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York,
21
October
2013

Tissue Regenix announces publication of results of DermaPure (human decellularised dermis) UK trial in leading wound care journal

Paper shows 60% of patients with chronic wounds were completely healed and patients treated saw an average 87% reduction in the size of their wounds

DermaPure™ can be easily applied in hospital or community settings  

 

Tissue Regenix Group plc (AIM:TRX) (“Tissue Regenix” or “the Group”), the regenerative medical devices company, has today announced that the full trial results into the effectiveness of DermaPure™ in healing treatment resistant chronic wounds, previously referred to in an announcement on 2nd May 2013, have now been published in the peer reviewed journal - Wound Repair and Regeneration.

The clinical trial into the effectiveness of DermaPure™ in Wound Repair and Regeneration, was undertaken by the University Hospital of South Manchester with NHS Blood and Transplant (‘NHSBT’) on patients with chronic wounds, with 70% of the test group suffering from venous leg ulcers.

The other key highlights of the paper were:

Potential community-based treatment

The paper states that with an aging population, and increasing prevalence of diabetes and obesity, current strategies such as compression bandaging, are expensive, labour-intensive, and slow to show results. With no requirement for hospital admission or anesthetic, DermaPure™ (dCELL® Dermis) could be administered in hospital and community settings, such GP clinics and can be stored at room temperature, meaning expensive refrigeration equipment is not needed.

Virtually no recurrence of wounds at 6 months

The results show that patients who had chronic wounds[1] for an average of 4½ years and who were treated with a single application of Tissue Regenix’s dCELL® Dermis, saw an average 87% reduction in the size of all wounds, while 60% of patients were completely healed, with virtually no recurrences.

DermaPure™ uses the dCELL® patented process which removes cells and other components from donor human dermis tissue, allowing it to be used as a patch to place over open wounds, in a single application. The treatment maintains the essential structure of normal skin and serves as an ideal scaffold to kick start the healing process and regenerate living, functional skin tissue.

The clinical trial report states that the product: “Has comparable biomechanical properties to the injured tissue. This is crucial as scaffold characteristics including elasticity, porosity and bio-compatibility have been shown to mediate beneficial cellular activity during healing.”

DermaPure™ is planned for launch in the US during the first half of 2014 and Tissue Regenix is well advanced in its plans to appoint distributors and the US clinical trial using DermaPure™ to treat diabetic foot ulcers. Tissue Regenix’s UK partners NHSBT (NHS Blood & Transplant) are working towards launching the product in the UK.

Background to the Study

The twenty patients involved in the trial underwent hydrosurgical debridement, after which the dCELL® Dermis was applied and covered with negative pressure dressings for one week. Participants were reviewed using technology such as 3D photography, on seven occasions over a period of six months.  Complete healing was accomplished in 12 out of the 20 patients treated.

The clinical paper states that 1-in-100 people in the UK will suffer from a leg ulcer during their lifetime, with treatment of these chronic wounds taking 1% of the country’s annual healthcare budget.

The clinical trial report concludes that: “we have demonstrated that DCD (decellularised Dermis) and its application process safely promoted wound healing in treatment-resistant chronic lower limb ulceration. The procedure is well tolerated, and patients commonly reported that ulcer-associated symptoms including pain, discharge, and malodour rapidly reduced or resolved after treatment. It can be performed on an outpatient basis in a treatment room with no requirement for theatres, general anaesthetic, or formal admission to hospital. Consequently, the technique could be applied in community and hospital settings.”

The full trial results are available at:

 http://onlinelibrary.wiley.com/doi/10.1111/wrr.12113/abstract;jsessionid=82733BBFD345FBB8F94D73E8A879E0CB.f01t04

 


[1] Chronic wounds defined as a break in skin epithelial continuity persisting for longer than 42 days or of frequent recurrence-

Fonder MA, Lazarus GS, Cowan DA, Aronson-Cook B, Kohli AR, Mamelak AJ. Treating the chronic wound: a practical approach to the care of nonhealing wounds and wound care dressings. J Am Acad Dermatol 2008; 58: 185–206.

Boilerplate

About Tissue Regenix

Tissue Regenix is a leading medical devices company in the field of regenerative medicine. The company’s patented decellularisation (‘dCELL®) technology removes DNA and other cellular material from animal and human tissue leaving an acellular tissue scaffold which is not rejected by the patient’s body which can then be used to repair diseased or worn out body parts. The potential applications of this process are diverse and address many critical clinical needs such as vascular disease, heart valve replacement and knee repair.

Tissue Regenix was formed in 2006 when it was spun-out from the University of Leeds. The company commercialises academic research conducted by our partners around the World.

In November 2012 Tissue Regenix Group plc set up a subsidiary company in the United States- ‘Tissue Regenix Wound Care Inc.’, as part of its commercialisation strategy for its dCELL® technology platform.