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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

Scientific title

A Pilot Study to Demonstrate Safety and Feasibility of Cranial Reconstruction Using Mesenchymal Stromal Cells and Resorbable Biomaterials

Secondary ID [1]

2012/022238

Secondary ID [2]

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

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]

Treatment: Surgery

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Failure of cranioplasty implant

Timepoint [1]

12 months

Secondary outcome [1]

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

Timepoint [1]

12 months

Secondary outcome [2]

Assessment of cosmesis by photography

Timepoint [2]

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?

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

Not applicable

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

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Royal Perth Hospital - Perth

Recruitment postcode(s) [1]

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/study/NCT01742260

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Stephen Honeybul, MD

Address

Royal Perth Hospital

Country

Phone

Fax

Contact person for public queries

Name

Stephen Honeybul, MD

Address

Country

Phone

61893463333

Fax

stephen.honeybul@health.wa.gov.au

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

Trial Review

Registering a new trial?

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01742260