Two thousand three hundred patients - nearly half of them children - are admitted to UK hospitals each year with full thickness burns. Three hundred of these patients die in hospital from their wounds and many of those that survive require reconstructive surgery over many years. The UK's National Health Service (NHS) spends over £160m each year on burns treatments.
The new project aims to address this problem by developing a cost-effective and scaleable manufacturing process for Avecia's 'allerginaic' wound healing technology that uses adult stem cells to grow new skin that can be stored and be ready immediately to be grafted on to wounds when needed - replacing the much slower and costly 'autologous' method currently used, where a skin sample is grafted from the victim and grown in the laboratory while they have to wait.
"The scaled-up manufacturing of adult stem cells to create new tissue will increase the quality, speed and number of treatments and lower the overall cost per treatment by between five and ten fold," Dr Bo Kara, head of expression and cell science for Avecia, told In-PharmaTechnologist.com.
Avecia's new process involves using adult stem cells derived from the region around the bottom of the hair follicle, called dermal mesenchymal cells, which have the ability to differentiate into a number of cell types, including skin.
They will be grown into skin stem cells in a bioreactor, which are then isolated and attached to a matrix in order to grow sheets of new skin.
"Typically 10 million dermal mesenchymal cells are required to make enough skin for one patient," said Kara.
"The first step in the scale-up process will be to define the media we will require to develop the right cell characteristics. Then we will evaluate and obtain the bioreactor technology we need to make the cells in. Finally we will define the quality attributes of the final product to make sure it has the right biomarkers and the right cell characteristics."
By using adult stem cells, Avecia's new bio-processing technique will also bypass the ethical issues surrounding the use of embryonic stem cells, while creating a more superior skin product, according to Kara.
"Other ethically-derived methods using adult keratinocytes are being used in synthetic skin products already available on the market such as Dermograft and Appligraft, however, these skin products are more expensive to produce and have fewer properties than ours will," said Kara.
"Initial data is showing that our skin product will lead to faster healing and will allow the patient to feel changes in temperature and perhaps even grow new hair through the skin grafts. This is unique to any other product already available."
In addition, the Avecia method will produce the cells in a serum free media, avoiding the use of animal components in the growth media that carry the risk of transmissible spongiform encephalopathy (TSE).
Avecia's partners in the project include the Centre for Stem Cell Discovery & Regenerative Medicine of the UK's Durham University - a recognised world leader in stem cell research; the Blond McIndoe Centre, prominent in plastic and reconstructive surgery; Smith & Nephew - a global specialists in advanced wound management products; and the healthcare-based regional economic development agency, the Centre for Excellence for Life Sciences (CELS).
The project has received half its funding from the UK Government's Department of Trade & Industry (DTI) under the Technology Programme, in recognition of both UK expertise in the field and the challenge of competition from teams in both the US and the Far East. Most of the remaining funding is being provided by Avecia.
At the end of the three-year project, Kara believes the scale up process will be mastered and the product will have completed testing in animal models and will be ready to enter its first clinical trials.