[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"EndoCell Therapeutics, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":43},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":26,"conditions":27,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":5},"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":20,"type":21},21,"ESTIMATED","INTERVENTIONAL",[24,25],"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",[28,29,30],"Diabetes Mellitus, Type 1","Impaired Hypoglycemic Awareness","Severe Hypoglycemia","RECRUITING","2025-08-17",{"date":34,"type":35},"2025-08-22","ACTUAL",{"date":37,"type":21},"2025-08-11",{"date":39,"type":21},"2029-12-31",{"name":41,"class":42},"EndoCell Therapeutics, Inc.","OTHER",""]