Cranial Reconstruction Using Mesenchymal Stromal Cells and Resorbable Biomaterials

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 evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01742260
Recruitment Status : Unknown
Verified June 2015 by R.P.Herrmann, Royal Perth Hospital.
Recruitment status was:  Recruiting
First Posted : December 5, 2012
Last Update Posted : June 9, 2015
Information provided by (Responsible Party):
R.P.Herrmann, Royal Perth Hospital

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.


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.

Condition or disease Intervention/treatment Phase
Surgically-Created Resection Cavity Procedure: Repair of cranial defects by tissue engineering Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study to Demonstrate Safety and Feasibility of Cranial Reconstruction Using Mesenchymal Stromal Cells and Resorbable Biomaterials
Study Start Date : July 2013
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Repair of cranial defect
Repair of cranial defects by tissue engineering
Procedure: Repair of cranial defects by tissue engineering
Repair of defect using mesenchymal stromal cells seeded between moulded bioceramic plates

Primary Outcome Measures :
  1. Failure of cranioplasty implant [ Time Frame: 12 months ]
    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.

Secondary Outcome Measures :
  1. Quantitative bone density of the tissue engineered construct and adjacent bone from CT scan at 12 months. [ Time Frame: 12 months ]
  2. Assessment of cosmesis by photography [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01742260

Contact: Stephen Honeybul, MD 61893463333

Australia, Western Australia
Royal Perth Hospital Recruiting
Perth, Western Australia, Australia, 6000
Contact: Stephen Honeybul, MD   
Principal Investigator: Stephen Honeybul, MD         
Sponsors and Collaborators
Principal Investigator: Stephen Honeybul, MD Royal Perth Hospital

Responsible Party: R.P.Herrmann, Director, Cell and Tissue Therapies, Western Australia, Royal Perth Hospital Identifier: NCT01742260     History of Changes
Other Study ID Numbers: 2012/047
2012/022238 ( Other Identifier: Aust Govt Dept of Health and Ageing )
First Posted: December 5, 2012    Key Record Dates
Last Update Posted: June 9, 2015
Last Verified: June 2015

Keywords provided by R.P.Herrmann, Royal Perth Hospital:
Mesenchymal stromal cells
Bioceramic polymer