Renal Cirrhosis
Conditions
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.
Interventions
BIOLOGICALMSC
conventional plus MSC or placebo treatment
Sponsors
Nanjing Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. Written informed consent. 2. Glomerular sclerosis ratio ≤ 50%. 3. Renal tubulointerstitial fibrosis ratio ≤ 50%. 4. Negative pregnancy test. 5. Moderately active disease under standard treatment.
Exclusion criteria
1\. Severe infection and cardiovascular disease, shock, secondary liver disease and malignant tumor.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urine protein | 24 months | The evaluation of serum levels of Urine protein |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| TC | 24 months | The evaluation of serum levels of TC |
| TG | 24 months | The evaluation of serum levels of TG |
| ALB | 24 months | The evaluation of serum levels of ALB |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of renal fibrosis | 24 months | The pathology decrease in grade of renal fibrosis |
Contacts
Primary ContactLing Lu, M.D, PH.D
Outcome results
None listed