Cranial Reconstruction Using Mesenchymal Stromal Cells and Resorbable Biomaterials

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Royal Perth Hospital
Sponsor:
Information provided by (Responsible Party):
R.P.Herrmann, Royal Perth Hospital
ClinicalTrials.gov Identifier:
NCT01742260
First received: December 3, 2012
Last updated: July 23, 2014
Last verified: July 2014
  Purpose

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.


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

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Royal Perth Hospital:

Primary Outcome Measures:
  • Failure of cranioplasty implant [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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:
  • Quantitative bone density of the tissue engineered construct and adjacent bone from CT scan at 12 months. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Assessment of cosmesis by photography [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: July 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01742260

Contacts
Contact: Stephen Honeybul, MD 61893463333 stephen.honeybul@health.wa.gov.au

Locations
Australia, Western Australia
Royal Perth Hospital Recruiting
Perth, Western Australia, Australia, 6000
Contact: Stephen Honeybul, MD       stephen.honeybul@health.wa.gov.au   
Principal Investigator: Stephen Honeybul, MD         
Sponsors and Collaborators
R.P.Herrmann
Investigators
Principal Investigator: Stephen Honeybul, MD Royal Perth Hospital
  More Information

No publications provided

Responsible Party: R.P.Herrmann, Director, Cell and Tissue Therapies, Western Australia, Royal Perth Hospital
ClinicalTrials.gov Identifier: NCT01742260     History of Changes
Other Study ID Numbers: 2012/047, 2012/022238
Study First Received: December 3, 2012
Last Updated: July 23, 2014
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Royal Perth Hospital:
Cranioplasty
Mesenchymal stromal cells
Bioceramic polymer

ClinicalTrials.gov processed this record on September 18, 2014