drugset / Trial / NCT04125329
Umbilical Cord Mesenchymal Stem Cells Therapy for Diabetic Nephropathy
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | human umbilical cord mesenchymal stem cells | Cell therapy | 1e+06 cells/kg | Intravenous |