Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000727640
Ethics application status
Approved
Date submitted
11/11/2005
Date registered
11/11/2005
Date last updated
20/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Angiogenesis II-Safety and feasibility of autologous mesenchymal precursor cells (MPCs) in chronic myocardial ischaemia.
Scientific title
Angiogenesis II-Safety and feasibility of autologous mesenchymal precursor cells (MPCs) in chronic myocardial ischaemia.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
End stage Ischaemic heart disease 879 0
Condition category
Condition code
Cardiovascular 947 947 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Left ventericular electromechanical mapping and adminsitration of MPCs
Intervention code [1] 756 0
Treatment: Other
Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 1245 0
The primary objective is to assess safety of autologous MPCs in the treatment of end stage ischaemic heart disease.
Timepoint [1] 1245 0
Secondary outcome [1] 2265 0
To demsontrate whether there is an improvement in quality of life, angina score, and a reduction in sublingual nitroglycerine tablet consumption and hospitisations.
Timepoint [1] 2265 0

Eligibility
Key inclusion criteria
Canadian Cardiologic Society (CCS) Angina Scale class III or IV. Attempted best medical therapy including long acting nitrates, beta-blockers, and calcium channel blockers. Doses of each medication should be increased until haemodynamic consequences (bradycardia or hypotension) or intolerable drug-related side effects. Clinical signs and symptoms of significant ischaemia with reversible myocardial ischaemia on perfusion imaging. Subject must be able to complete a minimum of 3 minutes but no more than 10 minutes of Modified Bruce protocol.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unprotected left main coronary artery disease >50%. Unstable angina pectoris (labile ECG changes) or a change in anti - anginal medication within the last three weeks. Myocardial infarction (Q wave or non-Q wave) and cerebrovascular events within the last three months. Left ventricular (LV) thrombus. Severe peripheral vascular disease precluding femoral artery access. Aortic stenosis that prohibited catheter access to the LV. De - compensated heart failure and/ or severe LV dysfunction (ejection fraction <30%). Hypertrophic or restrictive cardiomyopathy.

Study design
Purpose of the study
Treatment
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
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/11/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1044 0
Commercial sector/Industry
Name [1] 1044 0
Mesoblast
Country [1] 1044 0
Australia
Primary sponsor type
University
Name
Mesoblast
Address
Country
Australia
Secondary sponsor category [1] 906 0
None
Name [1] 906 0
None
Address [1] 906 0
Country [1] 906 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2346 0
John Hunter Hospital
Ethics committee address [1] 2346 0
Ethics committee country [1] 2346 0
Australia
Date submitted for ethics approval [1] 2346 0
Approval date [1] 2346 0
Ethics approval number [1] 2346 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36362 0
Address 36362 0
Country 36362 0
Phone 36362 0
Fax 36362 0
Email 36362 0
Contact person for public queries
Name 9945 0
Mr Paul Rennie
Address 9945 0
Mesoblast
Level 39
55 Collins Street
Melbourne VIC 3000
Country 9945 0
Australia
Phone 9945 0
+61 3 96396036
Fax 9945 0
+61 3 96396030
Email 9945 0
paul.rennie@mesoblast.com
Contact person for scientific queries
Name 873 0
Tamara Lewis
Address 873 0
Mesoblast
Level 39
55 Collins Street
Melbourne VIC 3000
Country 873 0
Australia
Phone 873 0
+61 3 96396036
Fax 873 0
+61 3 96396030
Email 873 0
tamara.lewis@mesoblast.com

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.