Diabetic Kidney Disease (DKD)
Conditions
Keywords
mesenchymal stromal cells(MSCs), Diabetic kidney disease (DKD)
Brief summary
This trial is to evaluate the efficacy and safety of umbilical cord-derived mesenchymal stromal cells (Amimestrocel ) in study subjects with progressive diabetic kidney disease (DKD), to investigate whether Amimestrocel can improve renal function or proteinuria of DKD patients.
Interventions
DRUGAmimestrocel
In the first month (day 1, 14, 28): 1×10\^6 cells per kilogram. From the 8th to the 24th week (week 8, 12, 16, 20, 24): 1.5×10\^6 cells per kilogram.
Sponsors
Chinese PLA General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
- 1. Men and women who are ≥18 and ≤ 80 years old. 2. Diagnosed with type 2 diabetes mellitus. 3. Diagnosed with diabetic kidney disease based on renal pathology within the past 10 years. 4. The 24-hour urine protein quantification is continuously ≥ 3.5 g, or the urine albumin-to-creatinine ratio (UACR) \> 1000 mg/g. 5. The estimated glomerular filtration rate (eGFR) ≥ 15 ml/min/1.73m² (calculated according to the CKD-EPI formula). 6. The blood pressure can be controlled at BP ≤ 160/100 mmHg. 7. Glycated hemoglobin (HbA1c) \< 9%. 8. Willing and able to provide written informed consent.
Exclusion criteria
1. Patients with kidney diseases not caused by diabetes mellitus. 2. Patients who have received treatment with systemic immunosuppressants (such as cyclosporine A, tacrolimus, mycophenolate mofetil, etc.) within 30 days before enrollment and the duration of treatment exceeds one week. 3. Severe cardiovascular diseases, such as congenital heart diseases, atrial fibrillation, NYHA class Ⅲ-IV, unstable angina pectoris, etc. 4. A history of cerebral hemorrhage or cerebral infarction within the past six months (except for those with a history of lacunar cerebral infarction without residual limb movement disorders, cognitive and language function disorders). 5. Patients with severe hyperlipidemia: (serum triglyceride ≥ 6.2 mmol/L, serum low-density lipoprotein cholesterol ≥ 4.1 mmol/L). 6. Hyperkalemia that cannot be controlled through diet or potassium-lowering treatment. 7. Patients with active infections of hepatitis B or hepatitis C viruses (the copy number of HBV DNA or HCV RNA exceeds the upper limit of the normal value); patients with active tuberculosis; patients with severe immunodeficiency diseases, human immunodeficiency virus (HIV) infection, etc. 8. Patients with a history of malignant tumors within the past five years. 9. Patients with a known history of severe allergy to component blood or blood products, or patients with a history of allergy to heterologous proteins. 10. Lactating women, or female patients who have a pregnancy plan or an egg donation plan from the start of the study to the follow-up period, and male patients (or their partners) who have a childbearing plan or a sperm donation plan from the start of the study to the follow-up period and are unwilling to take contraceptive measures. 11. Active infection within one week before enrollment and requiring treatment with intravenous antibiotics. 12. Patients who have participated in other interventional clinical trials within three months before enrollment. 13. The research physician deems that the patient's condition is not suitable for participating in this clinical study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urine protein | Change from baseline at 24 weeks | Urine protein will be measured on 24h urine samples |
| estimated Glomerular Filtration Rate(eGFR) | Change from baseline at 24 weeks | GFR will be estimated by CKD-EPI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| fasting blood glucose | Change from baseline at 24 weeks and then every 6 months to study completion, up to 24 months after cell infusion | fasting blood glucose |
| HbA1c | Change from baseline at 24 weeks and then every 6 months to study completion, up to 24 months after cell infusion | Glycated Hemoglobin A1c |
| Urinary Albumin/Creatinine Ratio(UACR) | Change from baseline at 24 weeks and then every 6 months to study completion, up to 24 months after cell infusion | UACR will be measured on spot morning urine samples |
| proportion of outcome ( ≥50% declined in eGFR，reached end stage renal disease (ESRD), or occured Renal replacement) | proportion of study participants within outcome at 24 weeks and then every 6 months to study completion, up to 24 months after cell infusion | proportion of outcome ( ≥50% declined in eGFR，reached End Stage Renal Disease (ESRD), or occured Renal Replacement Therapy) |
| proportion of major adverse cardiac events(MACE) and all-cause mortality | proportion of study participants within outcome at 24 weeks and then every 6 months to study completion, up to 24 months after cell infusion | proportion of major adverse cardiac events(MACE:CV death, non-fatal CV event(myocardial infarction, stroke, hospitalization for HF)) and all-cause mortality |
| Mechanism exploration | Change from baseline at 4,12,24 weeks and 12 months | Explore the mechanism through blood tests（Serum/plasma concentrations (pg/ml) of biomarkers of inflammation. Proportion/total number of circulating T cells, B cells, NK cells, etc ）. |
| changes in retinal imaging | Change from baseline at 24 weeks and then every 6 months to study completion, up to 24 months after cell infusion | Macular vascular density by Optical Coherence Tomography Angiography （OCTA）， and analyze the percentage of changes in retinal imaging of patients compared to the baseline . |
| Changes in peripheral nerve injury | Change from baseline at 24 weeks and then every 6 months to study completion, up to 24 months after cell infusion | Examine through electromyography, to evaluate the percentage of changes in peripheral nerve injury of patients compared with the baseline. |
| Changes in symptoms | Change from baseline at 24 weeks and then every 6 months to study completion, up to 24 months after cell infusion | The traditional Chinese Medicine（TCM）Syndrome Rating Scale will be used to score TCM symptoms，to evaluate the percentage of changes in the symptoms of patients compared with the baseline. |
| Changes in the quality of life scale | Change from baseline at 24 weeks and then every 6 months to study completion, up to 24 months after cell infusion | The Diabetes Quality-of-Life Measure (DQOL) will be used to score quality of life at each visit, to evaluate the percentage of the change in the DQOL of patients compared to the baseline |
| Adverse Event and Serious Adverse Event（SAE） | within 28 weeks after received Amimestrocel | — |
| secondary malignant disease | within 24 months after received Amimestrocel | Number of Participants with secondary malignant disease |
Countries
China
Contacts
CONTACTxiangmei chen
Outcome results
None listed