Safety and Efficacy Study of Mesenchymal Stem Cell in Treating Kidney Fibrosis

Study Overview
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Brief Summary
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In progressive kidney diseases, fibrosis represents the common pathway to end-stage kidney failure. The potential for stem cells to treat kidney failure was recently confirmed. Particularly, mesenchymal stem cell (MSC) has been demonstrated to protect kidney function and alleviating renal injury in these patients. Therefore, the investigators propose a hypothesis that MSCs (MSC) can also improve the disease conditions of kidney fibrosis patients, particularly reducing the decompensated conditions in these patients.

Detailed Description
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Kidney fibrosis represents the common pathway to end-stage kidney failure.The potential for stem cells to treat kidney failure was recently confirmed. In particular, mesenchymal stem cell (MSC) transplantation has been applicated in the clinic for treat several human diseases such as GVHD, kidyney injury and displayed good tolerance and efficiency. The purpose of this study is to learn whether and how MSCs (MSC) can improve the disease conditions in patients with kidney fibrosis. This study will also look at safety in these patients.

Official Title
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Phase 1 Clinical Trial Using Mesenchymal Stem Cell as Individualized Medicine to Evaluate the Safety and Efficacy in Kidney Fibrosis

Conditions
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Renal Cirrhosis

Intervention / Treatment
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* Biological: MSC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent. Glomerular sclerosis ratio ≤ 50%. Renal tubulointerstitial fibrosis ratio ≤ 50%. Negative pregnancy test. Moderately active disease under standard treatment. Exclusion Criteria: 1. Severe infection and cardiovascular disease, shock, secondary liver disease and malignant tumor.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Conventional plus MSC treatment<br> | Biological: MSC<br>* conventional plus MSC or placebo treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BUN | The evaluation of serum levels of BUN | 24 months | 
| Cr | The evaluation of serum levels of Cr | 24 months | 
| eGFR | The evaluation of serum levels of eGFR | 24 months | 
| Cystatin C | The evaluation of serum levels of Cystatin C | 24 months | 
| Urine protein | The evaluation of serum levels of Urine protein | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hb | The evaluation of serum levels of Hb | 24 months | 
| Hct | The evaluation of serum levels of Hct | 24 months | 
| Ca | The evaluation of serum levels of Ca | 24 months | 
| P | The evaluation of serum levels of P | 24 months | 
| ALT | The evaluation of serum levels of ALT | 24 months | 
| PTH | The evaluation of serum levels of PTH | 24 months | 
| VitD | The evaluation of serum levels of VitD | 24 months | 
| ALB | The evaluation of serum levels of ALB | 24 months | 
| TC | The evaluation of serum levels of TC | 24 months | 
| TG | The evaluation of serum levels of TG | 24 months |