***PKTX..***Shapiro has filed a patent for the new transplant technique and hopes to soon begin human trials.
...Over the last 32 months Dr. Shapiro and his team have been extensively testing the AAGP™ molecule in allogeneic transplants using human islet cells as the model. As regenerative medicine is rapidly becoming adopted in the treatment of degenerative diseases, the protection of the transplanted cells, tissues, and organs is of paramount importance. Transplanted cells and tissues are subjected to extreme stress factors that, unless protected, could cause failure to graft or premature death. The success of the tests conducted in Edmonton have demonstrated that AAGP™ has the potential to be widely adopted in many areas of regenerative medicine.
.."I'm very excited about our ongoing collaborations with PKTX and by the remarkable potency of AAGP. This molecule has great potential, and we are just beginning to scratch beneath the surface," said Dr. James Shapiro.
...As a result of the tests, Dr. Shapiro and his team are developing further testing based on three primary activities:
..1. The ongoing testing and refinement of cellular transplantation using human islet cells as the demonstrated model. In particular, AAGP™ may provide powerful protection against hostile agents that severely inhibit engraftment success. Cell therapies are currently being developed around the world for the treatment of spinal cord injury, damaged heart tissue, stroke, diabetes as well as many other conditions.
..2. Human organ preservation. The program will assess the effect of AAGP™ in extending the transplant viability of donor organs. The Canadian National Transplant Research Program is a major national initiative involving the Federal institutes of health, all Provinces and the private sector. http://www.cntrp.ca/. The first testing will be conducted on livers to determine whether AAGP™ can extend the ex-vivo functionality of the organ.
..3. Auto immune disease. This class of diseases occur where the body's immune system starts to attack healthy cells. Diseases in this category include, rheumatoid arthritis, multiple sclerosis and Type 1 diabetes. Using the NOD (Non Obese Diabetic) mice as a model the Edmonton team will be specifically assessing the potentially protective effect of AAGP™ against the antibody attack conducted against the islet cells in the pancreas.
...“This impressive team of transplant surgeons and scientists have made clear to us the dramatic scope of applications that our family of molecules possesses,” said Clarence Smith, President, CEO and Chairman of the Board of ProtoKinetix.
.....Edmonton's James Shapiro, a world-leading expert in emerging treatments of diabetes, says his latest research could soon mark a new standard for treatment and it lies right beneath the skin.
..Shapiro, a Canada Research Chair in Transplantation Surgery and Regenerative Medicine in the University of Alberta's Faculty of Medicine & Dentistry, along with Andrew Pepper, a post-doctoral student, are the lead authors in an April 20 study published the journal Nature Biotechnology.
..In the study, the authors describe developing a new site for islet transplantation under the skin, which they believe will offer less risk and far greater health benefits for patients.
..Islet transplantation is a procedure that temporarily allows severe diabetics to stop taking insulin.
.."Until now it has been nearly impossible for transplanted cells to function reliably when placed beneath the skin," says Shapiro.
.."In these studies, we have harnessed the body's natural ability to respond to a foreign body by growing new enriching blood vessels. By controlling this reaction, we have successfully and reliably reversed diabetes in our preclinical models. This approach is new and especially exciting as it opens up a world of opportunities, not only in diabetes, but also across the board in regenerative medicine."
..The new technique, tested in pre-clinical models, is an evolution of the Edmonton Protocol, which Shapiro developed in the late 1990s to treat Type 1 diabetes.
..In the Edmonton Protocol, islet cells are transplanted into the liver, granting patients insulin independence for a varying amount of time. While hailed as a revolutionary treatment, Shapiro quickly realized the liver wasn't the ideal site for transplantation as most of the islets were destroyed in a matter of minutes to hours. As he considered the future possibility of transplanting human stem cells in place of islets, he realized a better, safer site to implant experimental cells was needed.
..So Shapiro's team began testing an alternative site underneath the skin, but at first it proved inhospitable for the cells due to a lack of blood vessels needed for the islets to grow and reproduce. As part of their research though, they found that by inserting a temporary catheter tube under the skin, new blood vessels could be induced to grow, making an ideal home for islet transplantation.
..Shapiro adds that the "exciting new approach doesn't have to be limited to diabetes."
.."For any area of regenerative medicine that requires replacing old cells with new -- and there's lots of different disease states where there's just one gene defect that could be corrected by a cell transplant -- this opens up an incredible future possibility for successful engraftment beneath the skin."
..Shapiro has filed a patent for the new transplant technique and hopes to soon begin human trials..