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

March 4, 2018 updated by: Ling Lu, Nanjing Medical University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Conventional plus MSC treatment
Biological: MSC
conventional plus MSC or placebo treatment

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of renal fibrosis
Time Frame: 24 months
The pathology decrease in grade of renal fibrosis
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2018

Primary Completion (Anticipated)

March 1, 2020

Study Completion (Anticipated)

September 1, 2020

Study Registration Dates

First Submitted

February 23, 2018

First Submitted That Met QC Criteria

March 4, 2018

First Posted (Actual)

March 9, 2018

Study Record Updates

Last Update Posted (Actual)

March 9, 2018

Last Update Submitted That Met QC Criteria

March 4, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NJLT006

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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