Trial Review

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.


With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.


Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements.
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12605000051640
Ethics application status
Approved
Date submitted
14/07/2005
Date registered
27/07/2005
Date last updated
20/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A safety study of autologous mesenchymal precursor cells (MPCs) in the management of delayed healing tibial fractures requiring secondary surgical intervention to promote fracture union.
Scientific title
A safety study of autologous mesenchymal precursor cells in the management of delayed healing tibial fractures requiring secondary surgical intervention to promote fracture union.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Delayed or non-union tibial fracture 122 0
Condition category
Condition code
Musculoskeletal 137 137 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Surgery and administration of MPCs
Intervention code [1] 24 0
Treatment: Other
Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 173 0
To assess safety of the autologous MPCs in the treatment of delayed or non-union tibial shaft fractures.
Timepoint [1] 173 0
Secondary outcome [1] 380 0
To demonstrate fracture healing is similar or better to than the standard core intervention for delayed or non-union tibial fractures, i.e. autograft or allograft. adminstration of MPCs.
Timepoint [1] 380 0

Eligibility
Key inclusion criteria
A tibial fracture that is either delayed or a non-union that is classified according to the Association of Osteosynthesis as either 42-A, 42-B or 42-C
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
A wound associated with the fracture that is classified according to the Gustilo Anderson Classification System as a IIIC

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
3/08/2006
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] 190 0
Commercial sector/Industry
Name [1] 190 0
Mesoblast
Country [1] 190 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Mesoblast
Address
Country
Australia
Secondary sponsor category [1] 141 0
None
Name [1] 141 0
None
Address [1] 141 0
Country [1] 141 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 35313 0
Address 35313 0
Country 35313 0
Phone 35313 0
Fax 35313 0
Email 35313 0
Contact person for public queries
Name 9213 0
Mr Paul Rennie
Address 9213 0
Mesoblast Level 39 55 Collins Street Melbourne VIC 3000
Country 9213 0
Australia
Phone 9213 0
+61 3 96396037
Fax 9213 0
Email 9213 0
[email protected]
Contact person for scientific queries
Name 141 0
Tamara Lewis
Address 141 0
Mesoblast Level 39 55 Collins Street Melbourne VIC 3000
Country 141 0
Australia
Phone 141 0
+61 3 96396037
Fax 141 0
Email 141 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.