Kidney Disease, Chronic, Diabetic Kidney Disease (DKD), Hypertensive Nephropathy
Conditions
Brief summary
This study will evaluate the effect of intravenous injection of umbilical cord tissue derived mesenchymal stem cells (UMSCs) on the improvement of renal function in patients with chronic kidney disease (CKD) at stage 3 or 4, with the change of estimated glomerular filtration rate (eGFR) as the primary endpoint, and other changes in renal function laboratory indicators, changes in other organ system function laboratory indicators, and adverse reaction events as secondary endpoints. This trial aims to further evaluate the efficacy and safety of UMCSs in CKD patients, and provide new insights into expanding the clinical treatment strategies, delaying the progression and improving the prognosis of CKD patients.
Interventions
DRUG0.9% sodium chloride
The control group will receive a placebo, which is an intravenous infusion of 250 mL of 0.9% sodium chloride injection.
DRUGMSCs
The experimental group will receive an intravenous injection of allogeneic MSCs at a dose of 1.0×10⁶ cells per kilogram, reconstituted with 250 mL of sodium chloride injection.
Sponsors
The First Affiliated Hospital of Air Force Medicial University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Agreement to participate in the trial and provision of signed written informed consent * Pathological diagnosis of diabetic nephropathy or hypertensive renal damage * 15 ≤ eGFR \< 60 mL/min/1.73m², UACR \> 300 mg/g * Age ≥ 18 years
Exclusion criteria
* Extremely severe anemia (hemoglobin \< 30 g/L) * Received blood product transfusion therapy within 1 month * Autosomal dominant or recessive polycystic kidney disease (ADPKD) * History of kidney transplant or other solid organ transplant * Active systemic or localized infection (e.g., pneumonia, osteomyelitis) * Allergy to stem cells themselves or stem cell-related culture medium * History of allergic reaction to cell products (e.g., blood transfusion, platelets) * History of coagulation disorders (thromboembolism, pulmonary embolism, deep vein thrombosis) * History of malignancy or current malignant disease * Elevated tumor markers (AFP, CEA, CA199, CA125, etc.) * Pregnant women or women with plans for pregnancy within 3 months after MSC therapy * Participation in drug-related clinical trials within the past 2 months * Any form of drug abuse, mental illness, or other conditions considered by the investigator as potentially affecting the trial's validity or the subject's health
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Outcome Measure | From enrollment to the end of treatment at 12 months | Efficacy Endpoints: Changes in eGFR, 24-hour urine protein, and UACR at 1, 3, 6, and 12 months will serve as primary endpoints to assess renal function improvement. Changes in other renal function parameters (e.g., quantitative urine protein, urine red blood cells, serum creatinine, cystatin C),and changes in other organ system function parameters (e.g., ECG/echocardiography, complete blood count, liver function, NT-proBNP, parathyroid hormone, 25-dihydroxyvitamin D, lymphocyte subsets) at 1, 3, 6, and 12 months will serve as secondary endpoints. |
Outcome results
None listed