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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Scientific title
A Pilot Study to Demonstrate Safety and Feasibility of Cranial Reconstruction Using Mesenchymal Stromal Cells and Resorbable Biomaterials
Secondary ID [1] 0 0
2012/022238
Secondary ID [2] 0 0
2012/047
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Surgically-Created Resection Cavity 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Failure of cranioplasty implant
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
Quantitative bone density of the tissue engineered construct and adjacent bone from CT scan at 12 months.
Timepoint [1] 0 0
12 months
Secondary outcome [2] 0 0
Assessment of cosmesis by photography
Timepoint [2] 0 0
12 months

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.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2017
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
6000 - Perth

Funding & Sponsors
Primary sponsor type
Other
Name
R.P.Herrmann
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01742260
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Stephen Honeybul, MD
Address 0 0
Royal Perth Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Stephen Honeybul, MD
Address 0 0
Country 0 0
Phone 0 0
61893463333
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01742260