Mesenchymal Stem Cell Transplantation in the Treatment of... | NCT03585855

Studies
Mesenchymal Stem Cell Transplantation in the Treatment of Chronic Antibody Mediated Kidney Graft Rejection (ABMR)

NCT03585855

Sponsor

University Medical Centre Ljubljana

Status

Terminated

Last Update Posted

Jul 25, 2019Actual

Enrollment

4Actual

Phase

Not Applicable

Conditions

Interventional

Interventions

MSC transplantation

Countries

Slovenia

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

Jul 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Safety reasons

Expanded Access Info

Start Date

Jan 1, 2019Actual

Primary Completion Date

Jul 23, 2019Actual

Completion Date

Jul 23, 2019Actual

First Submitted Date

Jun 25, 2018

First Submission Date that Met QC Criteria

Jul 9, 2018

First Posted Date

Jul 13, 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

Jul 24, 2019

Last Update Posted Date

Jul 25, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Veceric-Haler Zeljka, Principal investigator, University Medical Centre LjubljanaPrincipal Investigator

Lead Sponsor

University Medical Centre LjubljanaOTHER

Collaborators

Name	Class
Slovenian Research Agency	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

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

Transplant rejection is one of the biggest limitations in renal transplant procedures, where the kidney can undergo an acute, late acute, or chronic transplant rejection. With the advancement in transplantation protocols, acute survival of renal transplants has improved, but long-term survival is still unsatisfactory, as most of the renal transplants develop chronic graft rejection. Unfortunately, there is little the investigators know when it comes to improving long-term survival of renal transplants. Mesenchymal stem cells (MSC) have been shown to have immunosuppressive and repairing properties. The purpose of this study is to find out whether MSC in combination with standard therapy of antibody mediated rejection (ABMR) are more effective in preventing organ deterioration and maintaining kidney function.

Detailed Description

Participants will be assigned to receive the full immunosuppressive therapy indicated to treat chronic ABMR (including plasmapheresis (PF) 7x, intravenous immune globulins 100 mg/kg 7x, corticosteroid) and MSC infusions (2x106cells/kg bw after PF) (Group 1) and be compared to historic controls according to "propensity score matching" (treated with immunosuppressive therapy alone (Group 2)). Patients will undergo MSC infusions at the start of the study after each PF. One year post- infusions, patients will be evaluated and undergo kidney biopsies. Blood collection will occur at regular intervals, serum creatinine and the estimated creatinine clearance will be monthly recorded. The transplanted kidney function and morphology (US Doppler) will be evaluated.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

4Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Historic control	No Intervention	historic cohort of patients with ABMR treated with standard of care therapy
MSC transplantation	Experimental	patients with ABMR treated with MSC transplantation	Other: MSC transplantation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MSC transplantation	Other	MSC transplantation: patients with ABMR treated with MSC transplantation	MSC transplantation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety of MSC transplantation as assessed by adverse events according to CTCAE Version 5Estimated glomerular filtration rate (eGFR)	Adverse events according to CTCAE Version 5	12 months

Secondary Outcomes

Measure	Description	Time Frame
Estimated glomerular filtration rate (eGFR)	eGFR at up to 12 months post MSC transplantation	12 months
Graft survival rate	Graft survival rate at 12 months post MSC transplantation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Recipients of a renal allograft, male and female patients age >18
The eGF>20 ml/min/1.73 m2,
Renal biopsy Criteria: chronic active ABMR.
Written informed consent, compliant with local regulations.

Exclusion Criteria:

Recipients of multiple organs.
Pregnant women.
Malignant disease in last 5 years
Active autoimmune disease
Active infection including hepatitis B, hepatitis C, HIV, or tuberculosis
Evidence of congestive cardiac failure and/or acute coronary syndrome in past 6 months.
Evidence of liver disease
Inadequate compliance to treatment.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Željka Večerić-Haler, MDPhD	assist.prof.Željka Večerić-Haler, MDPhD	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Medical Centre Ljubljana		Ljubljana		1000	Slovenia

IPD Sharing Statement Module

Plan to Share IPD

Description

12 months

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided