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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01742260
Registration number
NCT01742260
Ethics application status
Date submitted
3/12/2012
Date registered
5/12/2012
Date last updated
9/06/2015
Titles & IDs
Public title
Cranial Reconstruction Using Mesenchymal Stromal Cells and Resorbable Biomaterials
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Scientific title
A Pilot Study to Demonstrate Safety and Feasibility of Cranial Reconstruction Using Mesenchymal Stromal Cells and Resorbable Biomaterials
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Secondary ID [1]
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2012/022238
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Secondary ID [2]
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2012/047
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Surgically-Created Resection Cavity
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Surgery - Repair of cranial defects by tissue engineering
Experimental: Repair of cranial defect - Repair of cranial defects by tissue engineering
Treatment: Surgery: Repair of cranial defects by tissue engineering
Repair of defect using mesenchymal stromal cells seeded between moulded bioceramic plates
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Intervention code [1]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Failure of cranioplasty implant
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Assessment method [1]
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The primary outcome measures will be failure of the tissue engineered construct such that it requires removal (due to infection, resorption, dislodgement or cosmetic failure), as well as any significant adverse events attributable to treatment allocation.
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Timepoint [1]
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12 months
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Secondary outcome [1]
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Quantitative bone density of the tissue engineered construct and adjacent bone from CT scan at 12 months.
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Assessment method [1]
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Timepoint [1]
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12 months
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Secondary outcome [2]
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Assessment of cosmesis by photography
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Assessment method [2]
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Timepoint [2]
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12 months
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Eligibility
Key inclusion criteria
* All adult patients (age > 18 years) who have had a decompressive craniectomy, with a defect size of less than 80 mm in diameter.
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Minimum age
18
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Patients who have had a previous cranial infection
* Patients with a penetrating bone injury
* Positive bone marrow aspirate on testing for microcontamination
* Positive testing for infectious disease
* Cranial void size of larger than 80mm
* Patients who have neurocognitive difficulties and are as such unable to provide informed consent
* Failure to sign informed consent
* Pregnant or breastfeeding females
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
UNKNOWN
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/07/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2017
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Actual
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Sample size
Target
10
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
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Royal Perth Hospital - Perth
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Recruitment postcode(s) [1]
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6000 - Perth
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Funding & Sponsors
Primary sponsor type
Other
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Name
R.P.Herrmann
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Formal study hypothesis: Cranial reconstruction using mesenchymal stromal cells and resorbable biomaterials, will result in the patient producing their own bone to fill the void which will reduce the risk of infection and resorption, lead to a better cosmetic result and obviate any long term consequence of having a synthetic material in vivo. Introduction: There are several reasons that parts of the skull may need to be removed: * After trauma to relieve brain swelling * During brain surgery (for brain cancer) * After trauma where the bone is so badly fractured/fragmented it needs to be removed. In all but the last case the bone flap is temporarily stored in a freezer and once the brain swelling has subsided it is reinserted. This procedure is called "autologous cranioplasty"; autologous, because it originally came from the patient and cranioplasty, referring to the repair. Although this is a straightforward procedure, there are a number of complications including infection and bone resorption that can occur. This study: Stromal cells have a proven ability to aid in bony healing. Furthermore stromal cells on a ceramic framework encased in a plastic scaffold have been shown in a small clinical trial to lead to healing of skull defects. In the present study, it is proposed to add stromal cells from a suitable donor to medical grade ceramic granules, place them in between specially moulded plastic scaffolds and insert the sandwich into the skull. Both the ceramic and plastic materials are medical grade and commonly used in reconstructive surgery, the ceramic for packing into bony defects due to trauma or removal of cancer and the polymer in bony reconstruction. Both materials are approved by the TGA. They are designed to dissolve away over time as the body's own blood vessels and cells populate the sandwich and create the patient's new bone. It has been proven that without the encouragement of the cells and temporary scaffold materials, a hole in the skull will not heal. Given the incidence of bone resorption/infection and metal plate infection using traditional methods, it would seem prudent to provide a construct that will allow controlled replacement with the patient's own bone, thus negating any adverse long-term complications with synthetic materials that remain for life.
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Trial website
https://clinicaltrials.gov/study/NCT01742260
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Stephen Honeybul, MD
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Address
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Royal Perth Hospital
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Stephen Honeybul, MD
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Address
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Country
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Phone
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61893463333
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Fax
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Email
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[email protected]
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Contact person for scientific queries
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
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT01742260
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