Cranial Reconstruction Using Mesenchymal Stromal Cells and Resorbable Biomaterials
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|ClinicalTrials.gov 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
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.
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)|
|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|
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
- 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.
- Quantitative bone density of the tissue engineered construct and adjacent bone from CT scan at 12 months. [ Time Frame: 12 months ]
- Assessment of cosmesis by photography [ Time Frame: 12 months ]
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 ClinicalTrials.gov identifier (NCT number): NCT01742260
|Contact: Stephen Honeybul, MDfirstname.lastname@example.org|
|Australia, Western Australia|
|Royal Perth Hospital||Recruiting|
|Perth, Western Australia, Australia, 6000|
|Contact: Stephen Honeybul, MD email@example.com|
|Principal Investigator: Stephen Honeybul, MD|
|Principal Investigator:||Stephen Honeybul, MD||Royal Perth Hospital|