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During the trials, two volunteers suffering from type 1 diabetes were given preliminary tests. Type 1 diabetes is an auto-immune disease which damages the insulin-producing islet cells of the pancreas. Insulin is very essential to control blood sugar level of a person and the patients who suffer from this disease have to face insulin injections for their entire lifetime. This prevents them from surges of glucose levels in the blood which can sometimes be fatal for the human beings. Robert Elliott, the project leader and co-founder of the Living Cell Technologies said that after using the technique, the volunteers who were used in the study became independent of insulin injections for a number of months. Preliminary tests have also been conducted on the primates which showed no side-effects after the treatment. Elliot said that after the preliminary tests, only clear benefits were shown, in addition to very minor risks involved. Therefore, it has been decided that they should go ahead with the clinical trial. The results of the preliminary tests were presented in the annual meeting of International Society for Cell Therapy during May 2009. A larger clinical study will be conducted in which 18 volunteers will be tested with the radical technique. Because the suspension on xenotransplantation exists in Australia, the study will be held in New Zealand and Russia. However, nothing is decided yet and the place will be announced later in 2009. Recently, volunteers in the New Zealand started received porcine cells capsules in their abdomens under a local anesthesia. All the volunteers are suffering from type 1 diabetes. The researchers intentionally include some patients with unstable diabetes condition in the trial. The condition of these patients is controlled poorly by the insulin treatment. After an evaluation period of 2 months, the volunteers will be monitored for several months or years and if the transplants are found to be successful, the patients will no longer require to be treated with insulin injections. Because there are far less human donors to cater for transplant demands, the need for the animal pancreatic tissues was realized. But earlier studies that used xenotransplants are not successful at showing good results for treating diabetes. And none of them have ever used encapsulation technique in which transplanted pig cell clusters are spared from ravages of host immune system. Elliot said that the transplanted cells need to be protected from two things, one is from the rejection of the foreign tissues and the second thing is the diabetes itself, the condition in which the human body immune system attacks the pancreatic tissues. According to Elliot, the pigs that were used in these transplantations were bred and were kept in exceptionally sterile environments, which kept them free from viruses, parasites and bacteria. Apart from that, tests have depicted that retro-viruses that are present in the genes of the pigs in a hidden manner are not able to produce viable particles of viral. Such viruses were discovered in pigs in the 1990s and since then, xenotransplantation has been held back. Anthony d’Apice, the director of Immunology Research Center of the St. Vincent’s Hospital in Melbourne, says that first the risk and benefit ratio will be demonstrated and then only it will be decided whether the procedure is successful or not. The trial aims at minimizing the risks of failure and also the risks of infection which is harmful not only for the patients but also for their community and people around. This condition can be the result of any known or unknown organism including porcine endogenous retro-viruses. Jonathan Stoye, virologist at the National Institute of Medical Research in UK and advisor on xenotransplant safety to British Government, supports the study. Stoye says that although the porcine viruses related risks are much lower than anticipated, the condition can never be completely discounted. Clinical data will be analyzed before reaching any conclusions but the trial seems to be very successful. |
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