A synthetic skin scaffold to treat full thickness wounds Making a difference for patients and carers
make a dermal scaffold we called "Smart Matrix",' says Dr Dye. His team found that this biomaterial
promotes rapid ingress of capillary- forming cells (endothelial cells) — a critical first step in forming new capillaries.
Improving wound healing At this stage, the big question was whether the material would improve wound healing. 'Our proof-of-concept in vivo
evaluations of prototype scaffolds showed that the material vascularised significantly faster, with new blood vessels forming up to 10 times the depth of that seen in clinically used collagen-based material,' says Dr Dye. 'Also, the qualitative histological results indicate improved formation of a neodermis. 'During the last two years we
have gained statistical evidence for accelerated and potentially improved wound healing with the skin scaffold compared with the commercial standard. Importantly, we have seen that blood vessel formation does, indeed, occur very rapidly and extensively within the scaffold. 'We have discovered how to further
accelerate the formation of new blood capillaries, and the overall rate of cell ingrowth, by optimising the physical structure and porosity of the scaffold. This has enabled the material to support a single-stage integration with a split thickness skin graft, regenerating the full- thickness of skin within one week. 'This is important because if it can
be achieved clinically this will reduce the number of surgical operations that patients need to undergo and may reduce the incidence of infection.'
Finding a clinical manufacturer At this point, the scaffold is ready to be turned over to a clinical manufacturer to be produced under strict regulatory controls. Patient trials will follow. Dr Dye has had the initial meetings
with a UK-based manufacturer and RAFT has begun detailed planning on how it will transfer over workbench technology to the company. 'This approach has taken a long time to establish, but we hope that patients will
A processing step in manufacturing the Smart Matrix biomaterial — translation of the process into a clean room environment is the next stage in bringing the product into the clinic.
benefit in the end,' he says. 'The scaffold must be made under the strict regulatory framework for medical products (GMP) which RAFT does not have. We are a research laboratory, not a manufacturing plant. Every aspect of the manufacturing process must be scrutinised — it’s very stringent and very expensive to do.' However, because the Sheffield-based
facility is licensed to manufacture items in the strictest of conditions, the scaffold produced there can be supplied for patient trials anywhere. This will greatly simplify the whole process and hopefully get the scaffold to patients quicker. 'In pre-clinical trials with experimental
wounds, the scaffold has integrated into the wounds exactly as we were hoping it would,' says Dr Dye. 'This provided us with more evidence of the reliability of Smart Matrix in restoring a full-thickness of skin in a single step.'
For more details of the findings of this study visit
www.raft.ac.uk
Author details Dr Julian F Dye is Director of Research (Angiogenesis and Tissue Engineering), RAFT Institute Mount Vernon Hospital. Northwood, UK.
www.woundsinternational.com
7
Editorial and opinion
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