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Not Yet Recruiting PHASE1, PHASE2 INTERVENTIONAL NCT07240987

Mesenchymal Stem Cells for Chronic Kidney Diseases: A Randomized Controlled Trial

View on ClinicalTrials.gov Updated Dec 15, 2025

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

Name: The experimental group will receive an intravenous injection of allogeneic MSCs.The control group will receive a placebo, which is an intravenous infusion of 250 mL of 0.9% sodium chloride injection.
Type: DRUG
Description: All eligible patients will be randomly assigned to the experimental group (MSC group) or the control group (placebo group), while continuing to receive conventional therapy. The experimental group will receive an intravenous injection of allogeneic MSCs at a dose of 1.0\*106/kg. The control group will receive a placebo, which is an intravenous infusion of 250 mL of 0.9% sodium chloride injection, matching the appearance and administration procedure of the MSC infusion..

Primary Outcomes

Measure: Primary Outcome Measure
TimeFrame: From enrollment to the end of treatment at 12 months
Description: 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.

Trial Information

NCT ID

NCT07240987

Status

Not Yet Recruiting

Study Type

INTERVENTIONAL

Phases

PHASE1, PHASE2

Sponsor

The First Affiliated Hospital of Air Force Medicial University

Last Updated

December 15, 2025