A Study of REGEND003 on Patients With Type 2 Diabetes Mellitus (T2DM) and Chronic Kidney Disease (CKD)

Prior treatment

• Presence of severe acute complications of diabetes or CKD requiring hospitalization within 2 weeks prior to screening;
• Presence of severe systemic diseases within 6 months prior to screening and judged by the investigator as unsuitable for the study;
• Patients requiring long-term anticoagulant or antiplatelet therapy who, in the investigator's judgment, cannot discontinue medication 1 week prior to renal puncture/intrarenal injection procedures;
• Patients participated in other clinical trials with interventions within 1 month prior to screening;

Other illness

• At the time of screening, subject who is positive in each of treponema pallidum antibody (TP-Ab), human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody test.
  • Hepatitis B virus carriers with stable current condition can be enrolled. Cured hepatitis C patients with negative result in HCV ribonucleic acid (RNA) test can be enrolled as well.
• Presence of a current or prior history of malignant tumor at screening (with the exception of those with disease-free survival for more than 2 years, or malignancies deemed to be of low aggressiveness as assessed by the investigator).
• Patients with Type 1 Diabetes Mellitus;
• Patients with diagnosis of acute kidney injury, congenital or hereditary kidney diseases, renal atrophy, or other renal conditions deemed ineligible by the investigator, as well as patients with a history of kidney transplantation at screening;
• Patients with suicidal risk, history of psychiatric disorders, or history of epilepsy at screening;
• Patients with severe arrhythmias or heart conduction disorders (degree II or above) in 12-lead ECG test at screening;
• Any condition that, in the investigator's judgment, may increase subject risk or interfere with the clinical trial.

Lab values

• Presence of more than one episode of hypoglycemic coma (blood glucose ≤3.9 mmol/L) within 1 month prior to screening;

Other

• Females who are pregnant, nursing, or planning to be pregnant within a year after using this product (or males whose spouse planning to be pregnant);
• Patients undergoing regular hemodialysis or peritoneal dialysis;
• Patients intolerant to renal puncture/intrarenal injection procedures;
• Subject with assessed survival time of less than 1 year by investigators at screening;
• Investigators, co-investigators, study coordinators, employees of participating investigators or research centers, or family members of the above individuals;

• Male or female, aged 30 to 75 years at the time of signing the informed consent form;
• Diagnosed with Type 2 Diabetes Mellitus for at least 1 year;
• Diagnosed with Chronic Kidney Disease (CKD);
• Voluntarily sign the informed consent form, be able to cooperate in completing study-related procedures and examinations, capable of adequately recording or describing changes in their condition, and demonstrate strong compliance.