REGEND003 treatment for adults with type 2 diabetes and chronic kidney disease

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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);
* 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 undergoing regular hemodialysis or peritoneal dialysis;
* Presence of severe acute complications of diabetes or CKD requiring hospitalization within 2 weeks prior to screening;
* Presence of more than one episode of hypoglycemic coma (blood glucose ≤3.9 mmol/L) within 1 month prior to screening;
* Patients intolerant to renal puncture/intrarenal injection procedures;
* 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;
* 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 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;
* Patients participated in other clinical trials with interventions within 1 month prior to screening;
* 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;
* Any condition that, in the investigator's judgment, may increase subject risk or interfere with the clinical trial.