Autologous Islet Transplantation for Diabetes

I. Eligibility Criteria:

• Age of 18-75 years (inclusive of 18 and 75) on the day of signing the informed consent form, without gender restriction;
• Type 2 diabetes patients who meet the diagnostic criteria of the "Chinese Diabetes Prevention and Control Guidelines (2024 Edition)";
• Dependent on exogenous insulin therapy;
• Compensatory failure or exhaustion of pancreatic function: ① Fasting serum C-peptide ≤ 1.0 ng/ml in the absence of hypoglycemia (blood glucose > 3.9 mmol/l); ② The average difference ≤ 1.0 ng/ml in serum C-peptide levels at 2, 4, and 6 minutes after arginine stimulation (intravenous injection of 5g arginine) compared to baseline .
• Ability to participate in intensive glucose management with good compliance;
• Mentally stable and able to adhere to the clinical study protocol;
• Possessing full civil capacity and the ability to independently complete a written informed consent form.

II. Exclusion Criteria:

• Inability to tolerate endoscopic ultrasound-guided pancreatic puncture biopsy due to various reasons;
• Inability to tolerate subcostal sheath injection due to various reasons;
• Body mass index (BMI) > 30 kg/m²;
• Un-treated proliferative diabetic retinopathy;
• History of infectious diseases such as hepatitis B, hepatitis C, HIV, and tuberculosis, or presence of active bacterial, fungal, or viral infections (excluding mild localized skin infections);
• Severe heart disease, meeting any of the following criteria: history of recent myocardial infarction (within the past 6 months), myocardial ischemia identified in myocardial function assessment within the past year, or left ventricular ejection fraction <30%;
• Blood pressure: systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg;
• Liver function indicators: Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) are more than twice the upper limit of normal values;
• Glomerular filtration rate (GFR) < 60 ml/min/1.73m²;
• History of invasive aspergillosis, histoplasmosis, or coccidioidomycosis within the past year;
• Laboratory findings showing hemoglobin (Hb) below 90 g/L, or lymphopenia (0.5×10⁹/L), neutropenia (<1.0×10⁹/L), or thrombocytopenia (<75×10⁹/L);
• Patients with any coagulation disorder or other disease requiring long-term anticoagulant therapy, or those with an International Normalized Ratio (INR) > 1.5;
• Female patients: positive pregnancy test, breastfeeding, or unwilling to use effective contraception during the study; male patients: planning to father a child during the study or unwilling to use effective contraception;
• History of prior tumor (excluding completely resected squamous cell carcinoma and cutaneous basal cell carcinoma);
• History of smoking, alcohol abuse, or drug abuse;
• Severe gastrointestinal dysfunction, gastrointestinal immune diseases, peptic ulcers, and other conditions that may interfere with oral drug absorption;
• Have severe mental and psychological disorders;
• Have participated in other clinical trials in the past 3 months;
• History of receiving attenuated live vaccines within 2 months of registration;
• Researchers believe that other reasons make the participant unsuitable for this clinical trial.