Mesenchymal Stem Cells for Chronic Kidney Diseases

A Randomized Controlled Study of Mesenchymal Stem Cells in the Treatment of 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Kidney Disease, Chronic; Hypertensive Nephropathy; Diabetic Kidney Disease (DKD)
• Intervention / Treatment: Drug: MSCs; Drug: 0.9% sodium chloride

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Phase 2; Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DKD	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.
Experimental: HN	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.
Placebo Comparator: non-DKD	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.
Placebo Comparator: non-HN	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Outcome Measure	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.	From enrollment to the end of treatment at 12 months

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Air Force Medicial University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 17, 2025
• First Posted (Estimated): November 21, 2025

Study Record Updates

• Last Update Posted (Actual): December 24, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Diabetes Mellitus; Diabetes Complications; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic; Diabetic Nephropathies; Hypertensive Nephropathy; Inorganic Chemicals; Chlorine Compounds; Sodium Compounds; Chlorides; Hydrochloric Acid; Sodium Chloride
• Other Study ID Numbers: KY20242307

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No