Safety and Efficacy Study of Mesenchymal Stem Cell in Treating Kidney Fibrosis
- Conditions
- Renal Cirrhosis
- Interventions
- Biological: MSC
- Registration Number
- NCT03460223
- Lead Sponsor
- Nanjing Medical University
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
- Written informed consent.
- Glomerular sclerosis ratio ≤ 50%.
- Renal tubulointerstitial fibrosis ratio ≤ 50%.
- Negative pregnancy test.
- Moderately active disease under standard treatment.
- Severe infection and cardiovascular disease, shock, secondary liver disease and malignant tumor.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Conventional plus MSC treatment MSC -
- Primary Outcome Measures
Name Time Method BUN 24 months The evaluation of serum levels of BUN
Cr 24 months The evaluation of serum levels of Cr
eGFR 24 months The evaluation of serum levels of eGFR
Cystatin C 24 months The evaluation of serum levels of Cystatin C
Urine protein 24 months The evaluation of serum levels of Urine protein
- Secondary Outcome Measures
Name Time Method Hb 24 months The evaluation of serum levels of Hb
Hct 24 months The evaluation of serum levels of Hct
Ca 24 months The evaluation of serum levels of Ca
P 24 months The evaluation of serum levels of P
ALT 24 months The evaluation of serum levels of ALT
PTH 24 months The evaluation of serum levels of PTH
VitD 24 months The evaluation of serum levels of VitD
ALB 24 months The evaluation of serum levels of ALB
TC 24 months The evaluation of serum levels of TC
TG 24 months The evaluation of serum levels of TG