[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100504923":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":31,"responsibleParty":57,"collaborators":59,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":19,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":19,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":84,"overallStatus":34,"whyStopped":19,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Cell Biopeutics Resources Sdn Bhd","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Stempeucel®","EXPERIMENTAL","Stempeucel® (Ex-vivo cultured MSCs) supplied in 15 ml cryo bags consisting of 200 million or 150 million MSCs, 85% PlasmaLyte-A, 5% HSA and 10% DMSO in a total volume of 15 ml. Following thawing, 35 ml of PlasmaLyte A will be added to the Stempeucel® to make a total volume of 50 ml (Refer section 6.6 IMP Preparation and Designation). The final concentration of components will be 1.5% HSA and 3% DMSO.",[13],"Biological: Stempeucel®",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"BIOLOGICAL","• Ex-vivo cultured allogeneic mesenchymal stem cells (MSCs) supplied in cryo-bags consisting of 150 or 200 million, suspended in 50 ml of Plasmalyte A containing 1.5% human serum albumin (HSA) and 3% dimethyl sulfoxide (DMSO).",[9],null,[21],{"name":22,"affiliation":23,"role":24},"Hanafiah Harunarashid, MS","National University of Malaysia","PRINCIPAL_INVESTIGATOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":19,"email":30},"Jezamine Lim, PhD","CONTACT","+60176073103","info@cellbiopeutics.com",[32],{"facility":33,"status":34,"city":35,"state":19,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Hospital Canselor Tunku Mukhriz","RECRUITING","Kuala Lumpur","56000","Malaysia","MY",{"type":40,"coordinates":41},"Point",[42,43],101.68653,3.1412,{"lat":43,"lon":42},[46,51,52,55],{"name":47,"role":28,"phone":48,"phoneExt":49,"email":50},"Farhana Raduan, MS","+603-9145","8299","farhana@ppukm.ukm.edu.my",{"name":22,"role":24,"phone":19,"phoneExt":19,"email":19},{"name":53,"role":54,"phone":19,"phoneExt":19,"email":19},"Lenny Suryani Safri, MS","SUB_INVESTIGATOR",{"name":56,"role":54,"phone":19,"phoneExt":19,"email":19},"Mohamad Azim Md Idris, MS",{"type":58,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR",[60,62],{"name":61,"class":6},"Stempeutics Research Pvt Ltd",{"name":23,"class":63},"OTHER","100504923","phase-4-efficacy-and-safety-of-stempeucel-in-patients-with-critical-limb-ischemia-cli-due-to-peripheral-arterial-disease-100504923",false,"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","ALL","18 Years","65 Years",{"count":75,"type":76},10,"ESTIMATED","INTERVENTIONAL",[79],"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 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.",[82,83],"Critical Limb Ischemia","Peripheral Arterial Disease",[85,86,87],"critical limb ischemia","peripheral arterial disease","bone marrow-derived mesenchymal stem cell","2025-09-08",{"date":90,"type":91},"2025-09-09","ACTUAL",{"date":93,"type":91},"2024-01-01",{"date":95,"type":76},"2027-12",{"name":5,"class":6},1]