse events in CLI due to Buerger's disease patients? Study patients will be assessed by the PI before administering the Stempeucel® for any other organ with inflammation. The study patients will also be followed up to the duration of 1 year after study treatment administration for safety and efficacy assessment.",[27,28],"Critical Limb Ischemia","Buerger's Disease",[30,31,32],"critical limb ischemia","Buerger's disease","bone marrow derived mesenchymal stem cell","RECRUITING","2025-09-08",{"date":36,"type":37},"2025-09-09","ACTUAL",{"date":39,"type":37},"2024-01-01",{"date":41,"type":21},"2027-12",{"name":43,"class":44},"Cell Biopeutics Resources Sdn Bhd","INDUSTRY",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":62,"startDateStruct":63,"completionDateStruct":64,"leadSponsor":65,"locationsCount":45},"100504923","phase-4-efficacy-and-safety-of-stempeucel-in-patients-with-critical-limb-ischemia-cli-due-to-peripheral-arterial-disease-100504923","NCT05854641","Efficacy and Safety of Stempeucel® in Patients With Critical Limb Ischemia (CLI) Due to Peripheral Arterial Disease","An Observational, Practice-Based, Open Label, Feasibility Study to Observe the Efficacy and Safety of Intramuscular Administration of Stempeucel® in Malaysian Patients With Critical Limb Ischemia (CLI) Due to Peripheral Arterial Disease.","Inclusion Criteria:\n\n* Patients between 18-65 years old\n* Patients diagnosed with atherosclerotic peripheral arterial disease\n* Patients not eligible for or have failed surgical or percutaneous revascularization (No option patients)\n* Patients with at least one ulcer (between 0.5 to 10 cm2 size)\n* Ankle brachial pressure index (ABPI) ≤ 0.6 (toe brachial index (TBI) if ABPI out of range; TBI ≤ 0.5)\n* Patients who are able and willing to provide consent and agrees to comply with study procedures and follow-up evaluations\n\nExclusion Criteria:\n\n* Patients diagnosed with Buerger's disease by Shionoya criteria\n* Patients eligible for surgical or percutaneous revascularization\n* Patients with a history of participating in another stem cell trial or therapy within 3 months\n* Patients who are unsuitable to participate the clinical trial as determined by investigators",{"count":54,"type":21},10,[24],"The goal of this observational, practice-based feasibility study is to observe the efficacy and safety of intramuscular administration of Stempeucel® in Malaysian patients with critical limb ischemia (CLI) due to peripheral arterial disease. The main questions it aims to answer are:\n\n* Can intramuscular administration of Stempeucel® reduce symptoms of CLI due to peripheral arterial disease while improving the healing rate and functional outcomes?\n* Does intramuscular administration of Stempeucel® causes any serious adverse events in CLI due to peripheral arterial disease patients? Study patients will be assessed by the PI before administering the Stempeucel® for any other organ with inflammation. The study patients will also be followed up to the duration of 1 year after study treatment administration for safety and efficacy assessment.",[27,58],"Peripheral Arterial Disease",[30,60,61],"peripheral arterial disease","bone marrow-derived mesenchymal stem cell",{"date":36,"type":37},{"date":39,"type":37},{"date":41,"type":21},{"name":43,"class":44},""]