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

Primary Purpose

Renal Cirrhosis

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
MSC
Sponsored by
Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Cirrhosis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Conventional plus MSC treatment

    Arm Description

    Outcomes

    Primary Outcome Measures

    BUN
    The evaluation of serum levels of BUN
    Cr
    The evaluation of serum levels of Cr
    eGFR
    The evaluation of serum levels of eGFR
    Cystatin C
    The evaluation of serum levels of Cystatin C
    Urine protein
    The evaluation of serum levels of Urine protein

    Secondary Outcome Measures

    Hb
    The evaluation of serum levels of Hb
    Hct
    The evaluation of serum levels of Hct
    Ca
    The evaluation of serum levels of Ca
    P
    The evaluation of serum levels of P
    ALT
    The evaluation of serum levels of ALT
    PTH
    The evaluation of serum levels of PTH
    VitD
    The evaluation of serum levels of VitD
    ALB
    The evaluation of serum levels of ALB
    TC
    The evaluation of serum levels of TC
    TG
    The evaluation of serum levels of TG

    Full Information

    First Posted
    February 23, 2018
    Last Updated
    March 4, 2018
    Sponsor
    Nanjing Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03460223
    Brief Title
    Safety and Efficacy Study of Mesenchymal Stem Cell in Treating Kidney Fibrosis
    Official Title
    Phase 1 Clinical Trial Using Mesenchymal Stem Cell as Individualized Medicine to Evaluate the Safety and Efficacy in Kidney Fibrosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 1, 2018 (Anticipated)
    Primary Completion Date
    March 1, 2020 (Anticipated)
    Study Completion Date
    September 1, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Nanjing Medical University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Renal Cirrhosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Conventional plus MSC treatment
    Arm Type
    Experimental
    Intervention Type
    Biological
    Intervention Name(s)
    MSC
    Intervention Description
    conventional plus MSC or placebo treatment
    Primary Outcome Measure Information:
    Title
    BUN
    Description
    The evaluation of serum levels of BUN
    Time Frame
    24 months
    Title
    Cr
    Description
    The evaluation of serum levels of Cr
    Time Frame
    24 months
    Title
    eGFR
    Description
    The evaluation of serum levels of eGFR
    Time Frame
    24 months
    Title
    Cystatin C
    Description
    The evaluation of serum levels of Cystatin C
    Time Frame
    24 months
    Title
    Urine protein
    Description
    The evaluation of serum levels of Urine protein
    Time Frame
    24 months
    Secondary Outcome Measure Information:
    Title
    Hb
    Description
    The evaluation of serum levels of Hb
    Time Frame
    24 months
    Title
    Hct
    Description
    The evaluation of serum levels of Hct
    Time Frame
    24 months
    Title
    Ca
    Description
    The evaluation of serum levels of Ca
    Time Frame
    24 months
    Title
    P
    Description
    The evaluation of serum levels of P
    Time Frame
    24 months
    Title
    ALT
    Description
    The evaluation of serum levels of ALT
    Time Frame
    24 months
    Title
    PTH
    Description
    The evaluation of serum levels of PTH
    Time Frame
    24 months
    Title
    VitD
    Description
    The evaluation of serum levels of VitD
    Time Frame
    24 months
    Title
    ALB
    Description
    The evaluation of serum levels of ALB
    Time Frame
    24 months
    Title
    TC
    Description
    The evaluation of serum levels of TC
    Time Frame
    24 months
    Title
    TG
    Description
    The evaluation of serum levels of TG
    Time Frame
    24 months
    Other Pre-specified Outcome Measures:
    Title
    Evaluation of renal fibrosis
    Description
    The pathology decrease in grade of renal fibrosis
    Time Frame
    24 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Written informed consent. Glomerular sclerosis ratio ≤ 50%. Renal tubulointerstitial fibrosis ratio ≤ 50%. Negative pregnancy test. Moderately active disease under standard treatment. Exclusion Criteria: 1. Severe infection and cardiovascular disease, shock, secondary liver disease and malignant tumor.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ling Lu, M.D, PH.D
    Phone
    86-025-68136053
    Email
    lvling@njmu.edu.cn
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jinhai Tang, M.D, PH.D
    Organizational Affiliation
    Nanjing Medical University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

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

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