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FDA approves clinical trials for pig kidney transplant in humans
The US FDA has approved the first clinical trials for pig kidney transplants in humans. According to the organization, two biotechnology firms – appraidal and egenesis – will test genetically modified pig organs on kidney patients. Experts say the tests are promising but increase safety and moral concerns. Read on to know more.
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According to biotechnology companies, the test is expected to begin by mid -20125
In a major step towards Cross-species transplantationThe US Food and Drug Administration has earlier approved clinical trials for testing pig kidney transplant among those who have kidney failure. Two biotechnology companies – United Theraputics Corporation and Egosis – have been approved to initiate research.
If they are successful, then to address the tests, one can pave the way for new ways to transplant organs in a bid Donor severe kidney shortage“We are entering a transformative era in organ transplantation,” the new York Times Mike Curtis, Chairman and Chief Executive Officer of Engineis.
According to the United Theraputics Corporation, they will start studying with six patients, all of which have been on dialysis for at least six months and have no other serious medical issues. The test will then expand 50 parties, which depend on how initial studies go. Eganesis said they would start with three patients, which would increase the number in later stages.
Many times Said that all patients will be monitored for 24 weeks and will require a lifetime follow -up to track health results and potential risks such as bacteria and viral infections that can easily overcome from pigs to humans.
Pig Kidney is the best solution for human kidney transplant deficiency
According to the data, more than 550,000 Americans have kidney failure, and around 100,000 people are on the transplanting list. Despite this number, less than 25,000 kidney transplants are transplanted every year, and many patients wait for years or die before receiving a donor organs.
Genetically engineer pigs provide a promising solution because their organs are similar in human kidney size and function. Both companies have revised pig genes to reduce the risk of rejection of the organ and improve compatibility with the human body.
United theraputics pigs have edited 10 genes, which add six human genes and remove four Porsin genes associated with rejectionSimilarly, egenesis pigs have been edited 69 genes, to neutralize most viruses that can pose risk for humans.
Concerns of safety and morality there are
While cross-species transplantation has many possible benefits, experts are also concerned about safety and morality. Scientists say that infection can be transported from pigs to humans-many of them are threatened to life.
In addition, many people are worried that those who are in the waiting list for patient organ transplantation may not actually be in a position to agree, given how difficult it is to deny a possible life-saving solution on dialysis. And so, it can be difficult to fully understand the lifelong implications of the decision.
Tests to start by mid -20125
According to the two companies, test implants are expected to begin by mid -2012, with a few months between procedures to assess each result before proceeding. Egenesis is planning to wait six months between her first two patients, then three months before transplanting the third.
Many times Even if the tests are positive and successful, it is not known what will be the cost of pig organ transplant and what insurance will cover them.
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United Therapeutics Corporation and EngiesDonor severe kidney shortagePorsin genes associated with rejectionConcerns of safety and morality