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

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.

Key Inclusion Criteria:

• Age: 18-60 years old (including 18 and 60 years old), male and female;
• Type 1 diabetes patients (including those who have received organ transplantation such as liver and kidney);
• Stimulated C-peptide < 0.3 ng/mL;
• The patient had at least one severe hypoglycemia within 12 months before being included in the project

Key Exclusion Criteria:

• Type 2 diabetes patients;
• Untreated proliferative diabetes retinopathy;
• Serious heart disease;
• Serious gastrointestinal dysfunction ；
• Serious psychological diseases；
• Any history of malignancy;
• Have a history of tobacco, alcohol and drug abuse;
• 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.