[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602696":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":19,"locations":25,"responsibleParty":44,"collaborators":11,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":11,"eligibilityCriteria":52,"healthyVolunteers":48,"sex":53,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":11,"studyType":59,"phases":60,"briefSummary":63,"conditions":64,"keywords":11,"overallStatus":28,"whyStopped":11,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},{"fullName":5,"class":6},"EndoCell Therapeutics, Inc.","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Allogeneic Human E-islet (E-islet 01)","EXPERIMENTAL",null,[13],"Biological: Allogeneic Human E-islet (E-islet 01)",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":11},"BIOLOGICAL","Allogeneic Human E-islet (E-islet 01), Infused into the hepatic portal vein",[9],[20],{"name":21,"role":22,"phone":23,"phoneExt":11,"email":24},"yanyan ma","CONTACT","+8618621591910","mayanyan@endocell.cn",[26],{"facility":27,"status":28,"city":29,"state":30,"zip":11,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"Shanghai Changzheng Hospital","RECRUITING","Shanghai","Shanghai Municipality","China","CN",{"type":34,"coordinates":35},"Point",[36,37],121.45806,31.22222,{"lat":37,"lon":36},[40],{"name":41,"role":22,"phone":42,"phoneExt":11,"email":43},"Hao Yin","13901677738","yinhaoshanghai@163.com",{"type":45,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100602696","phase-1-a-safety-tolerability-and-efficacy-study-of-e-islet-01-in-participants-with-type-1-diabetes-100602696",false,"NCT07126873","A Safety, Tolerability, and Efficacy Study of E-islet 01 in Participants With Type 1 Diabetes","A Phase 1\u002F2a Study to Evaluate the Safety, Tolerability, and Efficacy of E-islet 01 in Subjects Who Have Type 1 Diabetes Mellitus With Impaired Hypoglycemic Awareness and Severe Hypoglycemia","Inclusion Criteria:\n\n* Clinical history of Type 1 Diabetes with \\> 5 years of duration\n* 2-hour C-peptide level \\\u003C0.3 ng\u002FmL after a mixed meal stimulation test\n* Under continuous insulin therapy, Participants have at least one of the following conditions:\n\n  1. At least one episode of documented severe hypoglycemia in the 12 months prior to enrollment;\n  2. Unaware hypoglycemia evaluated using the Clarke scoring system\n* Willing and able to conduct self-blood glucose monitoring as required, with good compliance\n* Voluntarily participate and sign the informed consent form\n\nExclusion Criteria:\n\n* Uncontrolled systemic infections, including but not limited to pulmonary tuberculosis, active hepatitis, a history of positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), or Treponema pallidum antibody (TP-Ab).\n* History of malignancy within the past 5 years or undergoing antitumor treatment\n* Participation in other clinical trials in the 3 months or islet cell transplant, organ transplant, or cell therapy in the 12 months prior to enrollment\n* Other situations judged by the investigator as unsuitable for participation in the trial","ALL","18 Years","75 Years",{"count":57,"type":58},21,"ESTIMATED","INTERVENTIONAL",[61,62],"PHASE1","PHASE2","This study will evaluate the safety, tolerability and efficacy of E-islet 01 in participants with Type 1 diabetes mellitus (T1D) and impaired awareness of hypoglycemia (IAH) and severe hypoglycemia",[65,66,67],"Diabetes Mellitus, Type 1","Impaired Hypoglycemic Awareness","Severe Hypoglycemia","2025-08-17",{"date":70,"type":71},"2025-08-22","ACTUAL",{"date":73,"type":58},"2025-08-11",{"date":75,"type":58},"2029-12-31",{"name":5,"class":6},1]