PIG CELL TRANSPLANT BACK FOR REVIEW IN NEW ZEALAND

DATE: May 06, 2005

In 1997, a controversial trial in which six diabetics received insulin-producing pig cells was canned, amid fears the treatment could unleash a pig virus in humans. Eight years later, one of the trial volunteers can't wait to do it again, according to a study issued last month by the trial's medical director, Professor Bob Elliott, now medical director of Living Cell Technologies of New Zealand. A 40-year-old New Zealand man suffered no ill effects from the treatment, which was stopped on the orders of Health Ministry officials. His daily insulin dosage dropped in the first year but returned to pre-transplant levels within two years. The man insists xenotransplantation helped him control his diabetes over the next seven years, Professor Elliott says. <>Under existing law, xenotransplantation trials are allowed only with ministerial permission. New Zealand's Bioethics Council is due to make recommendations to Environment Minister Marian Hobbs in August after listening to what New Zealanders think about the controversial treatment. A council working party has just completed its first round of "dialogue" meetings focusing on cultural, spiritual and ethical issues. Their brief does not extend to safety or effectiveness.

Some people find it repugnant, others worry about the risk of animal illnesses crossing to humans, says Professor Elliott, who was at the Auckland meeting. "There are animal rights people who feel that the use of animals is just not on and certain other individuals who have various ethnic or cultural beliefs. "My own view is that this would not be offered to the general public. This would be strictly controlled. If we do trials in New Zealand, it would be on a small number of people and we would review the results before going any further. We would follow American Food and Drug Administration guidelines, which are the best worked-out in the world, to the letter." <>Canada and Australia have adopted moratoriums. Sweden, Switzerland, Spain, the United Kingdom and United States allow some xenotransplantation under strict guidelines. China and Mexico, where pig cell transplants are available for $30,000, are less regulated. Chinese authorities have approved a trial where adrenal cells, taken from slaughterhouse cattle, are injected into cancer patients for pain relief. "They plan to do 2000 patients a day," Professor Elliott says.

Martin Wilkinson, who heads the Bioethics Council xenotransplantation working group, says it is unknown how many New Zealanders have had such transplants overseas and what, if any, risk that poses. Dubbed "xenotourism", it is understood New Zealand's first stem cell transplant recipient, Willie Terpstra, is among them. "That was also a xenotransplantation. It counts because, though it was human cells taken from an aborted fetus, it had to be grown on mouse cells. "Even if xenotransplantation was stopped in New Zealand, would you have to adopt draconian measures such as compulsory quarantine or make people own up at the border?" <>The process offers potential treatment for diabetes and Parkinson's Disease and an alternative to human donated organs, which are in short supply. Animal organs could be a solution if we could prevent rejection. Other forms of xenotransplantation involve cells or external means. "If you've got acute liver failure, what's been tried experimentally is taking blood from people with liver failure and putting it through a chamber containing pig cells, which works like dialysis, acting as a kind of bridge till they get a (human) liver transplant," Dr Wilkinson says.

Pigs are the "favored" donor animal but they carry a virus in their dna, Dr Wilkinson says. "It's part of their genes, meaning you can't avoid having it by bringing them up carefully. There were concerns it could create a new and horrible type of virus in humans. But there's enormous controversy about the likelihood of that. Some people say it's of the order of being hit by a large asteroid. Others say the risk might be low but it's a risk of a very, very bad thing happening."

Islam and Judaism forbid eating pork but some accept xenotransplantation on the basis that humans have a higher status than animals so animals can be used to improve our welfare. "Muslim views regarding a pig heart or brain, they're against that but if you talk about heart cells or brain cells, they're not so worried. The cells are somehow easier to accept," Professor Elliott says. <>The Bioethics Council "dialogue" groups meet again next month to revisit these issues. The council has an open mind, Dr Wilkinson says. "One thing that I am surprised about is the lack of people saying, `Ooh yuck, I can't allow that, it's just horrible.' From my point of view, that's good. What we're getting are reasons as opposed to gut reactions.

INHALED INSULIN APPEARS SUCCESSFUL IN EUROPEAN TRIALS

DATE: April 29, 2005

Diabetics in Europe could soon be using inhaled insulin rather than injections as test results show it is safe and effective in controlling blood sugar levels, a British diabetic charity announced last week. Drug makers Pfizer and Sanofi Aventis have already applied for licenses to market inhaled insulin throughout Europe as well as the United States, Pfizer said. A spokeswoman for the Diabetes UK charity said the medicine could be available throughout Europe in a year or two.

Test results announced at the Diabetes UK annual conference in Glasgow showed that for people with Type 2 diabetes already on tablets, inhaled insulin gave better blood glucose control than taking more tablets as treatment. Among patients with Type 1 diabetes, four years of inhaled insulin treatment combined with a daily long-lasting insulin injection was shown to be effective with no serious side effects. Anthony Barnett, professor of medicine at the University of Birmingham who has been involved in the research, said: "Our hope is that inhaled insulin will provide more choice, making it easier for people with diabetes to stay healthy." Douglas Smallwood, chief executive of Diabetes UK, said that "since insulin was discovered in the 1920s injections have been the only option. That can be difficult for some people. "Many attempts have been made to come up with new treatments and at last we appear to be close to success," he said. "While it will not be suitable for everyone this could make a real difference to the daily lives of many people with diabetes," he added.

Pfizer and Sanofi-Aventis Group are seeking approval to market Exubera, their brand of inhaled insulin powder, from both the European Medicines Evaluation Agency as well as from the US Food and Drug Administration, Pfizer said. Pfizer said Exubera is being developed for patients with Type 1 and Type 2 diabetes through a collaboration between Pfizer and Sanofi-Aventis. The two companies have entered into a global agreement to jointly develop, promote, and where permitted by law, jointly manufacture inhaled insulin, it was reveled in a statement published last month. Pfizer said Exubera, a dry powder form of insulin that is inhaled into the lungs prior to eating, using a specially designed inhalation device, has been studied in more than 3,500 patients, some for over seven years.

It said it is estimated that nearly 180 million people worldwide suffer from diabetes, and the number is expected to rise to 300 million people in the next 20 years. More than half of people with diabetes remain uncontrolled or poorly controlled and are at risk for common complications such as heart disease, stroke, kidney failure, nerve damage and blindness.

LIFESCAN ALERTS USERS WORLDWIDE OF POTENTIAL PROBLEM WITH ITS BLOOD GLUCOSE METERS

DATE: April 22, 2005

LifeScan of Milpitas California, the manufacturer of blood glucose testing meters, reported that it is initiating a worldwide notification to all users of its OneTouch Ultra, InDuo and OneTouch FastTake meters that it may be possible for users to misinterpret their blood glucose results.

All three affected meter systems were originally designed to allow patients to select one of two units of measure to display their test results. This selection is typically determined by the standard used by the country in which they live.

LifeScan, a Johnson & Johnson subsidiary, found that it was possible for consumers, in the course of setting their meter’s date and time, to accidentally change the unit of measure and thereby misinterpret their blood glucose results. Very rarely, an event such as dropping a meter while in use can cause a brief power loss, which may also unexpectedly change the unit of measure and/or the code number used to program the meter to match a particular vial of test strips. In the U.S., milligrams per deciliter (mg/dL) is the standard of measure for blood glucose testing systems. In many other countries, millimoles per liter (mmol/L) is used. The company said that users should continue to test their blood glucose but is instructing patients to confirm their meter's unit of measure and the code number each time they test.

It also is conducting a worldwide notification program consisting of letters to registered users and health care professionals, and also special instructions inserted in each package of test strips. Patients with these products are advised to contact the company to confirm their meter is set to the proper unit of measure. LifeScan said it has notified the FDA and other regulatory agencies around the world of this voluntary action. The products are distributed worldwide, primarily through retail pharmacy and mail-order channels. The FastTake meter is sold under the EuroFlash, SmartScan and PocketScan brand names. Shipments of test strips for these systems are not affected, the company said. <>From the beginning of 2004 through mid-March of this year, LifeScan said it has received 40 worldwide reports of adverse events associated with these meters being set to the incorrect unit of measure. These events have generally consisted of temporary periods of high or low blood sugar, some of which required medical attention. An accidental change in the meter’s unit of measure can contribute to people with diabetes misunderstanding their test results and managing their diet or medication in a way that can result in temporary periods of high or low blood sugar. According to the company, there are an estimated 4.7 million users of these products worldwide. <>To further address this issue, LifeScan reported that it has temporarily stopped shipment of versions of the OneTouch Ultra, OneTouch FastTake and InDuo systems that allow users to change the unit of measure. It is implementing a product modification for new OneTouch Ultra Meters that will prevent users from inadvertently switching their meter’s unit of measure. Shipments of the meters with this modification are expected to begin within a week. The timing to resume shipments of InDuo and OneTouch FastTake meters has not been determined.

SOURCE-Medical Device Daily

ISLET TRANSPLANT WITHOUT IMMUNE SUPPRESSANTS APPEARS SUCCESSFUL

DATE: April 15, 2005

AmCyte, Inc., announced the transplantation of the first Type 1 diabetic patient in North America to receive islets without long-term immune suppression.

The transplant took place on February 22 in Canada at the Toronto General Hospital. The patient experienced no complications during the minor 20-minute surgical infusion. The patient was released from the hospital 3 days after the procedure and is resting at home.

The transplanted islets are protected from rejection by the patient's immune system with AmCyte's novel microencapsulation technology. About the size of a pinhead, each clear gel bead contains multiple islets, and floats freely in the patient's abdominal cavity. The capsules are permeable so that nutrients and glucose can get to the islets, and secreted insulin from the islets can get out into the blood. "At this point we are very happy that the patient is doing well," said Oliver Foellmer, AmCyte's director of Business Development. "The clinical trial represents a new generation of islet transplantation technology and is part of a multi-prong clinical trial strategy to bring a treatment for diabetes to the market."

"We are excited to contribute this important step towards a treatment for diabetes without the health risks of immune suppression," said Wen G. Tsang, Sr. VP R&D. "In conjunction with our Adult Stem Cell Regenerated Islet Program, we look forward to being able to address both the limitations of immune suppression and islet supply."

Approved by Health Canada, the clinical study's primary endpoints are safety assessments of the procedure at 180 days with secondary endpoints looking at the function of the transplanted insulin producing islet cells. This study's conservative dose of islets may not be sufficient to fulfill the patient's insulin requirements. Future studies would address the issues of appropriate dosing of encapsulated islets.

The trial is being conducted at the Toronto General Hospital (TGH) of the University Health Network in collaboration with TGH's Multi Organ Transplant (MOT) Program.

OIL PALM TRUNK FIBER SHOWS FUNCTIONAL FOOD POTENTIAL

DATE: April 08, 2005

Oil palm trunk fiber has shown potential as a functional food ingredient and may help manage and lower the risk of diabetes, colon cancer, heart disease and obesity, according to preliminary research results presented at the Experimental Biology conference in San Diego this week, reports Jess Halliday.

Extracted from the trunk of the oil palm, a tree indigenous to West Africa and cultivated in Malaysia and Indonesia, oil palm trunk fiber has been shown to be an excellent antioxidant and is thought to promote glucose metabolism and manage healthy cholesterol levels in sufferers of type 2 diabetes.

To establish its potential as a source of dietary fiber, Dr Alex Schauss, director of natural and medicinal products research for the American Institute for Biosocial and Medical Research in Tacoma, Washington, fed oil palm trunk fiber to rats and measured the fecal bulking, water retention capacity, colonic water load and dry matter, which gives an indication of soluble and insoluble fiber content.

The results were compared with those produced by three other fibers under the same conditions: American Association of Cereal Chemists’ wheat bran, Danisco’s Fibrex and, as an international reference, IHWB wheat.

“We were really surprised by the results. In every variable and parameter, oil palm trunk fiber proved superior to all other sources,” Schauss told NutraIngredients-USA.com.

Most surprising, however, were the results of the antioxidant assays. Oil palm trunk fiber was found to have an unusually high ORAC (oxygen radical absorbance capacity) value – 93, compared with 94 for cranberries, 92.6 for wild blueberries and 49 for raspberries.

A randomized, double blind, placebo controlled study is also currently underway and although the full results will not be available until June, the indications are that it could have the ability to promote glucose metabolism and manage healthy cholesterol levels.

Schauss explained that oil palm trunk fiber is very light and can absorb a lot of water without congealing. It can withstand extremes of temperature and moisture conditions during food processing, and could have a wide range of applications in foods where fiber might usually be added, such as yogurts, breads, pastries and other products using durum wheat.

Production methods used in Malaysia also mean it can be certified organic – a status verified by Schauss by testing for 38 different pesticides and herbicides.

Although it is not yet available in the US, a cereal made using oil palm trunk fiber has been introduced in Malaysia through Sukhe International, the Selangor Daru Ehsan-based company which extracts the trunk fiber using a patented process and is funding ongoing research.

The success of oil palm trunk fiber in the functional foods market would mean Malaysia can generate revenue out of a waste product that has, until now, proved problematic.

Malaysia produces 50 percent of the world’s palm oil and has 3 million hectares of the trees under cultivation. Every year, 9 million trees become nascent and must be cut down, with saplings planted in their stead.

However anti-pollution laws introduced in the 1990s mean that the 7 million tones of dead wood, which is of little use for furniture making, cannot be burned. When left on the ground it has been found to make the soil infertile.

The Malaysian government first started looking into uses for the wood in the 1980s, when it asked a Japanese scientist to investigate its possible use for animal feed. He established that it could be used as a nutritional source, but it was not until 1996 until the patented production process, which makes it palatable for humans, was developed, sparking Schauss’ research.

A case history for the fiber has already been established in Malaysia, involving 400 human subjects suffering from constipation, over several years. According to Schauss, 100 percent of participants reported an improvement in bowel function improvement.

Schauss expects the full complement of studies, which also include toxicology and dosage investigations, to be completed by the end of 2005, after which it will be submitted for self-affirmed GRAS status and registered with the FDA as a new dietary ingredient.

Once the regulatory obligations have been fulfilled, oil palm trunk fiber could reach the market as a functional food and dietary supplement ingredient as early as next spring.

CONTINUOUS GLUCOSE MONITORS COULD BE HIGHLY COST-EFFECTIVE

DATE: April 01, 2005

Devices to continuously monitor the blood-sugar levels of diabetes patients are still largely in research labs, but the New England Healthcare Institute says it's time to figure out how to get the machines approved by regulators and paid for by insurance companies. The institute, a nonprofit health policy organization focused on enabling innovation in healthcare, said such devices will dramatically improve the health of diabetic patients. To speed early adoption of the glucose-monitoring devices, advocates and regulators need to establish accuracy standards so they don't get bogged down in evaluations by the US Food and Drug Administration.

"Our study shows that this is a highly cost-effective and valuable technology," said Valerie Fleishman, vice president of the institute. "It has the ability to dramatically improve the lives of millions of diabetes patients. Our overview of the technology for the next three to five years highlights the barriers that could impede adoption of this technology."

Continuous glucose monitors have the potential to dramatically change daily life for many of the roughly 18 million Americans with diabetes. Many patients have to monitor their blood-sugar levels several times a day, pricking their fingers to get a drop of blood to put on a test strip. Some patients aren't conscientious about monitoring.

"While it says on the finger-stick testing supply boxes that they're painless, trust me, they're not," said Dr. Aaron Kowalski, scientific program manager for the Juvenile Diabetes Research Foundation, an advocacy group that funds research. "They hurt, and most people with diabetes are kids."

More important, the continuous monitors provide more detailed information. Instead of a single snapshot of blood-sugar levels, continuous monitoring can show whether glucose is rising or falling, and how quickly. That can have a big impact on how patients dose themselves with insulin to manage the glucose level.

Keeping glucose within certain boundaries prevents low-blood-sugar episodes that can cause blackouts, and it eliminates periods of high blood sugar, which are linked to the development of serious complications such as blindness, loss of circulation, kidney failure, and heart disease.

"This tool will allow people to control their blood sugar more tightly and will reduce their risk for complications," said Dr. Howard Wolpert, director of the insulin pump program at the Joslin Diabetes Center in Boston.

While there are continuous glucose monitors that doctors use in their offices, several firms are rushing to develop a home version for patients. Medtronic Inc. of Minneapolis sells a system for about $2,000 that patients, under the supervision of a physician, can wear for up to three days. It measures glucose levels every five minutes with a sensor placed under the skin. The firm's next device, intended for patients, would monitor glucose continuously and sound an alarm if it falls outside a set range.

Another Medtronic device, scheduled to begin testing this summer, would combine glucose monitoring with an insulin pump, moving closer to the automatic glucose management provided by the pancreas in healthy people.

Sontra Medical Corp. of Franklin is developing its own device in conjunction with Bayer AG, the German drug giant. Sontra's approach uses one device to create micropores in a patient's skin. Then a second device is attached to the permeable area, providing glucose readings for up to 24 hours. The firm predicts it may be ready for the home market by 2008.

The New England Healthcare Institute urges the FDA to establish new accuracy standards to judge the coming generation of machines. In addition, the institute said the FDA hasn't developed labeling to show that a continuous monitoring device is an approved replacement for standard finger-stick monitoring. Both steps could speed adoption of the new devices when they become available, the institute said.

This article prepared by The Boston Globe. To subscribe to the newspaper, go to www.boston.com

GUARDIANS OF THE CAMEL MAY HOLD KEY TO DIABETES RESEARCH IN INDIA

DATE: March 25, 2005

A community of camel breeders tucked away in Rajasthan India could hold the key to one of medical science's great quests: combating diabetes. The Raikas, a nomadic tribe, have stood out for their flashy turbans and striking bracelets, but population studies have thrown up a remarkable new fact. Not a single case of diabetes has ever been reported in the tribe. Even as India braces itself to become the epicenter for diabetes by 2025, the Indian Council of Medical Research (ICMR) has commissioned two massive studies to find out what protects the Raikas from the disease. The decision was taken after data collected from ICMR's regional center in Jodhpur, the Desert Medicine Research Center, confirmed the Raika phenomenon.

Unlike villages with different tribal populations, the Raikas have had no case of diabetes and have showed amazing tolerance to glucose, said Dr N. K. Ganguly, Director General, ICMR. "While studies reveal no case of diabetes has ever been reported in the tribe the reasons are still unknown,'' said Dr Ganguly, adding, "ICMR will try to find out the reason.'' ICMR has decided to pursue two separate lines of inquiry: the first will try to determine whether some gene gives the Raikas immunity from diabetes. "Maybe there's a gene in their body that is protective in nature,'' said Dr Ganguly.

The second study will examine the role of camel milk. "The only way in which the Raikas are different from the rest of us in India is that they still drink camel milk,'' said Dr Ganguly. In fact, Raikas are known in Rajasthan as "guardians of the camel'', even having been entrusted with the maharajahs' herds. They are also said to have never sold a female camel outside their community and frown on selling camel milk, saying it's like "selling a son''. The Raikas, who live in the hills as well as desert areas of Mewar, Godhwar, and Malva, are a nomadic people who travel continuously with herds of sheep and camels. Raika men from the hills stand out with their large red turbans while the women wear colorful clothes and antique ivory bracelets. Even previous studies have pointed to the protective effect of camel milk - though this time ICMR has a clear lead to follow. A small, month long study of people with Type1 diabetes in Britain (which has not been formally published) has already suggested that drinking almost a pint of camel milk daily improved blood glucose levels, reducing the need for insulin. Camel milk does seem to contain an insulin-like protein, which appears capable of passing through the stomach without being destroyed. The stomach's acidity would normally destroy insulin, which is why developing oral insulin has been such a challenge. "Camel milk is not just about milk proteins, there are many other ingredients in it. We have to look at the specifics,'' said Dr Ganguly.

GENZYME AND VIACELL FORM PARTNERSHIP IN SEARCH OF A CURE TO JUVENILE DIABETES

DATE: March 18, 2005

Stem-cell upstart Viacell Inc. and Genzyme Corp. are joining forces to develop a therapy they say has a chance of curing juvenile diabetes within years. Terms of the deal between the Cambridge firms has not been disclosed, but Genzyme said it will pay for development of the experimental treatment until it is ready for human clinical trials, estimated to take two years. "This is the only thing I see that has a potential to cure Type 1 diabetes," said Marc Beer, Viacell's chief executive.

Viacell's approach is to take pancreatic tissue from cadavers and isolate the stem cells that mature into islet cells. Using unique methods, Viacell grows those cells into enormous quantities of islet stem cells. Doctors then inject the cells into the main vein entering the liver. The cells are believed to take up residence in the liver -- and perhaps other organs -- and begin generating insulin.

Viacell is working to develop cell-based therapies that sidestep the controversy over stem cells, which are tiny, undifferentiated cells with the ability to develop into any type of body tissue. Many scientists use stem cells harvested from days-old embryos, such as those left over from fertility treatments. Many abortion opponents object to this technique because they say scientists should not destroy a potentially viable fetus for medical purposes. Viacell seeks to develop treatments from newborns' umbilical cord blood, which is rich in stem cells.

Viacell's brash attitude toward an intractable disease that affects 1 million to 2 million US patients elicited plaudits and caution in the diabetes community.

"The concept is very exciting and we hope it works," said Dr. Robert Goldstein, chief scientific officer of the Juvenile Diabetes Research Foundation International, the largest charity that funds research into Type 1 diabetes. "We look forward to seeing how this industry collaboration can expedite the time to clinical trials."

Others questioned whether Viacell and Genzyme can get their experimental therapy -- which has so far been tested only in mice -- into the clinic within two years.

"Two years is very optimistic," said Susan Bonner-Weir, a senior investigator in islet transplantation and cell biology at the Joslin Diabetes Center in Boston. "To get into the clinic they have to know what they are isolating, they have to be able to grow the stem cells, and they want to be sure the cells" function properly in the body, secreting insulin as needed based on blood sugar levels.

Researchers have worked for years to develop ways of replenishing islet cells in diabetic patients. Hundreds of diabetics have received islet cells under a special drug regimen that prevents the patients' bodies from rejecting the foreign cells. But there aren't enough donated organs to treat more than a tiny sample of patients.

"If you could create limitless amounts of tissue and convert it to islet-like clusters, you could treat many more patients," said Dr. Joel Habener, chief of the Molecular Endocrinology Lab at Massachusetts General Hospital. Viacell licenses Habener's patented research as the basis for the experimental diabetes treatment.

Under the terms of the deal with Genzyme, the firms will collaborate until the treatment is ready to enter human clinical trials. Then, Genzyme has first rights to negotiate a second deal to bring the drug to market. If those talks fail, Viacell can proceed on its own or with another partner.

FOOD & WALKING REFERENCE JOURNAL JUST RELEASED

DATE: March 11, 2005

Fountain Valley, CA - Pocket Reference Journals Incorporated has launched it's latest pocket sized guide entitled, "Step On It! A Food & Walking Journal." It was originally developed for the U.S. Army as part of a diet and fitness promotion- but its also a good information source for people with diabetes.

"Step On It" was written by several health care professionals including a registered dietitian and a podiatrist. It covers a month long system with room to record both dietary intake as well as steps taken on a daily basis. This handy guide is meant to be used in conjunction with a pedometer. It was patterned after the President's Challenge and The Ten-Thousand Healthy Steps Initiative, so it is an easy read and encourages its users to be proactive. The journal, with its 48 pages, measures a mere 3 1/2 by 6 1/2 inches, so it is easily carried along for an entire days activities.

The journal includes health information and covers subjects such as: you are what you eat, cholesterol, and weight management. It includes pages to record your weight, and resource pages to access web sites and various associations. Recordings are done on a meal by meal basis, taking into account calories, proteins, fiber, water, etc., and of course the number of steps taken daily. For additional information and availability visit: www.pocketreferencejournals.com

PROGRESS SEEN IN NEW METHOD OF ISLET CELL TRANSPLANT

DATE: March 04, 2005

Doctors at the University of Minnesota may have found a way around an obstacle in the effort to perfect transplants of islet cells in people with Type 1 diabetes. Such transplants usually succeed only if islet cells from the pancreases of two or even three donors are used - a significant drawback, given the scarcity of donor organs. But now, in a trial of eight patients at the University of Minnesota, in Minneapolis, doctors have managed successful transplants of islet cells, which are needed to produce insulin, with the pancreases of single donors.

The use of anti-inflammatory drugs that are normally used to treat arthritis seems to have enabled many more of the transplanted cells to survive, said Dr. Bernhard J. Hering, director of the islet transplant program at the University of Minnesota. Patients were given these drugs before surgery to dampen the inflammation that otherwise destroys as many as half of transplanted islet cells in the first 24 hours, Dr. Hering said. The doctors also cultured the donated islet cells in the laboratory for two days, rather than transplanting them within hours of isolating them from the donor pancreas. This step appears to give the islet cells greater resilience, Dr. Hering said. The results of the trial were recently reported in The Journal of the American Medical Association. "This is really a long-awaited development, if it can be reproduced, because it means that the efficiency of islet cells is being increased," said Dr. R. Paul Robertson, scientific director of the Pacific Northwest Research Institute, a diabetes research center in Seattle. Dr. Robertson was not involved in the trial.

Diabetes researchers hope islet-cell transplants, which can be done almost as easily as a blood transfusion, in less than an hour, will one day free many people with Type 1 diabetes from the need to inject themselves with insulin several times a day to control their blood sugar. But refining the procedure has not been easy. Among the first patients to have successful transplants five years ago, most are using insulin again-though not as much as they needed before their transplants.

Type 1 diabetes, sometimes called juvenile diabetes, occurs when the body's immune system destroys the insulin-producing cells in the pancreas, which are contained in tiny structures called the islets of Langerhans. An estimated one million people in the United States have Type 1 diabetes. Although it is possible to transplant the entire pancreas, the risk of death is great enough that the operation is rarely done in people who do not also need a kidney transplant because of diabetes-related kidney failure. Islet-cell transplants are less invasive and less dangerous.

Islet cells, which make up about 2 percent of the pancreas, can be isolated from cadaver pancreases and then transplanted through a catheter into the recipient's liver. They cannot be placed into the pancreas, because that organ is too vulnerable to inflammation. When islet-cell transplants were first performed in humans, in the 1980's, they were rarely successful. But five years ago, surgeons at the University of Alberta in Edmonton adjusted the combination of immunity-suppressing drugs that are used to prevent rejection of the new cells and achieved successful transplants in eight patients. Since then, the Edmonton protocol, with some variations, has been used on about 500 patients worldwide, said Dr. James Shapiro, director of the islet-cell transplant program at the University of Alberta, who designed the protocol. "We've come a long way in a really short time, and I think islet transplantation is here to stay," Dr. Shapiro said. "It's still far from perfect, however."

A total of 73 patients have now received islet-cell transplants in Edmonton, most of whom have had the procedure twice. One year after transplant, 82 percent of patients need no insulin injections. After three years, however, that number falls to about 50 percent, Dr. Shapiro said. But after five years, he said, it appears that only 15 percent will still be independent of insulin. "It appears that some of the grafts are failing, but it is not a complete failure," Dr. Shapiro said. "Some of the transplanted cells are still producing insulin." Some of the cells may succumb to the anti-rejection drugs. Or perhaps the autoimmune reaction that caused the patient's diabetes kills them, Dr. Shapiro said. In January, working with surgeons in Kyoto, Japan, Dr. Shapiro accomplished the first islet-cell transplant from a living donor. A 27-year-old woman with Type 1 diabetes was given islet cells that had been isolated from half of her mother's pancreas. Such transplants would expand the supply of donor cells. But some experts are wary of risks to donors.

WASHINGTON UNIVERSITY STUDY MIGHT YIELD OBESITY KEY

DATE: February 25, 2005

Fat burning is touted as the key to weight loss, but it may also link obesity and diabetes, research from Washington University suggests. Daniel P. Kelly, director of the Center for Cardiovascular Research at the university, and his colleagues were studying the heart when they made a discovery that could provide new understanding for how diabetes develops in overweight and obese people. The results of their study appeared recently in the journal Cell Metabolism.

The researchers noted that when fat gets into the heart, the organ stops burning sugar for energy. "There's this yin and yang between fat and sugars," Kelly said. Normally, cells use a sugar called glucose for energy, but they may also use fatty acids as less efficient fuel sources. When cells stop burning sugar and switch exclusively to fat fuel, blood sugar levels rise and insulin stops working. Those are two hallmarks of diabetes.

Kelly and his colleagues discovered that a molecule known in short as PPAR-alpha (its full name is peroxisome proliferator-activated receptor-alpha) acts in muscle cells as a fuel-source switch. The switch is thrown when animals - mice in Kelly's research - and perhaps people take in more calories than they can use and become obese. Fat cells store the excess calories as fatty acids. But "at some point the reservoir is full. You can only expand your fat tissue so much," Kelly said. The body may begin storing fat in tissues, such as muscle and liver, where it doesn't belong, he said. And when the fat spills over into muscle, PPAR-alpha gets going. The molecule helps muscle cells bring in and burn fatty acids, and shuts down sugar consumption. "It's telling the muscles 'don't listen to insulin anymore. We don't need to burn sugar,'" Kelly said. The result is high blood sugar and insulin-insensitive cells. In other words, a step toward diabetes.

The scientists genetically engineered two different types of mice - one type that made excess PPAR-alpha in their muscles and another that lacked the molecule. The researchers found that mice that overproduce PPAR-alpha become diabetic even though they are thin. That's because their muscle cells become fat-burning machines that ignore insulin and glucose. Conversely, mice lacking PPAR-alpha were prone to growing heavy, but they seemed to be protected against getting diabetes. That could mean that drugs to block the action of the molecule could prevent diabetes, Kelly suggested. The results are a mixed blessing, said Sam Klein, director of the Center for Human Nutrition at Washington University. Klein was not involved in the research. "In terms of obesity, this is a cure. In terms of diabetes, this is a cause," Klein said.

No one knows if the mechanism also works in people. The mice in the study still had active pancreas cells, so the research did not address the full picture of diabetes, Klein said. But the study may offer some clues about one reason why 65 percent to 90 percent of diabetics are also overweight, Klein said. Not everyone who is obese will develop diabetes - about 15 percent of obese people are diabetic - but overweight and obesity are risk factors for the disease. It is rare for someone who is of normal weight to get Type 2 diabetes, the form once known as adult-onset diabetes, Klein said. The new study contradicts some of the conclusions of earlier studies with mice and is likely to be "provocative," Klein said. "It makes us more confused about what we thought we knew before," Klein said. But in scientific circles, that's good news. Follow-up studies could help determine the steps that lead to diabetes in obese people and find ways to stop the disease from developing, he said.

FOR FIRST TIME, LIVE DONOR USED IN ISLET TRANSPLANT

DATE: February 18, 2005

A Canadian (Edmonton, Alberta) surgeon who pioneered insulin-cell transplants to treat diabetes oversaw a medical team in Kyoto, Japan, as they performed the world's first transplant using a living donor.

Under the supervision of Dr. James Shapiro, Japanese surgeons removed part of the pancreas from a 56-year-old woman, extracted insulin-producing cells called islets and successfully transplanted them into the woman's 27-year-old daughter. Shapiro leads a team at the University of Alberta that developed islet transplants under what is known worldwide as the Edmonton protocol. This past week the university announced that the Japanese transplant took place January 19. Both women are doing well, Shapiro said in an interview. Being able to use living donors could allow many more patients to get transplants sooner. As well, the quality is much better coming from a living donor than from the donated organ of a dead person, he said.

"I think it is a dramatic step forward," Shapiro said, adding he anticipates being able to start living donor transplants in Edmonton within months, once guidelines are developed. Currently 50 to 70 patients across Canada are waiting for islet transplants and some of them must wait longer than two years, he said.

NEW PATCH TECHNOLOGY MAY SOON END DIABETES TEST MISERY

DATE: February 11, 2005

A Revolutionary new skin patch that checks glucose levels every 60 seconds could provide a completely pain-free way of monitoring diabetes. The high-tech patch performs round the-clock measurements and beams the readings to a handheld monitor, no bigger than a mobile phone. The device, which is expected to be available in the U.K. later this year, does away with the daily routine of painful finger-prick tests to measure changes in glucose. It is also hoped it will allow diabetics to control their glucose levels more easily, reducing the long-term risks of heart disease, blindness and kidney damage. Additionally, the patch is programmed to sound an alarm if blood glucose rises or falls to dangerous levels. <> Diabetes affects around 1.8 million people in the U.K. The disease develops when the body's insulin production fails, so the amount of glucose in the blood is too high.

Pain-free glucose testing systems are something scientists have been striving to achieve for many years. <>One device already available is a watch that tests blood sugar levels every 20 minutes over a 12-hour period. Called GlucoWatch, it uses a tiny electric current to draw glucose out of the skin on to a special gel, before giving an instant reading. But while this device is not intended to replace regular blood tests, the newest patch technology mentioned above is believed to be so accurate it may replace finger-prick samples. Called the Freestyle Navigator, it has been developed by U.S. firm Abbott Laboratories. A miniature sensor is first implanted just under the skin on the upper arm or tummy by the patient, using a specially-designed spring-loaded device. Over the top of this goes a patch that is about the same size as a sticking plaster, containing a tiny transmitter. The sensor constantly detects glucose levels in the body's interstitial fluid which circulates between cells - and the transmitter sends the information to the handheld monitor, which is small enough to be carried in a pocket or purse. The manufacturer hopes to get European marketing approval later this year.

Source material for this article: Financial Times Information Limited

EARLY TREATMANT OF DIABETES URGED

DATE: February 04, 2005

A pair of physicians groups this week recommended increasingly aggressive treatment for newly diagnosed diabetes patients.

While lifestyle changes such as losing weight, exercising and watching the diet are often recommended for people with Type 2 diabetes, the new recommendations urge physicians to treat the disease aggressively early, often with two or more drugs.

The goal is to quickly get blood sugar levels as close to normal as possible, said Dr. Harold Lebovitz of SUNY Downstate Medical Center in New York.

In addition, people at high risk for developing diabetes should be screened starting at age 30, the American College of Endocrinology and the American Association of Clinical Endocrinologists said. "If we don't get them diagnosed early we miss an opportunity to prevent complications later in life," said Dr. Jaime A. Davidson of the University of Texas Southwestern Medical School in Dallas.

Complications from diabetes can include heart and nerve disease, eye damage and amputation of limbs.

The recommendations focus largely on Type 2 diabetes, the more common form of the illness, in which the body either doesn't produce enough insulin, or doesn't use it correctly. Type 1 diabetes, in which the body simply doesn't produce insulin, always requires treatment with drugs.

The groups estimate that more than 20 million Americans are diabetic, though as many as one-third don't know it. In addition, they said 41 million are believed to have pre-diabetes, an impaired sugar tolerance that can lead to diabetes. "The reason we are here is because we have a lot of work to do," Davidson said in announcing the recommendations.

ISLET CELL TRANSPLANT OFFERS NEW LIFE FOR 52-YEAR-OLD ACTOR FROM COLORADO

DATE: January 28, 2005

Last Halloween, Steph skipped the candy corn and instead went for 400,000 islet cells, injected into a vein near his liver. On Thanksgiving, Steph got not cranberries - but another 400,000 islet (rhymes with pilot) cells.

In December, just in time for Christmas, Steph got his final dose of islet cells. And suddenly, the insulin highs and sugar lows that have made his life a living hell for 23 years are nearly gone. "Holy gotchamoley!" said Steph, 52, an actor who lives in Parker Colorado. "It means the world; it means everything to me." Steph is apparently the first person in the Rocky Mountain region to receive an islet cell transplant, an experimental procedure aimed at bringing stability to diabetics who can't regulate their blood sugars. Because the procedure is experimental, Steph worries that his insurance carrier might drop him if they knew, so he requested that his last name not be used. Some 18 million people in the United States, 6.3 percent of the population, have diabetes, according to the American Diabetes Association. The annual economic cost of diabetes is $132 billion, or one of every 10 U.S. health care dollars, says the association.

Steph has Type 1 diabetes - his pancreas doesn't produce insulin, which is necessary for the body to use sugar to fuel its cells. Islet cells occur in clumps, like islands in a sea, and comprise just 1 percent of the cells in the pancreas. But they're the cells that tell the body when to produce and secrete insulin, so they are essential to well-being. The more common Type 2 diabetes usually begins in adulthood and has a strong link to obesity. With Type 2, either the body does not produce enough insulin or the cells ignore it. For most of the last 23 years, Steph has had to inject himself with insulin six or seven times a day, whenever his blood sugars were too high and he started feeling as if he were walking through quicksand. Often, he gave himself too much and he would get hyperactive, the signal that he needed to eat peanut butter, crackers, juice or potato chips - a combination of quick-acting and slow-acting sugars that brought him back into balance. Four years ago, Steph got an insulin pump. Instead of preparing a needle several times a day, he only had to push a button on the pump whenever he felt the need for insulin. But he still couldn't control the highs and lows. Sometimes he just didn't want to give himself the insulin he knew he needed. He's had car accidents in the past that he says were the result of hitting a high behind the wheel. The danger he posed to himself and others made him an ideal candidate for islet cells, said Dr. Alexander Wiseman, a transplant physician at University of Colorado Hospital.

The first islet cell transplant was done four years ago in Edmonton, Alberta Canada. A study of 36 islet cell recipients found that 19 remained insulin independent a year after the procedure, said Dr. James Shapiro, director of the program in Edmonton. Of the 17 who still need insulin, seven of those have derived some benefit and improvement in quality of life. A whole pancreas transplant is another option, but the pancreas is a fragile organ, and typically just 10 percent are suitable, he said. So, Steph got on the list for islet cell transplant. "I got the call in the middle of the night on Halloween eve," Dr. Wiseman recalled. An organ donor had just died and his pancreas couldn't be used, but might be suitable for harvesting islet cells. A five person team that is on call 365 days a year sprung into action, injecting the pancreas with a collagenase to break it down. It took them seven hours to harvest the islet cells from the pancreas and get them into a small sterile tube. With the help of diabetes specialist Dr. Peter Gottleib, an interventional radiologist, and a team of nurses, DR.Wiseman prepared Steph for the procedure. A needle poked through the skin in Steph's abdomen and went into a vessel next to his liver. A catheter slid in, the needle came out, and the islet cells dripped in from an IV bag.

When it was over, a Band Aid protected the BB-sized incision. The second opportunity to harvest and inject came on Thanksgiving Day, and the third came last month. Steph will have to take anti rejection medication the rest of his life, which will leave him more vulnerable to infections and can cause mouth ulcers, high blood pressure, high cholesterol and gastro- intestinal problems. But so far, "we've seen zero side effects in Steph," Dr. Wiseman said. He was back on the insulin pump for a couple of weeks to give the islets a rest. After that, however, they should be ready for full action on their own.

For diabetics who have good control over their blood sugars, islet cell transplants probably aren't worth the trade-offs, Dr. Wiseman said. Still, the waiting list for the transplant is growing weekly, he said. "We'll never have enough cadavers to meet demand," he said. For his part, Steph hopes he has seen the last of the days when, once or twice a day he'd slow to a crawl and couldn't raise his arms until he got another dose of insulin. "I'll be able to drive anywhere and not have to worry about it now," he said. "This means everything." .

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