Mesenchymal Stem Cells for Chronic Kidney Diseases

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.

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Key information

Conditions

Kidney Disease, Chronic Chronic Disease Diabetes Complications Diabetes Mellitus Diabetic Kidney Disease (DKD) Diabetic Nephropathies Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hypertensive Nephropathy Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

0.9% Sodium Chloride

Drug

The control group will receive a placebo, which is an intravenous infusion of 250 mL of 0.9% sodium chloride injection.

MSCs

Drug

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 outcomes

Primary Outcome Measure

Time frame: 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.

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Air Force Medicial University

Other

Registry information

Official study title

A Randomized Controlled Study of Mesenchymal Stem Cells in the Treatment of Chronic Kidney Diseases

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Nov 21, 2025
Registry last updated: Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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