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Surgeons in Sweden have carried out the world's first synthetic organ transplant. Scientists in London created an artificial windpipe which was then coated in stem cells from the patient. Crucially, the technique does not need a donor, and there is no risk of the organ being rejected. The surgeons stress a windpipe can also be made within days.
The 36-year-old cancer patient is doing well a month after the operation. Professor Paolo Macchiarini from Italy led the pioneering surgery, which took place at the Karolinska University Hospital. In an interview with the BBC, he said he now hopes to use the technique to treat a nine-month-old child in Korea who was born with a malformed windpipe or trachea.
Professor Macchiarini already has 10 other windpipe transplants under his belt - most notably the world's first tissue-engineered tracheal transplant in 2008 on 30-year-old Spanish woman Claudia Costillo - but all required a donor.
Indistinguishable
Doctors in Sweden announced last week they had transplanted a laboratory-made windpipe into Andemariam Teklesenbet Beyene, a 36-year-old Eritrean. While studying at a university in Iceland, he was diagnosed with advanced cancer and had a large tumor almost completely blocking his windpipe. His Icelandic doctor referred Beyene to Dr. Paolo Macchiarini, a surgeon at Stockholm's Karolinska Institute who has done windpipe transplants in the past. Macchiarini suggested replacing Beyene's damaged windpipe with one made in a laboratory. "He explained that this has never been done to human beings," Beyene told the Associated Press Thursday. "I said, 'Oh my God.' If this has not been done, how can I agree to this?"
But after talking to his Icelandic doctor and to his family, including his wife and two children in Eritrea, Beyene agreed to the revolutionary transplant. "Then I just prayed and accepted it," he said. "I was happy with the operation." Beyene's new windpipe was made using a spongy, plastic polymer to speed cell growth. The device has previously been used in tear ducts and blood vessels. Once the windpipe was constructed in the laboratory, Beyene's own stem cells were used to create millions of other cells to line and coat the windpipe. That meant Beyene's body wouldn't reject the new organ and that he doesn't need to take anti-rejection medicines.
Other windpipe transplants have been performed using donor windpipes and the patient's own stem cells to cover the new trachea, but Beyene's case is the first to use a man-made organ. Beyene recently arrived back in Reykjavik and is now recovering at the national hospital. His doctors will run scans on his new windpipe every six months for at least the next five years. They will be monitoring Beyene for any possible complications, including possible infections. Beyene isn't sure when he will be released from the hospital but hopes to return to Eritrea to see his family soon. "I am very eager to see them and they are very eager to see me," he said. "But it depends on the health situation."
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Surgeons retrieving organs for transplant just after a donors heart stops beating would no longer have to wait at least two minutes to be sure the heart doesnt spontaneously start beating again under new rules being considered by the group that coordinates organ allocation in the United States. The organization is also poised to eliminate what many consider a central bulwark protecting patients in such already controversial cases: an explicit ban on even considering anyone for those donations before doctors and family members have independently decided to stop trying to save them.
The proposed changes by the United Network for Organ Sharing, the Richmond nonprofit organization that coordinates organ donation under a contract with the federal government, are part of the first major overhaul of the 2007 guidelines governing donation after cardiac death, or DCD, which accounts for a small but growing percentage of donations each year. Proponents say the changes strengthen the transplant system by aligning the rules with other regulatory bodies and better ensure that the wishes of donors and their loved ones are honored without sacrificing necessary protections. The ultimate goal is to facilitate the dying wishes of patients who wish to be donors and save the lives of the 112,000-plus patients who are in need, said Charles Alexander, the immediate past president of UNOS. We are always very aware of our public trust.
Critics, however, say the move heightens the risk that potential donors will be treated more like tissue banks than like sick people deserving every chance to live, or to die peacefully. This is another step towards this idea of hovering, hovering, hovering to get more organs, said Michael A. Grodin, a professor of health law, bioethics and human rights at Boston University. The bottom line is that they want to do everything they can to increase organ donation. The 16-page proposal, which has resurrected the knotty debate over what it means to be dead, was drafted over a year by the 22-member UNOS organ procurement organization committee. It was posted for public comment for about three months, a period that ended June 10. The UNOS board will convene Nov. 14 and 15 in Atlanta to finalize the revisions, which include officially shifting the guidelines from model elements to requirements.
We want the process to happen the way its supposed to happen to avoid any questions or problems, Alexander said. DCD involves surgeons taking organs within minutes of respirators and other forms of life support have being cut off from hospitalized patients who still have at least some brain activity. DCD had been the norm for organ donors before neurological criteria brain death became the standard in the early 1970s. Since then, most donors have been brain-dead.
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Organ transplant recipients have a much greater risk of cancer than the general population, according to a new study, but the reason is not entirely clear. Cancer growth is often triggered by viruses, and the bodys immune system helps keep those viruses in check. But transplant recipients get powerful drugs to suppress their immune system, so that they don't reject the transplanted organ. Researchers have known that transplant recipients are more likely to get cancer, but this new study, published in JAMA, shows how much more likely.
Lead author Eric Engles, of the U.S. National Cancer Institute, says getting an organ transplant can double your risk of cancer during the year after transplant. So, if a population like ours would be expected to develop about seven cancers in 1,000 people, we observed about twice that - about 13 or 14 cancers among 1,000 people [who got transplants] followed for one year. Engles and his colleagues used records of 175,000 U.S. transplant patients. Kidney transplants were the most common, followed by liver, heart and lung. The cancers sometimes showed up in the transplanted organ. Kidney cancer was most common in kidney recipients. Likewise, lung cancer among lung recipients.
But other cancers didn't have a direct link with the organ that was transplanted. For example, the most common cancer among transplant recipients is non-Hodgkin lymphoma, which affects the immune system. And this is seen in immuno-compromised people, and it's due to a virus, Epstein-Barr virus," Engles says. "And we saw a very elevated risk for this cancer, particularly among lung recipients, and we think that that high risk might relate in part to the fact that those people receive especially intense immune suppression.
Even though transplant patients may face a doubled risk of cancer, Engles says it must be put into the context of other transplant risks - including organ rejection and infection - and the procedures benefits. Transplantation is a life-saving therapy and is one of the miracles of modern medicine. Cancer is one of the important complications of transplantation, but it's not the only one.
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The message for women considering hip replacement surgery remains unclear. It's not known which models of hip implants perform best in women, even though women make up the majority of the more than 400,000 Americans who have full or partial hip replacements each year to ease the pain and loss of mobility caused by arthritis or injuries. "This is the first step in what has to be a much longer-term research strategy to figure out why women have worse experiences," said Diana Zuckerman, president of the nonprofit National Research Center for Women & Families. "Research in this area could save billions of dollars" and prevent patients from experiencing the pain and inconvenience of surgeries to fix hip implants that go wrong.
Researchers looked at more than 35,000 surgeries at 46 hospitals in the Kaiser Permanente health system. The research, published Monday in JAMA Internal Medicine, was funded by the U.S. Food and Drug Administration. After an average of three years, 2.3 percent of the women and 1.9 percent of the men had undergone revision surgery to fix a problem with the original hip replacement. Problems included instability, infection, broken bones and loosening. "There is an increased risk of failure in women compared to men," said lead author Maria Inacio, an epidemiologist at Southern California Permanente Medical Group in San Diego. "This is still a very small number of failures."
Women tend to have smaller joints and bones than men, and so they tend to need smaller artificial hips. Devices with smaller femoral heads - the ball-shaped part of the ball-and-socket joint in an artificial hip - are more likely to dislocate and require a surgical repair. That explained some, but not all, of the difference between women and men in the study. It's not clear what else may have contributed to the gap. Co-author Dr. Monti Khatod, an orthopedic surgeon in Los Angeles, speculated that one factor may be a greater loss of bone density in women.
The failure of metal-on-metal hips was almost twice as high for women than in men. The once-popular models were promoted by manufacturers as being more durable than standard plastic or ceramic joints, but several high-profile recalls have led to a decrease in their use in recent years. "Don't be fooled by hype about a new hip product," said Zuckerman, who wrote an accompanying commentary in the medical journal. "I would not choose the latest, greatest hip implant if I were a woman patient. ... At least if it's been for sale for a few years, there's more evidence for how well it's working."
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In the United States alone, an estimated 17,000 people a year with end-stage kidney disease are able to receive a life-saving donor organ. But thats only a fraction of the patients on waiting lists for transplantable kidneys. About 90 percent of them are on dialysis; many die waiting. That makes the achievement by researcher Harald Ott and colleagues at Boston's Massachusetts General Hospital especially exciting, says Stephen Badylak, a pioneer in the field of organ regeneration at the University of Pittsburgh in Pennsylvania. So, this has the potential to take care of that [donor shortage] problem and, even better, if it works, the patients who receive these types of engineered organs wont have to receive an immunosuppressant," said Badylak. "I think everyone on renal dialysis now would applaud this work. Dr. Badylak's own work in regenerative medicine involves developing livers for transplant. Dr. Otts team used a detergent to completely cleanse the rat kidney of living tissue, leaving a protein framework that retains the structure of the blood vessels and other parts of the organ.
The scientists then repopulated that framework with human cells for the blood vessel linings, and kidney cells from newborn rats. The reassembled organ was then put in an incubating chamber for five days to let the tissues grow. The result was a functioning rat kidney. Although the regenerated rat kidney in Ott's study produced urine, it did not function as well as a natural organ. Its possible, says Stephen Badylak, that patients needing transplants could have their own dysfunctional organs regenerated in the same way. Badylak says they would not have to take immunosuppressant drugs, with all their unpleasant side effects, to keep their bodies from rejecting a donor organ. At the rate the field is progressing, Badylak predicts organ regeneration could become a real option for human transplant patients in five to seven years. But he's concerned about major regulatory hurdles. We are going to be ready to help people with this before we are going to have regulatory agencies telling us 'wait until we figure out how to handle it.' This should be a wake up call for them to say, This is coming," he said. "How are we going to take care of this?'
Curt Civin leads the Stem Cell Biology and Regenerative Medicine Center at the University of Maryland School of Medicine in Baltimore. He says hematopoietic stem cells, or master cells from bone marrow, have been studied longer than any other tissue. Civin says the blood stem cells from marrow are at the heart of regenerative medicine because they animate the organ scaffold, making it function. But Civin believes the complexity of the field means it will be a while before entire customized organs, such as kidneys, are available for human transplant. So I think this problem will yield - in perhaps one decade, perhaps two decades - to where we have lots of rats and mice and other animals with transplanted kidneys made from stem cells, maybe by techniques very much like this, and then were at the setting to study in the [human] patients," said Civin.
The U.S. Food and Drug Administration, which has regulatory authority over any new drugs, medical devices and procedures, did not offer a comment. The agency has strict guidelines requiring data from clinical trials before deciding whether to approve a procedure - a process that can take years. But the FDA also has a fast-track approval process to expedite the review of drugs or in this case, the regeneration of organs for transplantation, when there is a serious, unmet medical need. An article on the creation of a functioning rat kidney by Harald Ott and colleagues is published in the journal Nature Medicine.
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