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Trial registered on ANZCTR


Trial ID
ACTRN12605000051640
Ethics application status
Approved
Date submitted
14/07/2005
Date registered
27/07/2005
Date last updated
9/01/2017
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
Gender
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
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
Address [1] 190 0
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
paul.rennie@mesoblast.com
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
tamara.lewis@mesoblast.com