Dal – Engineering A Natural Solution For Chronic Diabetic Wounds

Introduction: Alarming Statistics Someone in the world is losing a limb to diabetes every 20 seconds. An estimated 366 million people worldwide are affected by diabetes. Of those, 15–20% experience non–healing (chronic) foot ulcers and of those, 85% will ultimately require amputation. In starker terms, someone in the world is losing a limb to diabetes every 20 seconds. As the number of people afflicted by diabetes is increasing significantly every year, expected to reach 439 million by 2030, equivalent to 7.8% of the world adult population, this problem can only be expected to grow. In Canada, nine million people are affected with diabetes today; by 2020, $16.9 billion dollars will be spent directly on diabetes. Our lab has developed a new way to heal diabetic foot wounds that could potentially eliminate the need for amputation; we are working to make it available to patients. An Unmet Need The options for treating foot ulcers in people with diabetes are often insufficient. Currently in Canada, the standard of care involves removing dead or infected tissue within the wound site, wrapping the wound with saline–soaked sterile gauze and providing a method to keep the patient from walking on the affected area during healing. The patient will be seen weekly and the standard of care treatment will be repeated until healing is successful, a process that can take up to six months. Often, however, healing does not occur. The risk of the patient experiencing an infection increases dramatically if significant healing (>50%) does not occur within four weeks. Infected wounds can receive another level of treatment involving the application of anti–microbial dressings and topical anti–septic agents. If these measures fail, the infection will persist and spread, until surgical removal of the affected portions of the foot is the only option. There is a third line of treatment prior to amputation, which involves the use of biologic agents or engineered tissues. This is used in the United States but, due to the very high cost of these treatments, it is used very infrequently and usually as a last–ditch effort to save the affected limb from surgical amputation. Currently, these types of products are not available in Canada for the treatment of diabetic chronic wounds. Patient, Heal Thyself Our Matrix Engineering Lab at Dalhousie University is using a technology known as “decellularization”. In a process somewhat analogous to removing the yolk and the white from an egg without damaging the shell, we extract immune–reaction inducing cellular materials from animal or human tissues. This leaves behind an intact, native, non–living protein matrix scaffold that acts as a foundation for the repair and regeneration of tissues. The scaffold is both safe and sterile, because decellularization has removed any bacteria or viruses from tissues. Our research has shown that, after decellularization and with the processing methods we have developed, the remaining scaffolds retain the essential properties of their tissue of origin. Further, these scaffolds encourage cells to migrate back into them and begin forming new living tissue. This has been shown for a variety of tissues obtained from animals and, most recently, humans. These results indicate that once the decellularized scaffolds are implanted into a patient’s body, they can combine with the patient’s own cells to repair and ultimately regenerate new living tissue. Translating This New Treatment to the Patient There are a number of areas where decellularization of human tissues would have a great impact on patient treatment and outcomes. One growing and unmet need identified early on was the treatment of chronic diabetic wounds. The use of decellularization technology could potentially eliminate the need for amputation. To be successful, however, the decellularization technology would not only have to be effective at healing the wounds, but also easy to use and cost effective. With commercial development funding from CIHR and Nova Scotia funding agencies (Springboard Atlantic, InNOVAcorp, ACOA) and support provided by the Capital District Health Authority (CDHA) in Halifax, we have developed a sterile decellularized human skin–derived scaffold capable of facilitating healing in chronic diabetic wounds. In addition, to ensure that this new treatment would be affordable and, therefore, available, we developed in parallel an innovative automated manufacturing system to provide large numbers of these scaffolds at a very low cost. As a result, the new technology can be used as a front–line treatment and create a new standard of care for treating chronic diabetic wounds. We have secured patent protection for our discoveries and we have established a company, DeCell Technologies Inc., which will be bringing decellularized tissue–based products to the Canadian market and, in turn, to Canadian patients. Currently, DeCell Technologies Inc., is completing pre–clinical studies on its first decellularized human tissue derived product, called DermGEN. This product is specifically targeted at treating chronic diabetic foot ulcers and will be undergoing clinical testing with diabetic patients in the fall of 2013. We anticipate that our product can potentially eliminate amputation as a necessary option in the treatment of chronic wounds in diabetic patients within two–to–three years. Acknowledgments Collaborators: Sean Margueratt, DeCell Technologies Inc.; Karl Conlan, DeCell Technologies Inc.; Jason Williams MD, QEII Health Sciences Centre; Martin LeBlanc MD, QEII Health Sciences Centre; Amanda Murphy MD, QEII Health Sciences Centre; Paul Hong MD, IWK Hospital; Michael Bezuhly MD, IWK Hospital; Barbara Campbell,Hammock Facilitation Inc.; Diana Pliura PhD, CEO, Albry Inc.; Halifax Regional Tissue Bank (HRTB); Sean Moulton (HRTB) Funding: Canadian Institutes of Health research (CIHR), InNOVAcorp, Springboard Atlantic, Halifax Capital District Health Authority (CDHA), Atlantic Canada Opportunities Agency (ACOA)