Innovative Regenerative Approach to Healing Diabetic Foot
Ulcers Now Being Trialed at Two Additional UK sites
• Two London hospitals join the study to evaluate safety and effectiveness of new approach using
ReGenerCell™
• Innovative regenerative technology uses patients’ own skin cells to close wounds caused by
chronic Diabetic Foot Ulcers (DFUs)
• Diabetes costs the NHS £8.8bn pa (almost 10% of the NHS budget) with 140 diabetic patients a
week having an amputation
London, United Kingdom, Perth, Australia and Northridge, CA – 9 November 2016 – Treatment is now
underway at three UK hospitals to trial an innovative approach of using a patient’s own cells to close
foot ulcers amongst diabetics, an affliction that leads to some 140 amputations per week across Britain.
Avita Medical (ASX: AVH), (OTCQX: AVMXY), a regenerative medicine company specialized in wound
treatment, said two new sites have been added to the study on the safety and effectiveness of its
treatment of Diabetic Foot Ulcers (DFUs), and that ReGenerCell™ device is now deployed at London’s
King’s College and Northwick Park Hospitals. The DFU clinical trial began earlier in 2016 at the
Manchester Royal Infirmary, with seven patients already enrolled and being treated at that site.
Avita said that with three sites now enlisted, enrollment can proceed apace to recruit up to 24 patients
with DFUs, who will be followed over a 26-week evaluation period. Full enrollment of the trial is
anticipated to be completed by early 2017. The treatment will be assessed as an adjunct to standard of
care treatments, such as debridement, cleansing, dressings, and offloading. As well as the key outcome
measures of incidence of healing and rate of wound closure, the study will also explore patient and
physician satisfaction. ReGenerCell™, which is CE-marked and approved for sale in the UK, enables
medical professionals to create an autologous suspension of the patient’s own skin cells, which is then
applied to the wound to trigger healing.
ReGenerCell™ has already delivered positive outcomes in a Venous Leg Ulcer (VLU) trial, which showed
statistically significant wound closure amongst the 52 patients participating. The device has also been
deployed to treat pre-tibial lacerations, another category of long-term wounds that can defy treatment
amongst typically elderly patients. Avita now hopes to show effectiveness amongst the massive diabetic
patient group.
According to recent Public Health England data, diabetes now affects 3.8 million adults in the UK and
costs the NHS around £8.8 billion a year to treat. Approximately 100,000 diabetics in the UK suffer from
a DFU, a widespread complication of poorly controlled diabetes. DFUs can remain as open wounds for
years, limiting patients’ mobility and lifestyle, and risking infection, often leading to amputation if not
treated effectively.
“There is a real need to find a new way of treating DFUs, especially when various other approaches have
failed to close the wound,” said Mr Naveen Cavale, Consultant Plastic, Reconstructive & Cosmetic
Surgeon at King’s College Hospital.
The sentiment was shared by Ms Sophie Renton, Consultant Vascular Surgeon at Northwick Park
Hospital, who added: “It is projected that more than five million Britons will be diabetics by 2025, so
there is real urgency that we explore different approaches, such as ReGenerCell™.”
Avita CEO Adam Kelliher welcomed the addition of the two London hospitals to the trial, and said that
the Company would also be gathering health economics data on the approach.
“Everything about DFU treatment is expensive: the daily dressing changes, the continuous attention
needed throughout the public health system, and sadly, the significant surgery of amputation,” Kelliher
said. “If we can break this cycle by closing the foot ulcers, we can improve the lives of many people, and
save a lot money.”
This study builds on successful studies in Italy, of DeAngeles et al (2013)1 and, in China, of Hu et al
(2015)2 who have shown positive clinical outcomes with the use of Avita’s Regenerative Epithelial
Suspension™ technology in the treatment of diabetic foot ulcers.
