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

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.

Inclusion Criteria:

• Age 18-65 years (inclusive), male or female.
• Diagnosis of type 2 diabetes mellitus (T2DM) with a disease duration ≥5 years.
• Body mass index (BMI) 18-30 kg/m².
• Glycated hemoglobin (HbA1c) 7.0%-10.0%.
• Adherence to guideline-recommended diet and exercise control; willing and able to comply with lifestyle interventions throughout the study.
• On insulin therapy following adequate trials of standard and advanced glucose-lowering regimens as per guidelines.
• Subjects are dependent on insulin therapy.
• 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.
• Able to understand the study protocol, willing to participate voluntarily, and provide signed written informed consent.

Exclusion Criteria:

• Diagnosis of any form of diabetes other than T2DM.
• Daily insulin dose >1.5 U/kg or total daily dose <20 U.
• Fasting plasma glucose ≥15.0 mmol/L.
• Positive for any diabetes-related autoantibodies at screening (prior to adipose tissue collection).
• Proliferative diabetic retinopathy requiring treatment or unstable.
• Active infection; hepatitis B, hepatitis C, syphilis, HIV antibody positivity; or history of tuberculosis.
• History of major cardiovascular or cerebrovascular disease.
• Uncontrolled hypertension despite pharmacological therapy.
• Clinically significant abnormal liver function tests.
• Clinically significant abnormal renal function tests.
• Clinically significant abnormalities in hematology parameters.
• Positive pregnancy test; breastfeeding.
• History of malignant tumor, except for malignancies with an excellent expected prognosis after curative treatment.
• History of tobacco dependence, alcohol abuse, substance abuse, or illicit drug use.
• Use of concomitant medications (other than current antidiabetic agents) that, in the Investigator's opinion, may interfere with glycemic control.
• Any active autoimmune disease or history of autoimmune disease deemed by the Investigator to be incompatible with study participation.
• Documented history of a psychiatric disorder.
• History of hemoglobinopathy, other significant hematological disorders, or any condition causing hemolysis or erythrocyte instability.
• Participation in another interventional clinical trial within 3 months prior to signing the Informed Consent Form.
• Prior islet cell infusion/transplantation.
• Receipt of any other stem cell therapy.
• Judged by the Investigator to have poor compliance or unwillingness to adhere to study procedures.