[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100645360":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":30,"centralContacts":30,"locations":31,"responsibleParty":81,"collaborators":30,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":30,"eligibilityCriteria":89,"healthyVolunteers":85,"sex":90,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":30,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":102,"overallStatus":104,"whyStopped":30,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Encellin","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort A: ENCRT-103-hPI with standard of care","EXPERIMENTAL","Patients receive standard of care islet infusion and the intervention of an ENCRT implant on the same day. Cohort A also receives standard of care drug regimen for immune management.",[13],"Device: ENCRT-103-hPI encompasses the ENC-103 device, which will be implanted once loaded with primary islet cargo.",{"label":15,"type":10,"description":16,"interventionNames":17},"Cohort B: ENCRT-103-hPI only","Patients receive only an ENCRT implant (the intervention) and a special access drug regimen for immune management.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DEVICE","ENCRT-103-hPI encompasses the ENC-103 device, which will be implanted once loaded with primary islet cargo.","The ENC-103-CED is a unique device on the landscape. It is a soft, device made of non-fibrosis inducing material and design features. ENCRT-103-hPI that will be implanted consists of this device loaded with primary islets.\n\nBoth cohorts A and B will receive the intervention of an ENCRT-103-hPI implant.",[9,15],[25,26,27,28,29],"ENCRT","ENCRT-103","ENCRT-103-hPI","ENC-103","ENC-103-CED",null,[32,48,65],{"facility":33,"status":30,"city":34,"state":35,"zip":30,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Vancouver General Hospital","Vancouver","British Columbia","Canada","CA",{"type":39,"coordinates":40},"Point",[41,42],-123.11934,49.24966,{"lat":42,"lon":41},[45],{"name":46,"role":47,"phone":30,"phoneExt":30,"email":30},"Michael Bleszynski, MD","PRINCIPAL_INVESTIGATOR",{"facility":49,"status":30,"city":50,"state":51,"zip":30,"country":36,"countryCode":37,"cosmosGeoPoint":52,"geoPoint":56,"contacts":57},"UHN","Toronto","Ontario",{"type":39,"coordinates":53},[54,55],-79.39864,43.70643,{"lat":55,"lon":54},[58,63],{"name":59,"role":60,"phone":61,"phoneExt":30,"email":62},"Site coordinator, DDM","CONTACT","416-340-4800","honey.lad@uhn.ca",{"name":64,"role":47,"phone":30,"phoneExt":30,"email":30},"Trevor Reichman, MD",{"facility":66,"status":30,"city":67,"state":68,"zip":30,"country":36,"countryCode":37,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"McGill University Health Centre","Montreal","Quebec",{"type":39,"coordinates":70},[71,72],-73.58781,45.50884,{"lat":72,"lon":71},[75,79],{"name":76,"role":60,"phone":77,"phoneExt":30,"email":78},"Site coordinator","514-934-1934","kerry.mckenna@muhc.mcgill.ca",{"name":80,"role":47,"phone":30,"phoneExt":30,"email":30},"Rohan Kumar, MD",{"type":82,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100645360","phase-1-the-purpose-of-the-study-is-to-evaluate-the-safety-and-performance-of-encrt-103-hpi-in-patients-with-type-i-diabetes-encrt-103-hpi-is-an-implantable-product-shielding-primary-islets-from-the-immune-system-100645360",false,"NCT07680673","The Purpose of the Study is to Evaluate the Safety and Performance of ENCRT-103-hPI in Patients With Type I Diabetes. ENCRT-103-hPI is an Implantable Product Shielding Primary Islets From the Immune System.","Evaluation of ENCRT-103-hPI, an Immune-protected Combination Product Containing Primary Human Islets in Adults With Type 1 Diabetes, With and Without Standard-of-care Portal Vein Islet Infusion.","Inclusion Criteria:\n\n* follows those of the institutions' standard of care (cohort A) or care team's guidelines (cohort B).\n\nExclusion Criteria:\n\n* \\- follows those of the institutions' standard of care (cohort A) or care team's guidelines (cohort B).","ALL","18 Years","75 Years",{"count":94,"type":95},10,"ESTIMATED","INTERVENTIONAL",[98],"PHASE1","This study will evaluate the safety and performance of ENCRT-103-hPI, which is a cargo of primary islets inside Encellin's ENC-103-CED. The 103 offers a soft pillow-like encasing to contain and protect the cells from the immune system. The product is implanted in the upper arm or abdomen and is approximately the size of a quarter. Eligibility is open to both patients on a standard of care islet infusion wait list, as well as those who are not. Participation in this trial does not preclude future Encellin trial participation. The study duration is 4.5months and requires keeping the implant for 4 months, as well as adhering to a standard of care schedule of follow ups during the implant period.",[101],"Type 1 Diabetes",[103],"islets, islet cell transplantation islet transplantation, Diabetes Mellitus, Diabetes Mellitus Type 1, Glucose Metabolism","NOT_YET_RECRUITING","2026-06-29",{"date":107,"type":108},"2026-07-02","ACTUAL",{"date":110,"type":95},"2027-01-06",{"date":112,"type":95},"2029-01",{"name":5,"class":6},3]