drugset / Trial / NCT04125329

Umbilical Cord Mesenchymal Stem Cells Therapy for Diabetic Nephropathy

NCT04125329

NaSingle-groupOpen-labelTreatment

Summary

This clinical trial assessed the safety of human umbilical cord mesenchymal stem cell therapy in 15 patients with diabetic nephropathy. Fifteen subjects received umbilical cord mesenchymal stem cell therapy 3 times. Approximately 1 × 106/kg of human umbilical cord mesenchymal stem cells were administered by peripheral intravenous infusion once a month .Endpoints:Primary endpoint: Safety and adverse events (safety and tolerability of umbilical cord mesenchymal stem cell therapy within 60 weeks).Secondary endpoint indicators:Efficacy measures: eGFR, urinary albumin-to-creatinine ratio, and percentage changes of 24-h urinary protein quantities from baseline to 60 weeks.

Timeline

Start
2020-04-01
Primary completion
2024-09-01
Completion
2024-09-01

Drugs

EvaluationDrugModalityDoseRoute
Subject human umbilical cord mesenchymal stem cells Cell therapy 1e+06 cells/kg Intravenous