[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654098":3},{"organization":4,"outcomesModule":7,"designInfo":26,"detailedDescription":11,"studyPopulation":11,"armGroups":32,"interventions":39,"overallOfficials":43,"centralContacts":48,"locations":54,"responsibleParty":68,"collaborators":11,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":11,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":11,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":11,"overallStatus":90,"whyStopped":11,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Hangzhou Reprogenix Bioscience, Inc","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":18,"otherOutcomes":11},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Safety as assessed by number of subjects with adverse events",null,"From RGB-5088 transplantation to one year later",{"measure":14,"description":11,"timeFrame":15},"Proportion of subjects achieving HbA1c \u003C7.0% or a reduction from baseline ≥1%","On Day180 post RGB-5088 transplantation",{"measure":14,"description":11,"timeFrame":17},"On Day365 post RGB-5088 transplantation",[19,21,24],{"measure":10,"description":11,"timeFrame":20},"From RGB-5088 transplantation to end of study (up to 5 years)",{"measure":22,"description":11,"timeFrame":23},"Proportion of subjects who are insulin independent","From 90 days to end of study (up to 5 years)",{"measure":14,"description":11,"timeFrame":25},"Up to 5 years post RGB-5088 transplantation",{"allocation":27,"interventionModel":28,"interventionModelDescription":11,"primaryPurpose":29,"observationalModel":11,"timePerspective":11,"maskingInfo":30},"NA","SINGLE_GROUP","TREATMENT",{"masking":31,"maskingDescription":11,"whoMasked":11},"NONE",[33],{"label":34,"type":35,"description":36,"interventionNames":37},"RGB-5088","EXPERIMENTAL","Transplantation under the anterior rectus sheath",[38],"Biological: RGB-5088",[40],{"type":41,"name":34,"description":36,"armGroupLabels":42,"otherNames":11},"BIOLOGICAL",[34],[44],{"name":45,"affiliation":46,"role":47},"Linong Ji","Peking University People's Hospital","PRINCIPAL_INVESTIGATOR",[49],{"name":50,"role":51,"phone":52,"phoneExt":11,"email":53},"Linlin Jiang","CONTACT","+86+571-88601920","linlin.jiang@reprogenix.com",[55],{"facility":46,"status":11,"city":56,"state":57,"zip":11,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"Beijing","Beijing Municipality","China","CN",{"type":61,"coordinates":62},"Point",[63,64],116.39723,39.9075,{"lat":64,"lon":63},[67],{"name":45,"role":51,"phone":11,"phoneExt":11,"email":11},{"type":69,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100654098","phase-1-a-clinical-study-to-evaluate-the-safety-and-efficacy-of-rgb-5088-in-patients-with-type-2-diabetes-mellitus-100654098",false,"NCT07794254","A Clinical Study to Evaluate the Safety and Efficacy of RGB-5088 in Patients With Type 2 Diabetes Mellitus","A Single-Arm, Open-Label Phase I Clinical Trial Evaluating the Safety and Efficacy of RGB-5088 Islet Cell Injection in the Treatment of Type 2 Diabetes Mellitus","Inclusion Criteria:\n\n* Age 18-65 years (inclusive), male or female.\n* Diagnosis of type 2 diabetes mellitus (T2DM) with a disease duration ≥5 years.\n* Body mass index (BMI) 18-30 kg\u002Fm².\n* Glycated hemoglobin (HbA1c) 7.0%-10.0%.\n* Adherence to guideline-recommended diet and exercise control; willing and able to comply with lifestyle interventions throughout the study.\n* On insulin therapy following adequate trials of standard and advanced glucose-lowering regimens as per guidelines.\n* Subjects are dependent on insulin therapy.\n* Women of childbearing potential, or male participants whose partners are of childbearing potential, must agree to use highly effective contraception throughout the study and for at least 6 months post-treatment.\n* Able to understand the study protocol, willing to participate voluntarily, and provide signed written informed consent.\n\nExclusion Criteria:\n\n* Diagnosis of any form of diabetes other than T2DM.\n* Daily insulin dose \\>1.5 U\u002Fkg or total daily dose \\\u003C20 U.\n* Fasting plasma glucose ≥15.0 mmol\u002FL.\n* Positive for any diabetes-related autoantibodies at screening (prior to adipose tissue collection).\n* Proliferative diabetic retinopathy requiring treatment or unstable.\n* Active infection; hepatitis B, hepatitis C, syphilis, HIV antibody positivity; or history of tuberculosis.\n* History of major cardiovascular or cerebrovascular disease.\n* Uncontrolled hypertension despite pharmacological therapy.\n* Clinically significant abnormal liver function tests.\n* Clinically significant abnormal renal function tests.\n* Clinically significant abnormalities in hematology parameters.\n* Positive pregnancy test; breastfeeding.\n* History of malignant tumor, except for malignancies with an excellent expected prognosis after curative treatment.\n* History of tobacco dependence, alcohol abuse, substance abuse, or illicit drug use.\n* Use of concomitant medications (other than current antidiabetic agents) that, in the Investigator's opinion, may interfere with glycemic control.\n* Any active autoimmune disease or history of autoimmune disease deemed by the Investigator to be incompatible with study participation.\n* Documented history of a psychiatric disorder.\n* History of hemoglobinopathy, other significant hematological disorders, or any condition causing hemolysis or erythrocyte instability.\n* Participation in another interventional clinical trial within 3 months prior to signing the Informed Consent Form.\n* Prior islet cell infusion\u002Ftransplantation.\n* Receipt of any other stem cell therapy.\n* Judged by the Investigator to have poor compliance or unwillingness to adhere to study procedures.","ALL","18 Years","65 Years",{"count":81,"type":82},10,"ESTIMATED","INTERVENTIONAL",[85],"PHASE1","This Phase I clinical trial is a multi-center, single-arm, open-label study aimed at evaluating the safety and efficacy of RGB-5088 islet cell infusion in patients with Type 2 Diabetes Mellitus.",[88,89],"Diabete Mellitus","Diabete Type 2","NOT_YET_RECRUITING","2026-09-02",{"date":93,"type":94},"2026-09-08","ACTUAL",{"date":96,"type":82},"2026-09-30",{"date":98,"type":82},"2032-12-30",{"name":5,"class":6},1]