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

NCT ID: NCT03460223

Last Updated: 2018-03-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-01
• Study Completion Date: 2020-09-01

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.

Conditions

Renal Cirrhosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Conventional plus MSC treatment

Group Type: EXPERIMENTAL

MSC

Intervention Type: BIOLOGICAL

conventional plus MSC or placebo treatment

Interventions

MSC

conventional plus MSC or placebo treatment

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Ling Lu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jinhai Tang, M.D, PH.D

Role: STUDY_CHAIR

Nanjing Medical University

Central Contacts

Ling Lu, M.D, PH.D

Role: CONTACT

lvling@njmu.edu.cn

86-025-68136053

Other Identifiers

NJLT006

Identifier Type: -

Identifier Source: org_study_id