NCT07240987

Mesenchymal Stem Cells for Chronic Kidney Diseases

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

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: The First Affiliated Hospital of Air Force Medicial University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Kidney Disease, Chronic
• Diabetic Kidney Disease (DKD)
• Hypertensive Nephropathy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-01-01
• Primary completion: 2027-08-31
• Completion: 2027-08-31
• First posted: 2025-11-21
• Last updated: 2025-12-24