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

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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

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.

Condition or disease Intervention/treatment Phase
Renal Cirrhosis Biological: MSC Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Clinical Trial Using Mesenchymal Stem Cell as Individualized Medicine to Evaluate the Safety and Efficacy in Kidney Fibrosis
Estimated Study Start Date : April 1, 2018
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. BUN [ Time Frame: 24 months ]
    The evaluation of serum levels of BUN

  2. Cr [ Time Frame: 24 months ]
    The evaluation of serum levels of Cr

  3. eGFR [ Time Frame: 24 months ]
    The evaluation of serum levels of eGFR

  4. Cystatin C [ Time Frame: 24 months ]
    The evaluation of serum levels of Cystatin C

  5. Urine protein [ Time Frame: 24 months ]
    The evaluation of serum levels of Urine protein


Secondary Outcome Measures :
  1. Hb [ Time Frame: 24 months ]
    The evaluation of serum levels of Hb

  2. Hct [ Time Frame: 24 months ]
    The evaluation of serum levels of Hct

  3. Ca [ Time Frame: 24 months ]
    The evaluation of serum levels of Ca

  4. P [ Time Frame: 24 months ]
    The evaluation of serum levels of P

  5. ALT [ Time Frame: 24 months ]
    The evaluation of serum levels of ALT

  6. PTH [ Time Frame: 24 months ]
    The evaluation of serum levels of PTH

  7. VitD [ Time Frame: 24 months ]
    The evaluation of serum levels of VitD

  8. ALB [ Time Frame: 24 months ]
    The evaluation of serum levels of ALB

  9. TC [ Time Frame: 24 months ]
    The evaluation of serum levels of TC

  10. TG [ Time Frame: 24 months ]
    The evaluation of serum levels of TG


Other Outcome Measures:
  1. Evaluation of renal fibrosis [ Time Frame: 24 months ]
    The pathology decrease in grade of renal fibrosis



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03460223


Contacts
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Contact: Ling Lu, M.D, PH.D 86-025-68136053 lvling@njmu.edu.cn

Sponsors and Collaborators
Nanjing Medical University
Investigators
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Study Chair: Jinhai Tang, M.D, PH.D Nanjing Medical University

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Responsible Party: Ling Lu, Principal Investigator, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT03460223     History of Changes
Other Study ID Numbers: NJLT006
First Posted: March 9, 2018    Key Record Dates
Last Update Posted: March 9, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fibrosis
Pathologic Processes