[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Hangzhou Reprogenix Bioscience, Inc\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":65},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"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":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"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":20,"type":21},10,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28],"Diabete Mellitus","Diabete Type 2","NOT_YET_RECRUITING","2026-09-02",{"date":32,"type":33},"2026-09-08","ACTUAL",{"date":35,"type":21},"2026-09-30",{"date":37,"type":21},"2032-12-30",{"name":39,"class":40},"Hangzhou Reprogenix Bioscience, Inc","INDUSTRY",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":41},"100572280","phase-1-phase-i-clinical-study-to-evaluate-the-safety-and-efficacy-of-rgb-5088-in-patients-with-type-1-diabetes-mellitus-100572280","NCT06731218","Phase I Clinical Study to Evaluate the Safety and Efficacy of RGB-5088 in Patients With Type 1 Diabetes Mellitus","A Single-Center, Single-Arm, Open-Label Phase I Clinical Trial Evaluating the Safety and Efficacy of RGB-5088 Islet Cell Injection in the Treatment of Type 1 Diabetes Mellitus","Key Inclusion Criteria:\n\n* Age: 18-60 years old (including 18 and 60 years old), male and female;\n* Type 1 diabetes patients (including those who have received organ transplantation such as liver and kidney);\n* Stimulated C-peptide \\\u003C 0.3 ng\u002FmL;\n* The patient had at least one severe hypoglycemia within 12 months before being included in the project\n\nKey Exclusion Criteria:\n\n* Type 2 diabetes patients;\n* Untreated proliferative diabetes retinopathy;\n* Serious heart disease;\n* Serious gastrointestinal dysfunction ；\n* Serious psychological diseases；\n* Any history of malignancy;\n* Have a history of tobacco, alcohol and drug abuse;\n* For female subjects: pregnancy test positive, lactation or unwilling to use effective contraceptive measures during the study period, male patients: intent to procreate or unwilling to use effective contraceptive measures during the study period.","60 Years",{"count":20,"type":21},[24],"This Phase I clinical trial is a single-center, single-arm, open-label study aimed at evaluating the safety and therapeutic efficacy of RGB-5088 islet cell transplantation in patients with Type 1 Diabetes Mellitus.",[54,55],"Diabetes Mellitus, Type 1","Diabetes Mellitus","RECRUITING","2025-09-09",{"date":59,"type":33},"2025-09-15",{"date":61,"type":33},"2025-02-17",{"date":63,"type":21},"2031-12-31",{"name":39,"class":40},""]