A Clinical Study of iPSC-Derived Islet Cells for Diabetes Mellitus Therapy

A Single-Arm, Open-Label Clinical Study of iPSC-Derived Islet Cells for the Treatment of Diabetes Mellitus

This is a single-arm, open-label clinical trial designed to assess the safety and therapeutic efficacy of iPSC-derived islet cell infusion in patients with diabetes mellitus.

Key Inclusion Criteria:

• Subjects aged 18 years or older, of any sex.
• Duration of diabetes > 5 years.
• Body mass index (BMI) 18-35 kg/m².
• Receiving insulin therapy.

Key Exclusion Criteria:

• Presence of HIV infection , or active acute or chronic hepatitis infection (HBV or HCV), or Treponema pallidum infection.
• Active pulmonary tuberculosis or patients undergoing treatment for suspected tuberculosis.
• Uncontrolled systemic fungal, bacterial, viral, or other infections .
• Presence of severe diabetic complications.
• Presence of severe organic lesions in vital organs such as the heart, lungs, or brain.
• History of malignant tumors.