Clinical trial NCT05512988: Human Umbilical Cord Mesenchymal Stem Cell(UC-MSC)Delayed Renal Chronic Kidney Disease(CKD3、4 )
Official title: A Randomized, Double-blind, Controlled Clinical Study of Human Umbilical Cord Mesenchymal Stem Cell(UC-MSC)Delayed Renal Chronic Kidney Disease(CKD3、4 )
Conditions: Chronic Kidney Diseases
Summary: The chronic kidney disease is caused by renal structural and functional impairment for more than 3 months due to various causes, including normal and abnormal glomerular filtration rate (GFR), abnormal blood, urine, and imaging findings, or an unexplained decline in GFR (<60 ml/min). Recent years, the incidence of chronic kidney disease has increased year by year worldwide, the incidence of CKD is 8% to 16% in the world's total population. chronic kidney disease has become an important public health problem in China and even the world.
Summarizing the basic and clinical studies at home and abroad, inflammatory factors such as inflammatory chemokines, cytokines, and reactive oxygen species interact with fibrosis factors such as mesangial cells, fibroblasts, and fibroblast activation, which are the root causes of the progression of CKD and the formation of tubular interstitial fibrosis and glomerular sclerosis and developing into end-stage renal disease.
Current treatments for chronic kidney disease are very limited, and to be precise, there is currently no cure for chronic kidney disease, nor is there a proven way to improve the kidneys survive after acute kidney injury (AKI). The progression of the disease itself can only be delayed as much as possible by changing the diet, controlling related complications with oral medications (such as hypertension, hyperlipidemia, nephropathy, etc.), and actively controlling blood glucose and glycosylated hemoglobin levels in patients with diabetes. For patients with stage CKD5 and more severe, renal replacement therapy is recommended, including hemodialysis and peritoneal dialysis, but there are many complications in both dialysis methods, such as narrowing of the internal fistula, occlusion, catheter infection, peritonitis, etc. Kidney transplantation may be considered when economic conditions permit and there is a matching kidney source, but kidney transplant surgery is riskier. The above treatment methods have brought a heavy burden to patients and social medicine. In order to seek innovative and effective strategies to cultivate the limited regenerative capacity of the kidneys and reverse renal fibrosis, the mesenchymal stem cells (MSCs) with tissue regenerative potential and immunomodulatory functions have brought new ideas and hopes for the prevention and treatment of chronic kidney disease.
Interventions:
description: Usage: The stem cell preparation in this study is used intravenously in the elbow.<br/>Dose: The dose of stem cell injection in this clinical study is set at 1×10^6/Kg/time per injection, and the injection frequency is 2 weeks/time.<br/>Duration: 2 injections per trial group for the entire duration of the course, with a total dose of 2×10^6/Kg/person.
name: UC-MSC
type: Biological
description: Usage: The saline solution in this study is used intravenously in the elbow.<br/>Dose: The dose of saline solution in this clinical study is set at 250ml/time per injection, and the injection frequency is 2 weeks/time.<br/>Duration: 2 injections per person for the entire duration of the course
name: Saline solution
type: Biological
Study arms:
design_group_description: MSCs Participants will receive HUC-MSCs
design_group_title: Experimental
design_group_type: Experimental
design_group_description: Comparator participants will receive saline solution
design_group_title: Comparator
design_group_type: Placebo Comparator
Drug name mappings:
name: Human Umbilical Cord Mesenchymal Stem Cells(Zhongyuan Union Stem Cell Bioengineering Co., Ltd.)
lang: EN