Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000678594
Ethics application status
Approved
Date submitted
27/05/2015
Date registered
30/06/2015
Date last updated
30/06/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Mesenchymal Stem Cells (MSC) for the amelioration of ischaemia-reperfusion injury (IRI) after deceased donor renal transplantation, a phase 1 pilot study
Scientific title
Mesenchymal Stem Cells to prevent ischaemia reperfusion injury in deceased donor renal transplant recipients
Secondary ID [1] 286820 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ischaemia reperfusion injury 295192 0
Kidney Transplantation 295193 0
Condition category
Condition code
Renal and Urogenital 295443 295443 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Infusion of peripheral IV third party allogeneic Mesenchymal Stem Cells 2 x 10 ^6 MSC/kg at reperfusion of deceased donor kidney and at 7 days post reperfusion.
Intervention code [1] 291978 0
Treatment: Other
Comparator / control treatment
Phase 1 pilot study- controls receiving deceased donor kidneys in the period 1.1.2014 - 1.6.2015.
Control group
Historical

Outcomes
Primary outcome [1] 295176 0
Safety and tolerability as determined by clinical events, infusion reactions and immunogenicity measured by Luminex SAB.
Timepoint [1] 295176 0
1 year post renal transplantation.
Primary outcome [2] 295211 0
Graft function (estimated glomerular filtration rate eGFR)
Timepoint [2] 295211 0
1 year post renal transplantation
Primary outcome [3] 295212 0
Renal Allograft Rejection episodes proven by renal biopsy
Timepoint [3] 295212 0
1 year post renal transplantation
Secondary outcome [1] 314948 0
Immunogenicity- HLA antibody measured by Lumniex Single Antigen Beads against third party Donor
Timepoint [1] 314948 0
1 year post renal transplantation

Eligibility
Key inclusion criteria
Adult Deceased Donor kidney recipients
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Live Kidney Donor Recipients

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/09/2014
Actual
29/10/2014
Date of last participant enrolment
Anticipated
1/10/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 3847 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 9732 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 291366 0
Charities/Societies/Foundations
Name [1] 291366 0
Transplant Society of Australia and New Zealand (TSANZ)-AMGEN 2013 Innovation Grant
Country [1] 291366 0
Australia
Primary sponsor type
Hospital
Name
Royal Perth Hospital
Address
GPO Box X2213
Perth WA 6847
Country
Australia
Secondary sponsor category [1] 290044 0
Other Collaborative groups
Name [1] 290044 0
Cell and Tissue Therapies WA
Address [1] 290044 0
c/o Royal Perth Hospital
GPO Box X2213
Perth WA 6847
Country [1] 290044 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292924 0
Royal Perth Hospital
Ethics committee address [1] 292924 0
Royal Perth Hospital
GPO Box X2213
Perth WA 6847
Ethics committee country [1] 292924 0
Australia
Date submitted for ethics approval [1] 292924 0
01/06/2014
Approval date [1] 292924 0
01/08/2014
Ethics approval number [1] 292924 0
RPH 2014-009

Summary
Brief summary
In performing a renal transplant, the time spent by the graft outside the body and cooled on ice (non-perfused) is critical to its future functional capacity. With deceased donor transplants, this may be many hours and there is damage caused to the cells of the kidney by the lack of oxygenated bood suppy, which is called ischaemia. On connection of the donor renal atery to the intended recipients leg artery, blood flow is suddenly restored and the kidney is rewarmed or reperfused. Reperfusion itself is associated with further damage caused by the complex changes on blood vessels and immunological response following the period of ischaemia; the ischaemia-reperfusion injury (IRI). This may lead to delayed function of the kidney, during which the kidney undegoes repair. Changes associated with its recovery may include those that cause injury and scarring and lead to significantly worse renal function in the longer term, causing premature graft senescence and loss. There are currently few effective strategies to reduce this damaging response other than minimsation of cold ischaemia time. Many animal studies have shown that the infusion of mesenchymal stromal cells (MSC) to the recipient lessens the injury associated with IRI and allows earlier short term and better long term kidney function.
We propose to use third party normal (non-immunogenic) MSC at the time of and 7 days following reperfusion of a cold stored kidney, in order to lessen this damage in a pilot study of 10 patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 57638 0
Dr Ashley Irish
Address 57638 0
Department of Nephrology
Fiona Stanley Hospital
Murdoch Drive
Murdoch WA 6150
Country 57638 0
Australia
Phone 57638 0
61 8 61522222
Fax 57638 0
Email 57638 0
[email protected]
Contact person for public queries
Name 57639 0
Ashley Irish
Address 57639 0
Department of Nephrology
Fiona Stanley Hospital
Murdoch Drive
Murdoch WA 6150
Country 57639 0
Australia
Phone 57639 0
61 8 61522222
Fax 57639 0
Email 57639 0
[email protected]
Contact person for scientific queries
Name 57640 0
Marian Sturm
Address 57640 0
CTTWA
B Block
GPO Box X2213
Royal Perth Hospital
Perth WA 6847
Australia
Country 57640 0
Australia
Phone 57640 0
61 8 9224 1987
Fax 57640 0
Email 57640 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.