Autologous Transplantation of Expanded Pancreatic Islet Cells (YD01-2022) in Patients

Inclusion criteria

• ✓. History of diabetes or preoperative diagnosis of hyperglycemia, meeting the diagnostic criteria for diabetes.
• ✓. Previous pancreatic or islet transplantation.
• ✓. Uncontrolled hypertension, such as systolic blood pressure (SBP) \>160 mmHg and/or diastolic blood pressure (DBP) \>100 mmHg despite stable dose (at least 4 weeks) of antihypertensive medication.
• ✓. Known hemoglobin-related diseases, anemia (moderate to severe), or other known hemoglobinopathies that interfere with HbA1c measurement (such as sickle cell disease).
• ✓. Impaired liver or kidney function at screening (reference range from the study center's laboratory): aspartate aminotransferase (AST) \>3 times the upper limit of normal (ULN), alanine aminotransferase (ALT) \>3 times ULN, total bilirubin level (TBL) \>2 times ULN (excluding Gilbert's syndrome). Creatinine clearance rate \<45 mL/min (calculated by the Cockcroft-Gault formula).
• ✓. Significant albuminuria (urinary albumin excretion rate \>300 mg/g) or history thereof.
• ✓. Uncontrolled thyroid disease or adrenal insufficiency.
• ✓. Positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood hepatitis B virus (HBV) DNA ≥104 copies or ≥2000 IU/mL (HBsAg positive with HBV DNA \<2000 IU/mL (\<104/mL) must receive antiviral treatment throughout the study; HBcAb positive with HBV DNA \<2000 IU/mL (\<104/mL) require regular monitoring of HBV DNA quantification throughout the study); Hepatitis C virus (HCV) antibody positive with peripheral blood HCV RNA ≥103 IU/mL; Human immunodeficiency virus (HIV) antibody positive; Active syphilis infection (cured cases may be included); Cytomegalovirus (CMV) DNA positive; Positive nucleic acid test for novel coronavirus (COVID-19).