[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100552979":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":33,"responsibleParty":47,"collaborators":11,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":11,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":11,"studyType":62,"phases":63,"briefSummary":66,"conditions":67,"keywords":70,"overallStatus":75,"whyStopped":11,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Second Affiliated Hospital of Guangzhou Medical University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Stem Cell Derived Exome","EXPERIMENTAL",null,[13],"Drug: Skin drug prepared with exome originated from stem cell",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DRUG","Skin drug prepared with exome originated from stem cell","Skin drug prepared with exome originated from stem cell will be applied to patient with diabetic foot.",[9],[21],{"name":22,"affiliation":5,"role":23},"Zhenfeng Zhang, MD, PhD","PRINCIPAL_INVESTIGATOR",[25,29],{"name":22,"role":26,"phone":27,"phoneExt":11,"email":28},"CONTACT","+862039195966","zhangzhf@gzhmu.edu.cn",{"name":30,"role":26,"phone":31,"phoneExt":11,"email":32},"Bingjia He, MD","+862039195965","464677938@qq.com",[34],{"facility":35,"status":11,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":11},"The Second Affiliated Hospital of Guangzhou Medical University","Guangzhou","Guangdong","510260","China","CN",{"type":42,"coordinates":43},"Point",[44,45],113.25,23.11667,{"lat":45,"lon":44},{"type":48,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100552979","phase-1-stem-cell-derived-exome-for-treatment-of-diabetic-foot-100552979",false,"NCT06480123","Stem Cell Derived Exome for Treatment of Diabetic Foot","Skin Drug Prepared From Stem Cell Derived Exome for Treatment of Diabetic Foot: a Phase II Clinical Trial","Inclusion Criteria:\n\n1. Clinical diagnosis of diabetic foot.\n2. Signed informed consent before recruiting.\n3. Age above 18 years or less than 90 years.\n4. ECOG score \\\u003C 4\n5. Tolerable coagulation function or reversible coagulation disorders\n6. Laboratory examination test within 7 days prior to procedure: WBC≥3.0×10E9\u002FL; Hb≥90g\u002FL； PLT ≥50×10E9\u002FL；INR \\\u003C 2.3 or PT \\\u003C 6 seconds above control；Cr ≤ 145.5 umul\u002FL；Albumin \\> 28 g\u002FL；Total bilirubin \\\u003C 51 μmol\u002FL\n7. Willing and able to comply with scheduled visits, treatment plan and laboratory tests.\n\nExclusion Criteria:\n\n1. Patients participated in clinical trials of equipment or drugs (signed informed consent) within 4 weeks;\n2. Patients accompany by ascites, hepatic encephalopathy and esophageal and gastric varices bleeding;\n3. Any serious accompanying disease, which is expected to have an unknown, impact on the prognosis, include heart disease, inadequately controlled diabetes and psychiatric disorders;\n4. Patients have poor compliance.\n5. Allergic to the skin drug;\n6. Any agents which could affect the absorption or pharmacokinetics of the study drugs\n7. Other conditions that investigator decides not suitable for the trial.","ALL","18 Years","90 Years",{"count":60,"type":61},50,"ESTIMATED","INTERVENTIONAL",[64,65],"PHASE1","PHASE2","This trial is designed to investigate the safety and efficacy of patients with diabetic foot by using stem cell derived exome.",[68,69],"Diabetic Foot","Stem Cell",[71,72,73,74],"Diabetic foot","Stem cell","Exome","Skin drug","NOT_YET_RECRUITING","2024-06-26",{"date":78,"type":79},"2024-06-28","ACTUAL",{"date":81,"type":61},"2024-08-01",{"date":83,"type":61},"2033-12-30",{"name":5,"class":6},1]