An end to ulcers?

By Kate Horowitz

A new Australian wound-healing invention has shown very promising results in an international human trial.

Clinical trials of a product called VitroGro, developed at the Queensland University of Technology (QUT), found 92 per cent of the patients taking part in the trial were partially or completely healed in 12 weeks.

The clinical trial – led by the Cardiff University Wound Healing Clinic in conjunction with QUT’s Wound Clinic in Brisbane – evaluated VitroGro in the treatment of venous leg ulcer patients who had not responded to compression therapy, which is the current standard of care.

Out of a total of 53 patients recruited for the study, 24 patients have been evaluated so far. Eight patients’ ulcers have completely healed and two have achieved more than 98 per cent healing.

The average reduction in wound size was 65 per cent, with no reported adverse events related to the product.

VitroGro is a liquid that is applied using a needle-less syringe and is dribbled over the wound. The protein in the liquid is extremely sticky and so very quickly adheres to the wound bed, offering a revolutionary new treatment.

Above: Professor Zee Upton from QUT’s Institute of Health and Biomedical Innovation

Professor Zee Upton, from QUT’s Institute of Health and Biomedical Innovation, is also the technical founder and consulting Chief Scientific Officer for Tissue Therapies Limited – a biotechnology company developing VitroGro.

She says the product was biologically inspired and developed to emulate the way nature repaired wounds.

“For conditions like venous ulcers where the biology of healing is aberrant, VitroGro provides critical adhesion for cells by forming a scaffold they can attach to and migrate upon. It creates a favourable environment for healing and this is something that has been missing from conventional wound care.”

Professor Upton said they were very excited by the trial results because it was a new formulation which they expect will be very cost effective to consumers.

“There’s nothing else like it in the market in terms of approach, outcome or cost effectiveness,” she said.

The preliminary data confirms the results of earlier Australian and Canadian human trials by showing that VitroGro restarts or accelerates healing of chronic venous ulcers that don’t respond to expert care, reducing the ulcer size as well as improving wound characteristics and reducing pain.

“Patients have also reported that their pain has improved, which is important as these wounds are often quite painful and people in the trials have been living with them for years – in one case, 30 years,” Professor Upton said.

‘Amazed’ by results

CEO of Tissue Therapies, Dr Steven Mercer, says he was amazed by the trial results.  “It was remarkable one patient had 7 years of expert treatment on her ulcer. In addition to her regular treatment, VitroGro healed her wounds completely in 12 weeks.”

The average treatment time that patients’ venous ulcers had not responded to expert care before VitroGro treatment was 37 months.

“The packaging is such that it is easy to use by patients themselves. It is also compatible with most dressings and can be used alongside other treatments.” Dr Mercer said.

According to Dr Mercer, the product will match the current price of wound care products on the market and due to the enhanced efficiency of VitroGro, the product will be used by the patient for a shorter duration.

“We estimate it will cost $100 a week; this is approximately what wound care is costing patients at the moment. The product causes acceleration of cell growth so VitoGro will not be needed to be used as long as standard treatments.”

Chronic wounds affect hundreds of thousands of Australians, particularly older Australians and people in Indigenous communities.

According to Professor Upton, these wounds are “painful and debilitating, resulting in extreme reductions in the quality-of-life of sufferers across months, years and potentially decades.” 

“For many patients living with chronic non-healing wounds, amputation of an affected limb is the only option,” she said.

Tissue Therapies is currently in final negotiations with commercial partners.  They believe the results position VitroGro well for approval by the Therapeutic Goods Administration in Australia and planned first sales in Australia and Europe in the second quarter of 2012.  Trials are also expected to commence in the United States early next year.