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Trial registered on ANZCTR


Trial ID
ACTRN12611000011987
Ethics application status
Approved
Date submitted
3/05/2010
Date registered
6/01/2011
Date last updated
6/01/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Stem cells for peripheral vascular disease
Scientific title
Double blind, randomised safety and feasibility evaluation of intra-arterial CD34+ cell delivery for severe peripheral arterial disease
Secondary ID [1] 251680 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral vascular (arterial) disease 257275 0
Condition category
Condition code
Cardiovascular 257423 257423 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A single dose CD34 cells (at a dose of 3 × 10^5 CD34+ cells per kilogram of recipient's body weight), delivered by intra-arterial infusion, delivered in 20 mls saline over 20 minutes
Intervention code [1] 256393 0
Treatment: Other
Comparator / control treatment
Intra-arterial saline 20ml, delivered over 20 mins
Control group
Placebo

Outcomes
Primary outcome [1] 258342 0
The primary outcome is the change in ABI (ratio of blood pressure in the arm to ankle). This outcome will be performed by conducting a between groups comparison of the change in ABI from baseline to follow-up.
Timepoint [1] 258342 0
4 weeks and 3 months following randomization
Secondary outcome [1] 264057 0
The secondary outcome is the pain free walk time. Subjects will be asked to walk at 3km/h on a treadmill at 12 degrees inclination until they develop pain in one or both legs. The test will also be stopped by chest pain or arrhythmia.
Timepoint [1] 264057 0
4 weeks and 3 months
Secondary outcome [2] 264089 0
Quality of Life Questionnaire Short Form 36
Timepoint [2] 264089 0
4 weeks and 3 months
Secondary outcome [3] 264090 0
Transcutaneous oxygen tension in toes
Timepoint [3] 264090 0
4 weeks and 3 months

Eligibility
Key inclusion criteria
Inoperable peripheral arterial disease (PAD) with rest pain or non healing ulcer
Minimum age
18 Years
Maximum age
100 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Recent acute coronary disease, severe other life threatening illness

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Current
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256897 0
Government body
Name [1] 256897 0
National Health and Medical Research Council of Australia
Address [1] 256897 0
GPO Box 1421
Canberra ACT 2601
Country [1] 256897 0
Australia
Primary sponsor type
Hospital
Name
Alfred Hospital
Address
Commercial Rd
Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 256181 0
Commercial sector/Industry
Name [1] 256181 0
Mitenyi Biotech
Address [1] 256181 0
2 Eden Park Drive.
North Ryde NSW 2113
Country [1] 256181 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258907 0
Alfred Hospital Research and Ethics Committee
Ethics committee address [1] 258907 0
Ethics committee country [1] 258907 0
Australia
Date submitted for ethics approval [1] 258907 0
26/04/2010
Approval date [1] 258907 0
Ethics approval number [1] 258907 0

Summary
Brief summary
This study seeks to establish whether stem cells can be used to treat patients with poor circlation in their legs.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31116 0
Address 31116 0
Country 31116 0
Phone 31116 0
Fax 31116 0
Email 31116 0
Contact person for public queries
Name 14363 0
Bec Stornebrink
Address 14363 0
Heart Centre
Alfred Hospital
Commercial Rd
Melbourne VIC 3004
Country 14363 0
Australia
Phone 14363 0
+61 3 9076 3263
Fax 14363 0
Email 14363 0
r.stornebrink@alfred.org.au
Contact person for scientific queries
Name 5291 0
Prof David Kaye
Address 5291 0
Heart Centre
Alfred Hospital
Commercial Rd
Melbourne VIC 3004
Country 5291 0
Australia
Phone 5291 0
+61 3 9076 3263
Fax 5291 0
Email 5291 0
david.kaye@baker.edu.au