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

Nanjing Medical University

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Renal Cirrhosis

Treatments: Biological: MSC

Study type: Interventional

Funder types: Other

Identifiers

NCT03460223

NJLT006

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Conventional plus MSC treatment

Experimental group

Treatment:

Biological: MSC