Type 2 Diabetes Mellitus (T2DM) and Chronic Kidney Disease (CKD)
Conditions
Interventions
Control Group:Placebo
Experimental Group:REGEND003
Sponsors
Shanghai Tongji Hospital
Eligibility
Sex/Gender
All
Age
30 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Male or female, aged 30 to 75 years at the time of signing the informed consent form; 2. Diagnosed with Type 2 Diabetes Mellitus for at least 1 year; 3. Diagnosed with Chronic Kidney Disease (CKD); 4. 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
Exclusion criteria: 1. 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); 2. 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. 3. 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). 4. Patients with Type 1 Diabetes Mellitus; 5. Patients undergoing regular hemodialysis or peritoneal dialysis; 6. Presence of severe acute complications of diabetes or CKD requiring hospitalization within 2 weeks prior to screening; 7. Presence of more than one episode of hypoglycemic coma (blood glucose =3.9 mmol/L) within 1 month prior to screening; 8. Patients intolerant to renal puncture/intrarenal injection procedures; 9. 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; 10. Presence of severe systemic diseases within 6 months prior to screening and judged by the investigator as unsuitable for the study; 11. 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; 12. Patients with suicidal risk, history of psychiatric disorders, or history of epilepsy at screening; 13. Patients with severe arrhythmias or heart conduction disorders (degree II or above) in 12-lead ECG test at screening; 14. Patients participated in other clinical trials with interventions within 1 month prior to screening; 15. Subject with assessed survival time of less than 1 year by investigators at screening; 16. Investigators, co-investigators, study coordinators, employees of participating investigators or research centers, or family members of the above individuals; 17. Any condition that, in the investigator’s judgment, may increase subject risk or interfere with the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse event (AE) associated with the cell therapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Complications associated with intrarenal injection;Change from baseline in C-Reactive Protein;Change from baseline in glomerular filtration rate (GFR);Change from baseline in serum creatinine;Change from baseline in 24-hour urinary protein excretion;Change from baseline in urine albumin-creatinine ratio (UACR);Change from baseline in kidney volume;Change from baseline in renal cortical thickness (RCT);Changes from baseline in the outcomes from Kidney Disease Quality of Life (KDQOL) survey;Change from baseline in blood pressure;Time from injection to first kidney disease progression (KDP); | — |
Countries
China
Contacts
Public ContactChen Yu
Shanghai Tongji Hospital(Tongji Hospital of Tongji University)
Outcome results
None listed