Chronic Kidney Diseases Clinical Trial
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 )
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.
Status | Recruiting |
Enrollment | 44 |
Est. completion date | May 31, 2024 |
Est. primary completion date | April 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Patients with clinical diagnosis of chronic kidney disease (CKD) and stage 3 and stage 4 (GFR 15-60 ml/min) of CKD (American Kidney Disease Foundation stage) - Agree to sign the informed consent form at the same time by means of participation of the pilot group - Age between 18-65 years old Exclusion Criteria: - Patients who are taking immunosuppressants or have been taking them within a month - Patients with a 30% increase in creatinine in the past 3 months and who are about to undergo dialysis - Suffering from severe heart, respiratory insufficiency, viral hepatitis, and sexually transmitted diseases - Hypersensitivity to stem cells themselves or stem cell-related media - Patients with recent bacterial, viral, or fungal infections - Have a history of tumors or are currently suffering from tumor conditions - Pregnant or breastfeeding - Have participated in drug-related clinical trials in the past two months - Any form of substance abuse, mental illness, and other conditions that researchers believe may affect the effectiveness of the test or the patient's physical health |
Country | Name | City | State |
---|---|---|---|
China | Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology | Wuhan | Hubei |
Lead Sponsor | Collaborator |
---|---|
Tongji Hospital | Zhongyuan Xiehe Biological Cell Storage Service (Tianjin) Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of GFR | GFR decrease at 2.5ml/min/year or more from baseline | baseline, 6-month after 2nd treatment, 12-month after 2nd treatment | |
Primary | Incidence of Treatment-Serious Adverse Events as assessed by SPSS 23.0 and Graphpad prism 6 | To observe the incidence of serious adverse events,such as fatal cardiovascular and cerebrovascular disease, tumor, organ failure, severe infection. | Through study completion, an average of 13 months | |
Primary | Number of participants with treatment-related adverse events as assessed by SPSS 23.0 and Graphpad prism 6 | Collecting and comparing the number and severity of participants with skin reactions, fever, infection, allergic reactions, etc. in the two groups. | Through study completion, an average of 13 months | |
Secondary | IgA | Change of humoral immunity after stem cell treatment | 2 weeks after the first treatment, 1 month, 3 months, 6 months and 9 months, 12 months, 18 months, 24 months after the second treatment | |
Secondary | IgG | Change of humoral immunity after stem cell treatment | 2 weeks after the first treatment, 1 month, 3 months, 6 months and 9 months, 12 months, 18 months, 24 months after the second treatment | |
Secondary | IgM | Change of humoral immunity after stem cell treatment | 2 weeks after the first treatment, 1 month, 3 months, 6 months and 9 months, 12 months, 18 months, 24 months after the second treatment | |
Secondary | C3 | Change of humoral immunity after stem cell treatment | 2 weeks after the first treatment, 1 month, 3 months, 6 months and 9 months, 12 months, 18 months, 24 months after the second treatment | |
Secondary | C4 | Change of humoral immunity after stem cell treatment | 2 weeks after the first treatment, 1 month, 3 months, 6 months and 9 months, 12 months, 18 months, 24 months after the second treatment | |
Secondary | CRP | Changes in inflammatory and immunological serologic indicators after stem cell treatment | 2 weeks after the first treatment, 1 month, 3 months, 6 months and 9 months, 12 months, 18 months, 24 months after the second treatment | |
Secondary | IL-6 | Changes in inflammatory and immunological serologic indicators after stem cell treatment | 2 weeks after the first treatment, 1 month, 3 months, 6 months and 9 months, 12 months, 18 months, 24 months after the second treatment | |
Secondary | Peripheral hemolymocyte subsets | Changes in inflammatory and immunological serologic indicators after stem cell treatment | 2 weeks after the first treatment, 1 month, 3 months, 6 months and 9 months, 12 months, 18 months, 24 months after the second treatment | |
Secondary | Urine protein | To observe the change of urine test after stem cell treatment | 2 weeks after the first treatment, 1 month, 3 months, 6 months and 9 months, 12 months, 18 months, 24 months after the second treatment | |
Secondary | Urine RBC | To observe the change of urine test after stem cell treatment | 2 weeks after the first treatment, 1 month, 3 months, 6 months and 9 months, 12 months, 18 months, 24 months after the second treatment | |
Secondary | 24-hour urine protein | To observe the change of urine test after stem cell treatment | 2 weeks after the first treatment, 1 month, 3 months, 6 months and 9 months, 12 months, 18 months, 24 months after the second treatment | |
Secondary | Urine albumin/creatinine | To observe the change of urine test after stem cell treatment | 2 weeks after the first treatment, 1 month, 3 months, 6 months and 9 months, 12 months, 18 months, 24 months after the second treatment | |
Secondary | Electrolytes | The change of electrolytes was detected after treatment | 2 weeks after the first treatment, 1 month, 3 months, 6 months and 9 months, 12 months, 18 months, 24 months after the second treatment | |
Secondary | Hemoglobin | The change of hemoglobin was detected after treatment | 2 weeks after the first treatment, 1 month, 3 months, 6 months and 9 months, 12 months, 18 months, 24 months after the second treatment | |
Secondary | Albumin | The change of albumin was detected after treatment | 2 weeks after the first treatment, 1 month, 3 months, 6 months and 9 months, 12 months, 18 months, 24 months after the second treatment | |
Secondary | Heart ultrasound | To assess the incidence of complications in other organ systems, such as cardiovascular, skeletal, and hematopoietic systems | Baseline, 3 months, 6 months and 9 months, 12 months,18 months, 24 months after the second treatment | |
Secondary | Carotid ultrasound | To assess the incidence of complications in other organ systems, such as cardiovascular, skeletal, and hematopoietic systems | Baseline, 3 months, 6 months and 9 months, 12 months, 18 months, 24 months after the second treatment | |
Secondary | NT-proBNP | To assess the incidence of complications in other organ systems, such as cardiovascular, skeletal, and hematopoietic systems | Baseline, 2nd treatment, 1 months, 3 months, 6 months and 9 months, 12 months, 18 months, 24 months after the second treatment | |
Secondary | iPTH+1,25-VitD3 | To assess the incidence of complications in other organ systems, such as cardiovascular, skeletal, and hematopoietic systems | Baseline, 2nd treatment, 1 months, 3 months, 6 months and 9 months, 12 months, 18 months, 24 months after the second treatment |
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