NCT06969807

Safety and Efficacy of Mesenchymal Stromal Cells (Amimestrocel ) in Diabetic Kidney Disease

Clinical Study to Evaluate the Efficacy and Safety of Mesenchymal Stromal Cell (Amimestrocel ) in Patients With Diabetic Kidney Disease

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Chinese PLA General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This trial is to evaluate the efficacy and safety of umbilical cord-derived mesenchymal stromal cells (Amimestrocel ) in study subjects with progressive diabetic kidney disease (DKD), to investigate whether Amimestrocel can improve renal function or proteinuria of DKD patients.

Conditions

• Diabetic Kidney Disease (DKD)

Interventions

Type	Name	Description
DRUG	Amimestrocel	In the first month (day 1, 14, 28): 1×10E6 cells per kilogram. From the 8th to the 24th week (week 8, 12, 16, 20, 24): 1.5×10E6 cells per kilogram.

Timeline

• Start date: 2025-06-09
• Primary completion: 2026-05-15
• Completion: 2028-05-15
• First posted: 2025-05-14
• Last updated: 2026-03-27

Locations

6 sites across 1 country: China