[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641378":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":19,"locations":11,"responsibleParty":25,"collaborators":11,"id":27,"slug":28,"hasResults":29,"nctId":30,"briefTitle":31,"officialTitle":32,"acronym":11,"eligibilityCriteria":33,"healthyVolunteers":29,"sex":34,"minAge":35,"maxAge":36,"enrollmentInfo":37,"targetDuration":11,"studyType":40,"phases":41,"briefSummary":44,"conditions":45,"keywords":48,"overallStatus":50,"whyStopped":11,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":11},{"fullName":5,"class":6},"Seraxis","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"SR-02 allogeneic pancreatic endocrine cell clusters","EXPERIMENTAL",null,[13],"Biological: Allogeneic pancreatic endocrine cell clusters",[15],{"type":16,"name":17,"description":17,"armGroupLabels":18,"otherNames":11},"BIOLOGICAL","Allogeneic pancreatic endocrine cell clusters",[9],[20],{"name":21,"role":22,"phone":23,"phoneExt":11,"email":24},"Director of Clinical Operations","CONTACT","240-308-8681","info@seraxis.com",{"type":26,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100641378","phase-1-study-of-the-safety-and-efficacy-of-pancreatic-endocrine-cells-in-adult-patients-with-type-1-diabetes-100641378",false,"NCT07581197","Study of the Safety and Efficacy of Pancreatic Endocrine Cells in Adult Patients With Type 1 Diabetes","A Phase 1\u002F2 Dose Escalation Study to Evaluate the Safety and Efficacy of SR-02 Pancreatic Endocrine Cell Clusters Implanted in the Omentum of Adults With Type 1 Diabetes (SUGR)","Key Inclusion Criteria\n\n* Adult 18 to 65 years with a clinical history of T1D\n* Diagnosis of T1D at \\\u003C40 years of age\n* Insulin dependence for ≥5 years at pre-screening\n* Recurrent severe hypoglycemia\n* Willingness to use continuous glucose monitoring\n\nKey Exclusion Criteria\n\n* Use of anti-diabetic agent other than insulin(s) or insulin analog(s) within 3 months of Screening\n* Weight loss medication(s) within 3 months of Screening\n\nOther protocol defined Inclusion\u002FExclusion criteria may apply.","ALL","18 Years","65 Years",{"count":38,"type":39},9,"ESTIMATED","INTERVENTIONAL",[42,43],"PHASE1","PHASE2","This study will evaluate the safety, efficacy and durability of SR-02 administered to the omentum of patients of Type 1 diabetes with severe recurrent hypoglycemia. The study will also help establish the optimal treatment dose. Although this study is open to patients with all HLA or blood types, immunosuppression to prevent rejection will be required in this first in human study.",[46,47],"Diabete Mellitus","Diabete Type 1",[49],"Severe hypoglycemia","NOT_YET_RECRUITING","2026-05-06",{"date":53,"type":54},"2026-05-12","ACTUAL",{"date":56,"type":39},"2026-11",{"date":58,"type":39},"2029-11",{"name":5,"class":6}]