Treatment of Chronic Renal Failure With Adipose Tissue-derived Mesenchymal Stem Cells

Study Overview
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Brief Summary
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To investigate the biological characteristics of adipose tissue-derived mesenchymal stem cells(AMSCs) and its treatment effects on chronic renal failure.

Detailed Description
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This study aims to investigate the biological characteristics of adipose tissue-derived mesenchymal stem cells(AMSCs) and its effect on oxidative stress, inflammation and mitochondrial damage.We intend to use blood oxygen level-dependent magnetic resonance imaging(BOLD-MRI), emission computed tomography(ECT) and enhanced magnetic resonance imaging to monitor renal oxygenation, tissue perfusion and renal function.Ultimately, we evaluate the treatment effects of AMSCs on chronic renal failure through these observations mentioned above.We hope to delay the progression of renal function in patients with chronic renal failure, and save huge social cost for dialysis by these research.

Official Title
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The Biological Characteristics of Adipose Tissue-derived Mesenchymal Stem Cells and Its Role in the Treatment of Chronic Renal Failure

Conditions
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Mesenchymal Stem Cells, Chronic Kidney Diseases, Renal Interstitial Fibrosis

Intervention / Treatment
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* Drug: Treatment group
* Drug: Control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Enroll the chronic renal failure patients without dialysis in the department of nephrology of Affiliated Hospital of Xuzhou Medical University from January 2017 to December 2018. The patients enrolled were not treated with drugs that affect the renal blood flow and oxygen consumption, such as ACEI, ARB, calcium channel blockers, diuretics, vasodilators and other related factors within 2 weeks. Exclusion Criteria: Exclude those patients with diabetes, cardiovascular disease, severe infection, shock, dehydration, abnormal liver function, received glucocorticoid therapy, surgery and emergency dialysis. Eliminate those patients with respiratory disease(such as chronic obstructive pulmonary disease, bronchiectasis, asthma), cardiovascular diseases(such as acute and chronic cardiac insufficiency), blood system diseases (such as aplastic anemia, nutritional anemia and polycythemia vera).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment group<br>Adipose tissue-derived mesenchymal stem cells were used to treat patients with chronic renal failure. | Drug: Treatment group<br>* Adipose tissue-derived mesenchymal stem cells were used to treat patients with chronic renal failure on the basis of conventional treatment.<br>* Other names: Stem cells treatment group;|
| Placebo Comparator: Control group<br>Treatment of chronic renal failure patients with conventional methods. | Drug: Control group<br>* Conventional treatment were used to treat patients with chronic renal failure.<br>* Other names: Conventional treatment group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum creatinine | intravenous blood sampling | after 3 months of adipose tissue-derived mesenchymal stem cells treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glomerular filtration rate | emission computed tomography | after 3 months of adipose tissue-derived mesenchymal stem cells treatment | 
| apparent relaxation rate | blood oxygen level dependent magnetic resonance imaging | after 3 months of adipose tissue-derived mesenchymal stem cells treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adipose Tissue-derived Mesenchymal Stem Cells, Chronic Kidney Diseases