[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100425461":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":19,"locations":25,"responsibleParty":45,"collaborators":19,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":19,"eligibilityCriteria":52,"healthyVolunteers":49,"sex":53,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":19,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":69,"whyStopped":19,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"The Nordic Network For Clinical Islet Transplantation","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Autologous Tregs in allogenic islet transplantation","EXPERIMENTAL","Autologous Tregs are given simultaneously to the patient with the islets",[13],"Other: Autologous T regulatory cells",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"Autologous T regulatory cells","Enriched autologous T regulatory cells are given back to the patient at the time of islet transplantation",[9],null,[21],{"name":22,"affiliation":23,"role":24},"Torbjörn Lundgren, MD","Karolinska University Hospital","PRINCIPAL_INVESTIGATOR",[26,37],{"facility":23,"status":19,"city":27,"state":19,"zip":28,"country":29,"countryCode":30,"cosmosGeoPoint":31,"geoPoint":36,"contacts":19},"Stockholm","14186","Sweden","SE",{"type":32,"coordinates":33},"Point",[34,35],18.06871,59.32938,{"lat":35,"lon":34},{"facility":38,"status":19,"city":39,"state":19,"zip":19,"country":29,"countryCode":30,"cosmosGeoPoint":40,"geoPoint":44,"contacts":19},"Uppsala University Hospital","Uppsala",{"type":32,"coordinates":41},[42,43],17.63889,59.85882,{"lat":43,"lon":42},{"type":46,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100425461","infusion-of-autologous-t-regulatory-cells-t-reg-at-the-time-of-transplantation-of-allogenic-islets-of-langerhans-100425461",false,"NCT04820270","Infusion of Autologous T Regulatory Cells (T Reg) at the Time of Transplantation of Allogenic Islets of Langerhans","Inclusion Criteria:\n\n* Patient must be registered on the waiting list within The Nordic Network for Clinical Islet Transplantation\n* Type 1 diabetes with diagnosed \\\u003C40years of age and with\\>5 years of exogenous insulin use\n* C peptide \\\u003C 0.1 nmol\u002FL at MMTT if no previous islet transplant\n* Adequate previous treatment by an experienced diabetologist\n* Patient must understand and be able to sign an informed consent\n\nExclusion Criteria:\n\n* Patient with a previous transplant other than islets\n* Patient with an BMI\\>30\n* Patient with an need of more than 1U\u002Fkg of insulin per 24h\n* Repeated abnormal liver function tests\n* non stable retinopathy\n* known abnormalities in coagulation\n* known malignancies\n* non stable heart conditions\n* active infections\n* serological proof of hepatitis B or C or HIV\n* signs of portal hypertension\n* patients that are pregnant, breast feeding or aim to become pregnant during the study period\n* patients with a PRA \\> 20%, positive cross match or known DSA\n* patients with conditions that the investigator would consider unsafe to combine with islet transplantation","ALL","18 Years","65 Years",{"count":57,"type":58},8,"ESTIMATED","INTERVENTIONAL",[61],"NA","Open single armed study to investigate safety and feasibility of administrating autologous T regulatory cells at the time of allogenic islet transplantation.",[64],"Type1diabetes",[66,67,68],"Transplantation","Islets of Langerhans","T regulatory Cells (autologous)","UNKNOWN","2021-03-25",{"date":72,"type":73},"2021-03-29","ACTUAL",{"date":75,"type":73},"2018-08-20",{"date":77,"type":58},"2021-07-31",{"name":5,"class":6},2]