The UK’s first commercial source of cultured skin cells for difficult to manage burns patients
Submitting InstitutionUniversity of Sheffield
Unit of AssessmentElectrical and Electronic Engineering, Metallurgy and Materials
Summary Impact TypeTechnological
Research Subject Area(s)
Medical and Health Sciences: Clinical Sciences
Summary of the impact
Research from the Department of Materials Science and Engineering led to
healthcare impact through treatment of burns patients and those with
chronic non-healing wounds using the culture and expansion of the
patient's own skin cells. This impact was achieved by establishing a
product, MySkin®, as the UK's first and only commercially
available complete service for the culture and delivery of patient's skin
cells. It is now used in 11 out of the UK's 12 major burns units for
patients in danger of death from extensive burns. MySkin®
benefits patients, clinicians and nurses and was Biomedical Product of the
Year in 2008 (see Sky News video (2008) on www.Ilika.com).
The majority of patients with burns injuries or ulcers can be handled
using conventional skin grafting and wound treatments. However, for people
that have over 60% burns, conventional treatments simply do not work. Cell
therapy can be invaluable for patients with extensive full thickness burns
(otherwise vulnerable to bacterial infection, sepsis and death) and many
thousands of patients with chronic ulcers that do not heal with current
best clinical practice.
The research undertaken by Professor Sheila MacNeil's team (University of
Sheffield since 1976) developed a methodology with a sufficient
performance and success rate to make it commercially viable and therefore
clinically useful as a service to health practitioners.
The research arose from her longstanding collaboration with the Sheffield
Burns Unit. This began in 1992 using the (then) best practice methodology
of culturing human skin cells into small sheets for delivery to patients
with extensive burns injuries. They undertook a 10-year clinical audit of
this technique and concluded that it delivered poor performance in meeting
clinical need. In particular these very delicate sheets of cells were
difficult to handle and the success rate with them was poor. Also, it was
very challenging to manage the timing of their production to the needs of
the patients. All of the above explains why this cell therapy approach was
not previously adopted for routine use in Burns Centres or Wound Care
Centres in the UK.
Accordingly, from 1997 onwards MacNeil developed an improved, simpler and
more robust methodology for delivering patient's skin cells from the
laboratory to the patient [R1-6] through collaboration with Professor
Robert Short (a surface science engineer in the Department of Materials
Science & Engineering from 1995-2007). The product MySkin®
was developed through a spinout company, Celltran Ltd, which ran from 2000
The underpinning technology was plasma polymerisation, which was used to
make a surface that was attractive for the attachment of skin cells
(keratinocytes) but not too adhesive so that cells placed in contact with
the patient would readily leave the cell delivery carrier surface and
transfer to the wound bed.
MacNeil's distinctive research contribution was that she led the team
that started with a clinical problem — the need to provide a rapid barrier
for patients who have lost extensive skin due to burns injuries. An
analysis of the current technology was undertaken to provide cultured cell
therapy to restore this barrier and a materials surface engineering
solution was designed. The treatment method was refined through
collaborations that involved the local hospitals with introduction to the
clinic, and then developing MySkin® as the commercially
sustainable product. Importantly, MacNeil provided the evidence base that
supported the clinical adoption of this medical advance.
This work was supported by 14 grants running between 2003 and 2009
amounting to a total of £2,526,702 including EPSRC "Surfaces to enhance
tissue culture of skin" October 1999 to September 2003. £110,922, R.M.
France, S. MacNeil and G.J. Leggett and a Wellcome Catalyst Biomedical
award to CellTran Ltd of £585,000 in September 2002.
References to the research
References that best indicate the quality of the research are indicated
with asterisks (***):
R1*** R.M. France, R.D. Short, R.A. Dawson and S. MacNeil.
Attachment of human keratinocytes to plasma co-polymers of acrylic
acid/octa-1,7-diene and allyl amine/octa- 1,7-diene. Journal of
Materials Chemistry 8 (1998) 37-42. doi: 10.1039/A705098D
R2*** D.B. Haddow, D.A. Steele, R.D. Short, R.A. Dawson and S.
MacNeil. Plasma polymerised surfaces for culture of human keratinocytes
and transfer of cells to an in vitro wound bed model. Journal of
Biomedical Materials Research 64A (2003) 80-87. doi: 10.1002/jbm.a.10356
R3*** M. Moustafa, C. Simpson, M. Glover, R.A. Dawson, S. Tesfaye,
F.M. Creagh, D. Haddow, R.D. Short, S. Heller and S. MacNeil. A new
autologous keratinocyte dressing treatment for non-healing diabetic
neuropathic foot ulcers. Diabetic Medicine 21(7) (2004)
786-789. doi: 10.1111/j.1464-5491.2004.01166.x
R4 N. Zhu, R.M. Warner, C. Simpson, M. Glover, C.A. Hernon, T.M.
Brotherson, D.R. Ralston, J. Kelly S. Fraser and S. MacNeil. Treatment of
Burns and Chronic Wounds Using a New Cell Transfer Dressing for Delivery
of Autologous Keratinocytes. European Journal of Plastic Surgery 28
(2005) 319 - 330. doi: 10.1007/s00238-005-0777-4
R5 M. Moustafa, A.J. Bullock, F.M. Creagh, S. Heller, W.
Jeffcoate, F. Game, C. Amery, S. Tesfaye, Z. Ince, D.B. Haddow and S.
MacNeil. Randomized, controlled, single-blind study on use of autologous
keratinocytes on a transfer dressing to treat nonhealing diabetic ulcers.
Regenerative Medicine 2(6) (2007) 887-902. doi: 10.2217/174607184.108.40.2067
R6 N.G. Walker, A.R. Mistry, L.E. Smith, P.C. Eves, G. Tsaknakis,
S. Forster, S.M. Watt, S. MacNeil. A Chemically-defined Carrier for the
Delivery of Human Mesenchymal Stem/Stromal Cells to Skin Wounds. Tissue
Engineering Part C: Methods 18(2) (2012) 143-155. doi: 10.1089/ten.tec.2011.0037
Details of the impact
The research led to the development of an evidence-based, commercially
available, cell therapy. This therapy has delivered major healthcare
impact for patients [S1-S4]. The continued commercial availability attests
to the resilience of the product and the economic model developed for its
sustainability. Essentially the product is designed for use only with
`difficult to treat' patients. Fortunately the number of patients with
very severe burns in the UK is low but the impact for these patients is
substantial. Few tissue-engineering companies achieve the translation of
research into effective products. This was achieved by the initial spinout
company, called Celltran Ltd, which ran from 2000 to 2008. Building on the
clinical success of MySkin®, Celltran was acquired by York
Pharma in 2008 and then Ilika in 2009 to further stimulate growth in the
company. The latter company formed a subsidiary Altrika Ltd to focus on
MySkin® and a related product Cryoskin.
Impacts on patients and practitioners:
The commercial availability of MySkin® from 2004 to the
present time has benefited patients, clinicians (burns surgeons,
diabetologists) and dressing nurses using this product to treat patients.
Thanks to Prof MacNeil's proactive approach to disseminating her results
at meetings of burns and wound healing professionals in the UK from 2004
to the present day, the clinical community has been made aware of the
sound evidence base and the potential benefits of the technology, leading
to the gradual adoption of the therapy by practitioners in these areas and
use of the products on patients (MySkin® has been used to treat
over 300 cases since 2008, with each patient requiring up to 50 treatments
by MySkin®). The major health impact of this research has been
the improved outcomes of UK patients with extensive burns — increasing
their chances of survival. The technology has offered burns surgeons in
the UK the potentially life-saving option of a cell expansion and delivery
service for treating those patients who are in extremis and in
danger of death because of the extent of their burns injuries. This is the
only commercial service that burns surgeons can access for
treatment of patients if conventional therapies fail, and (as noted by the
head of the Sheffield Burns Unit, below) patients with major burns
represent a real clinical challenge. For these patients, getting swift
barrier function is essential and difficult. The use of cultured cell
therapy leads to improved health outcomes through greatly reduced risk of
infection and death and shortened stays in hospital [S2]. The Operations
Director of Altrika Ltd says "Use of the cultured cell technology in
burns units has been increasing since 2008 due to the growing evidence
base that early intervention of these therapeutic approaches can be cost
effective, coupled with efficiencies in cost of manufacture that make
the approach more sustainable for a wider patient cohort. Altrika
recently added the burns units in Birmingham and Manchester to its list
of customers, bringing the total number of burns centres in England /
the UK who have used this cell therapy to 11 out of 12, with 6 of these
being regular repeat users" [S1].
The Head of the Burns Unit Sheffield Hospitals says in referring to
MySkin® — "The transition of MySkin® from
research to the clinic, provided through the company CellTran, provided
a commercial service that I or other burns surgeons could access for the
treatment of our patients. At its establishment, it was the first such
commercially available skin service in the UK and to the best of my
knowledge it's still the only commercially available skin cell service.
Thus the company established a valuable clinical resource, which we use
for those extensively burned patients who can't be easily managed with
conventional skin grafting alone. It is only appropriate to use cultured
cell therapy for patients with major burns, these patients represent a
real clinical challenge and it is good to know that in the UK there is a
useful resource based on expanding the patient's cells in the laboratory
which clinicians can access" [S2].
The other health impact has been on patients with chronic non-healing
ulcers, which have failed to heal despite best clinical practice. Patients
with access to cultured cell therapy have benefited from the availability
of the service — cell therapy can stimulate wounds to heal and restore
quality of life. For these patients [S4] MySkin® greatly
improves their quality of life and reduces hospital (or home) treatment
The cell therapy was developed through a University of Sheffield spin-out
company, Celltran Ltd, which was formed in 2000 for the sole purpose of
developing and commercialising the underpinning research, including
providing a strong clinical evidence base for the culture and delivery of
patients' skin cells for clinical benefit. The first product was launched
as MySkin® in 2004. The product is produced in a GMP facility
in Sheffield and has been selling consistently since its launch,
commercialised through a number of different companies:
- Celltran was formed in 2000 and commercialised the technology from
launch in 2004 through to late 2008. The company created 16 jobs and
raised £4 million in investment income from 2004 until 2008. This
supported a team of 16 surface engineers, cell biologists and clinical
staff (burns surgeons, wound care nurses and staff involved in the study
of diabetic ulcers) and staff who set up and ran clean rooms and engaged
in all aspects of the commercialisation of this technology.
- In October 2008 the IP and GMP facility were purchased by York Pharma
for £70k plus royalties for 5 years; the greater of £100k (20k per year)
or 10% of revenues generated.
- In September 2009, Ilika bought the GMP facility, setting up a wholly
owned subsidiary Altrika, solely to commercialise this technology (http://www.ilika.com/history.aspx).
In December 2012, Altrika was bought by Adiposet Ltd, a medical logistics
and service company and continues to commercialise both MySkin®
and CryoSkin. Altrika currently employs 6 people.
Sources to corroborate the impact
S1. Operations Director of the University of Sheffield spin-out
company CellTran Ltd which ran from 2000 to 2009. He then became
Operations Director of the company Altrika Limited who currently produce
MySkin® and a related product (Cryoskin) for the UK market.
MacNeil worked closely with the Operations Director in the development (as
can be seen from our joint publications) and commercialisation of the
product MySkin® while MacNeil was a founder Director of
Celltran until 2007. The Operations Director can confirm the impact of
having a commercially available cell delivery service on the UK clinical
community who purchased this service and on how, having established this
Company, we were able to attract development awards from Research
Organisations (BBSRC and the Wellcome Trust) and Venture Capitalists.
S2. Consultant Burns Surgeon and Head of the Burns Unit Sheffield
Hospitals, who contributed to the initial development and evaluation on
MySkin® in burns patients.
S3. Consultant Burns Surgeon Manchester Children's Hospital who
uses MySkin® for the management of major burns and has been a
regular purchaser of MySkin® for use in major burns for several
S4. NHS Consultant Diabetician, Sheffield Hospitals, who was
involved in the first main clinical evaluation of MySkin® for
diabetic ulcers. (He was involved in the initial clinical evaluation
of MySkin® in the management of patients with
non-healing diabetic ulcers).
(The above clinicians will also be able confirm that this was the
first and only source of cultured skin therapy available to help them
treat patients in the UK. Indeed it remains the only commercially
available service for culture of autologous skin cells for clinical use
in the UK).