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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03460223
Recruitment Status : Not yet recruiting
First Posted : March 9, 2018
Last Update Posted : March 9, 2018
Sponsor:
Information provided by (Responsible Party):
Ling Lu, Nanjing Medical University

Tracking Information
First Submitted Date  ICMJE February 23, 2018
First Posted Date  ICMJE March 9, 2018
Last Update Posted Date March 9, 2018
Estimated Study Start Date  ICMJE April 1, 2018
Estimated Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 4, 2018)
  • BUN [ Time Frame: 24 months ]
    The evaluation of serum levels of BUN
  • Cr [ Time Frame: 24 months ]
    The evaluation of serum levels of Cr
  • eGFR [ Time Frame: 24 months ]
    The evaluation of serum levels of eGFR
  • Cystatin C [ Time Frame: 24 months ]
    The evaluation of serum levels of Cystatin C
  • Urine protein [ Time Frame: 24 months ]
    The evaluation of serum levels of Urine protein
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 4, 2018)
  • Hb [ Time Frame: 24 months ]
    The evaluation of serum levels of Hb
  • Hct [ Time Frame: 24 months ]
    The evaluation of serum levels of Hct
  • Ca [ Time Frame: 24 months ]
    The evaluation of serum levels of Ca
  • P [ Time Frame: 24 months ]
    The evaluation of serum levels of P
  • ALT [ Time Frame: 24 months ]
    The evaluation of serum levels of ALT
  • PTH [ Time Frame: 24 months ]
    The evaluation of serum levels of PTH
  • VitD [ Time Frame: 24 months ]
    The evaluation of serum levels of VitD
  • ALB [ Time Frame: 24 months ]
    The evaluation of serum levels of ALB
  • TC [ Time Frame: 24 months ]
    The evaluation of serum levels of TC
  • TG [ Time Frame: 24 months ]
    The evaluation of serum levels of TG
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 4, 2018)
Evaluation of renal fibrosis [ Time Frame: 24 months ]
The pathology decrease in grade of renal fibrosis
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Study of Mesenchymal Stem Cell in Treating Kidney Fibrosis
Official Title  ICMJE Phase 1 Clinical Trial Using Mesenchymal Stem Cell as Individualized Medicine to Evaluate the Safety and Efficacy in Kidney Fibrosis
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Renal Cirrhosis
Intervention  ICMJE Biological: MSC
conventional plus MSC or placebo treatment
Study Arms  ICMJE Experimental: Conventional plus MSC treatment
Intervention: Biological: MSC
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 4, 2018)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 1, 2020
Estimated Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Ling Lu, M.D, PH.D 86-025-68136053 lvling@njmu.edu.cn
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03460223
Other Study ID Numbers  ICMJE NJLT006
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ling Lu, Nanjing Medical University
Study Sponsor  ICMJE Nanjing Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Jinhai Tang, M.D, PH.D Nanjing Medical University
PRS Account Nanjing Medical University
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP