Mesenchymal Stem Cells for Chronic Kidney Diseases
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 0.9% sodium chloride, MSCs.
- Who it may be relevant to
- Registry conditions: Kidney Disease, Chronic, Diabetic Kidney Disease (DKD), Hypertensive Nephropathy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomized Controlled Study of Mesenchymal Stem Cells in the Treatment of Chronic Kidney Diseases
Overview
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
- Drug 0.9% sodium chloride
The control group will receive a placebo, which is an intravenous infusion of 250 mL of 0.9% sodium chloride injection. - Drug MSCs
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.
Primary outcome measures
- Primary Outcome Measure [Time frame: From enrollment to the end of treatment at 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07240987 · KY20242307