Safety and Efficacy Study of Mesenchymal Stem Cell in Tre... | NCT03460223

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

NCT03460223

Sponsor

Nanjing Medical University

Status

Unknown status

Last Update Posted

Mar 9, 2018Actual

Enrollment

30Estimated

Phase

Phase 1Phase 2

Conditions

Renal Cirrhosis

Interventions

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2018Estimated

Primary Completion Date

Mar 1, 2020Estimated

Completion Date

Sep 1, 2020Estimated

First Submitted Date

Feb 23, 2018

First Submission Date that Met QC Criteria

Mar 4, 2018

First Posted Date

Mar 9, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 4, 2018

Last Update Posted Date

Mar 9, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Conventional plus MSC treatment	Experimental		Biological: MSC

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MSC	Biological	conventional plus MSC or placebo treatment	Conventional plus MSC treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Hb	The evaluation of serum levels of Hb	24 months
Hct	The evaluation of serum levels of Hct	24 months

Other Outcomes

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

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ling Lu, M.D, PH.D	Contact	86-025-68136053		lvling@njmu.edu.cn

Overall Officials

Name	Affiliation	Role
Jinhai Tang, M.D, PH.D	Nanjing Medical University	Study Chair

Locations

Not provided