NCT03460223

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2018

Typical duration for phase_1

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 9, 2018

Completed
23 days until next milestone

Study Start

First participant enrolled

April 1, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

March 9, 2018

Status Verified

March 1, 2018

Enrollment Period

1.9 years

First QC Date

February 23, 2018

Last Update Submit

March 4, 2018

Conditions

Renal Cirrhosis

Outcome Measures

Primary Outcomes (5)

  • BUN

    The evaluation of serum levels of BUN

    24 months

  • Cr

    The evaluation of serum levels of Cr

    24 months

  • eGFR

    The evaluation of serum levels of eGFR

    24 months

  • Cystatin C

    The evaluation of serum levels of Cystatin C

    24 months

  • Urine protein

    The evaluation of serum levels of Urine protein

    24 months

Secondary Outcomes (10)

  • Hb

    24 months

  • Hct

    24 months

  • Ca

    24 months

  • P

    24 months

  • ALT

    24 months

  • +5 more secondary outcomes

Other Outcomes (1)

  • Evaluation of renal fibrosis

    24 months

Study Arms (1)

Conventional plus MSC treatment

EXPERIMENTAL
Biological: MSC

Interventions

MSCBIOLOGICAL

conventional plus MSC or placebo treatment

Conventional plus MSC treatment

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent.
  • Glomerular sclerosis ratio ≤ 50%.
  • Renal tubulointerstitial fibrosis ratio ≤ 50%.
  • Negative pregnancy test.
  • Moderately active disease under standard treatment.

You may not qualify if:

  • \. Severe infection and cardiovascular disease, shock, secondary liver disease and malignant tumor.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Jinhai Tang, M.D, PH.D

    Nanjing Medical University

    STUDY CHAIR

Central Study Contacts

Ling Lu, M.D, PH.D

CONTACT

86-025-68136053lvling@njmu.edu.cn

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 23, 2018

First Posted

March 9, 2018

Study Start

April 1, 2018

Primary Completion

March 1, 2020

Study Completion

September 1, 2020

Last Updated

March 9, 2018

Record last verified: 2018-03