ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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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

ACTRN12619000394145

Ethics application status

Approved

Date submitted

21/02/2019

Date registered

12/03/2019

Date last updated

3/12/2020

Date data sharing statement initially provided

12/03/2019

Type of registration

Retrospectively registered

Titles & IDs

Public title

Skull repair using adult stem cells and a dissolving scaffold

Scientific title

Cranial Reconstruction Using Mesenchymal Stromal Cells and Resorbable Biomaterials in adults with a cranial defect.

Secondary ID [1]

NCT01742260

Secondary ID [2]

2012/022238

Secondary ID [3]

2012/047

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Surgically-Created Resection Cavity

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The intervention is cranioplasty.

a) any physical or informational materials used,
Patient Information Sheets (PIS) will be provided to each patient enrolled in the trial.

b) each of the procedures, activities, and/or processes used,
1. Patient consent

2. Stem Cell Collection
• Blood Test
• Bone Marrow Aspirate
• MSC processing
• Delivery of Intervention by Haematologist

3. Insertion of cranioplasty

c) who will deliver the intervention,
Consultant Haematologist with regard to stem cells
Consultant Neurosurgeon with regard to cranioplasty insertion

d) the mode of delivery,
Face to face and in theatre

e) the number of times the intervention will be delivered and over what period of time,
Once at time of theatre.

f) the location/setting where the intervention occurs.
Major Public Hospital

Intervention code [1]

Treatment: Surgery

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Failure of cranioplasty implant - The primary outcome measures will be failure of the tissue engineered construct such that it requires removal ( for example due to infection, resorption, dislodgement or cosmetic failure), as well as any significant adverse events attributable to treatment allocation.

This is a composite outcome

Assessment
Infection: clinical assessment by Neurosurgeon
Resorption: CT scan at 12 most post op radiological assessment
Cosmesis: Assessment by Neurosurgeon at 3months, 6 months and 12months.
Position of plate: CT scan day Post op day 1

Timepoint [1]

12 months

Secondary outcome [1]

Quantitative bone density of the tissue engineered construct and adjacent bone from CT scan at 12 months.

Assessment: CT scan, analysis of Hounsfield units of host bone and of tissue engineered construct

Timepoint [1]

12 months

Secondary outcome [2]

Assessment of cosmesis by photography

Assessment: clinical photography at 3, 6 and 12 months.

Timepoint [2]

12 months

Eligibility

Key inclusion criteria

- All adult patients (age > 18 years) who have a cranial defect that requires reconstruction with a defect size of less than 110 x 180mm.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

- Patients who have had a previous cranial infection

- Positive bone marrow aspirate on testing for microcontamination

- Positive testing for infectious disease

- Patients who have neurocognitive difficulties and are as such unable to provide
informed consent

- Patients with an ongoing intracranial infection following craniotomy

- Pregnant or breastfeeding females

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

Not Applicable

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

Actual

6/02/2019

Date of last participant enrolment

Anticipated

6/02/2021

Actual

Date of last data collection

Anticipated

31/12/2022

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Royal Perth Hospital - Perth

Recruitment hospital [2]

Fiona Stanley Hospital - Murdoch

Recruitment hospital [3]

Sir Charles Gairdner Hospital - Nedlands

Recruitment postcode(s) [1]

6000 - Perth

Recruitment postcode(s) [2]

6150 - Murdoch

Recruitment postcode(s) [3]

6009 - Nedlands

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

WA State Health Research Advisory Council

Address [1]

189 Royal St, Perth WA 6004

Country [1]

Australia

Primary sponsor type

Individual

Name

Stephen Honeybul

Address

Royal Perth Hospital
197 Wellington St Perth WA 6000

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Perth Hospital EC00270

Ethics committee address [1]

Royal Perth Hospital 
197 Wellington St Perth WA 6000

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

04/04/2012

Approval date [1]

14/09/2012

Ethics approval number [1]

Summary

Brief summary

Brief Summary
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, either autologous or allogeneic, to a resorbable ceramic material and insert into the skull. The ceramic is designed to dissolve away over time as the body's own blood vessels and cells populate the construct 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

Trial related presentations / publications

Public notes

The reason for listing the trial on ANZCTR is twofold.  Firstly the person responsible for registering the trial in the US (clinicaltrials.org) retired and then could not login, and despite numerous attempts we were unsuccessful in gaining access . Secondly, we were advised by our ethics committee that it would be appropriate to register the trial with the ANZCTR,

Contacts

Principal investigator

Name

Dr Stephen Honeybul, MD

Address

Royal Perth Hospital
197 Wellington St, Perth WA 6000

Country

Australia

Phone

+61 892242500

Fax

stephen.honeybul@health.wa.gov.au

Contact person for public queries

Name

Alan Kop

Address

Royal Perth Hospital
197 Wellington St, Perth WA 6000

Country

Australia

Phone

+61 892242500

Fax

alan.kop@health.wa.gov.au

Contact person for scientific queries

Name

Alan Kop

Address

Royal Perth Hospital
197 Wellington St, Perth WA 6000

Country

Australia

Phone

+61 892242500

Fax

alan.kop@health.wa.gov.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Need to ensure participant privacy.

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.

Trial Review

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