NCT04562025

Clinical Research of UC-MSCs in the Treatment of Diabetic Nephropathy

Clinical Research of Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) in the Treatment of Diabetic Nephropathy

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (estimated)
• Sponsor: Renmin Hospital of Wuhan University · Academic / Other
• Sex: All
• Age: 30 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Diabetic nephropathy (DN) is one of the most serious complications of diabetes and the leading cause of end-stage chronic kidney disease. DN is a refractory disease with low awareness, high incidence, and high disability. The incidence of DN can reach 30 to 40% after 20 years of diabetes, of which 5\~10% of patients will progress to end-stage renal disease, and epidemiological surveys predict that by 2030, DN will become the seventh leading cause of death in the world. Currently, there are no effective drugs for treating DN. This clinical trial is to inspect the safety and efficiency of human umbilical cord mesenchymal stem cells (UC-MSCs) therapy for patients with DN.

Detailed description

Diabetic nephropathy (DN) is one of the most important microvascular complications of diabetes. It is a persistent and refractory disease. There is currently a lack of effective clinical treatments for DN. The basic pathological processes of DN are renal tissue cell damage, apoptosis and continuous increase of inflammatory cytokines induced by early high glucose, which gradually leads to glomerular sclerosis and renal fibrosis. Human umbilical cord mesenchymal stem cells (UC-MSCs), as the "youngest" adult stem cells, have powerful anti-inflammatory functions, stronger differentiation potential, and good safety. They are ideal seed cells for the treatment of DN. At present, studies on a variety of animal models of DN have shown that mesenchymal stem cell transplantation can delay the progression of DN and have a certain repair effect on damaged kidney tissue and renal function. Our previous preclinical study showed that UC-MSCs effectively improved the renal function, inhibited inflammation and fibrosis, and prevented its progression in a rat model of diabetes-induced chronic renal injury. Some autologous or allogeneic mesenchymal stem cells have been carried out abroad treatment of chronic kidney disease caused by various reasons, including clinical trials of DN, phase I/II test results did not show obvious adverse reactions related to stem cell therapy, and can improve the patient's renal function and quality of life to a certain extent. The purpose of this study is to investigate efficiency and safety of UC-MSCs in treating DN patients. This trial will recruit 38 patients. 19 patients received the treatment of conventional treatment + equal volume normal saline containing 1% human albumin (placebo group) were used as control group; conventional treatment + 1\*10E6 UC-MSCs/kg body weight (experimental group) for intravenous infusion (once a week, 3 times in total) to treat 19 patients with DN (by unified standard inclusion), and subjects will be followed a total of 48 weeks from time of initial cell treatment.

Conditions

• Diabetic Nephropathy

Interventions

Type	Name	Description
DRUG	UC-MSCs	3 times of UC-MSCs (1\*10E6 UC-MSCs/kg body weight/100mL saline containing 1% human albumin intravenously at week 1,week 2, week 3).
DRUG	Placebo	3 times of cell-free stem cell suspension (saline containing 1% human albumin/100mL intravenously at week 1, week 2, week 3).

Timeline

• Start date: 2020-09-25
• Primary completion: 2021-09-25
• Completion: 2021-12-31
• First posted: 2020-09-24
• Last updated: 2020-09-24

Locations

1 site across 1 country: China