Back in 2000, researchers at the University of Alberta in Edmonton, Canada transplanted islet cells in the livers of people with type 1, known as the Edmonton Protocol. Each islet transplant required several cadaver donors. The transplants worked for awhile, but approximately 80 percent of patients required insulin after a couple years. It was assumed the transplanted cells were rejected, but new research points to a new possible culprit -- fat.

Dr. Roger Unger and colleagues of the University of Texas Southwestern Medical Center in Dallas performed the Edmonton Protocol in rats with type 1. Fat built up around the transplanted cells in only a month. The cells stopped producing insulin and the rats died after 15 weeks. Dr. Unger explained the liver creates fatty acids from food, and islet transplants in the liver are surrounded by too much fat. He proved his point by repeating the transplant in a separate group of type 1 rats, but this time the rats were on a strict diet. A third group of rats received leptin, a hormone involved in increasing metabolism and decreasing appetite. These rats had an improved response, although the Reuters story does not provide specifics. Here's the study abstract in Diabetes, but ya gotta pay for the full text article.

Bummer. You get an islet cell transplant, but still have to stay away from the Ben & Jerry's. A next step could be testing this theory in human islet cell transplants via a low-calorie, low-sugar diet following transplantation. Read more in Reuters.

The scientific community has been in a heated debate about xenotransplants (transplanting pig islets into humans). Although the procedures are showing to be effective - is the insulin secretion entirely pig? Some experts surmise that after the transplants, diabetic patients are actually able to produce some insulin on their own, after all.

The latest press release from Tissera, Inc (an Israeli-based company) made a statement that raises my hopes. It was, "By the fourth month after transplantation, the insulin dose needed to maintain near-normal blood sugar levels decreased by more than 90% in comparison with the insulin dose needed before transplantation, meaning that endogenous insulin production was predominantly responsible for blood sugar control."

The question of the origin of endogenous insulin was addressed by measurement of blood C-peptide. C-peptide splits from insulin and indicates the level of insulin secretion from the patient. C-peptide levels were measured both at baseline and in response to a sugar load, which brings about a rise in blood C-peptide. The measured C-peptide was shown to be predominantly of pig origin. So herein lies my question: is predominantly more than 50%? A type 1 diabetic has undetectable levels of C-peptide. Period. After the xenotransplant the C-peptide level is all of a sudden detectable? Could these islet transplants assist in regenerating the diabetics' own islets?

DiabeCell has successfully been transplanted into the first type I diabetes patient. This trial is testing its efficacy and safety in controlling the dangerous blood glucose levels to prevent long-term secondary complications of type I diabetes.

Living Cell Technologies has announced the successful transplant into the first of six type I (insulin dependent) diabetic patients in a world-first human clinical trial using DiabeCell. Patients in the trial will receive two low doses of the pig islet cells every six months over a 12 month period, followed by a further 12 month study, evaluating the benefits. Recipients in this first trial are given the lowest clinically effective dose to demonstrate safety. The dosing is repeated for additional clinical benefit. The company hopes to commercialize the product for general use by 2012.

DiabeCell is a pig pancreatic islet cell product that secretes insulin in response to the patient's blood glucose levels. People with type I diabetes are not able to produce their own insulin because their pancreas cells are not functioning. DiabeCell has been uniquely developed with a gel that forms a tiny capsule around the cells. This prevents the patient's immune system from destroying the transplant and does not require immunosuppressive drugs. Think of DiabeCell as bubble wrap for islets -- cool, right?

The Edmonton Protocol has been temporarily put on hold due to fears the human form of mad cow disease might infect patients.

The source of an enzyme used in transplants was reported to derive from cow brains. Transplants of these treated islets have been put on hold until a source for this enzyme can be found that doesn't use cow brains. Dr. James Shapiro, the surgeon who developed the Edmontol Protocol said, "we just decided to put the program on hold". Shapiro and his team transplant healthy islet cells into the pancreas of people with Type 1 diabetes. The healthy cells allow recipients to again begin producing insulin crucial to the body's ability to regulate sugar digestion.

The National Institutes of Health was creating a similar program in the United States when it discovered that one of the biomedical compounds that Shapiro's team has been using depends on cow brains. Roche Applied Sciences was selling the team an enzyme that allows doctors to extract healthy islet cells. But Roche was buying the bacteria that secretes the enzyme from a third company, which grew the bacteria using fat from cow brains. Roche spokeswoman Michele Beaubien said from Montreal that the enzyme is sold for research purposes only.

The more I learn these days about medicine and how it is applied to diabetes - the more I feel as though everything is for research purposes only. Don't you? As Yogi Berra said, "it ain't over till it's over". A big thanks to Dave of No Sugar Tonight for bringing this story to my attention.

In 1996 a 41 year old male (a type 1 diabetic for 18 years) was injected with biocapsules containing pig islets to regulate his blood sugar level. The transplanted cells helped reduce the patient's insulin requirement by 34% for over a year, which provided better control. By 2005 the patient's glycated hemoglobin levels (HbA1c) remained lower than the pre-transplant levels.

Ten years later, the patent contacted Living Cell Technologies to inform them that he believed the transplanted pig islets were still alive and well. After tests were conducted, it was concluded that the pig cells were (as he reported) still functioning. This proved that the LCT patented technology for xenotransplantation was effective. It allows the islets to survive at least ten years in a micro-capsule coating and continue to release insulin into the patient's bloodstream without immune suppression. After tests we conducted on the type of insulin present in the patients blood - it was with 100% certainty that it was pig and not human insulin.

LCT has significantly advanced the encapsulation process since the 1996 clinical trial and there is an even greater understanding and control over the longevity and robustness of the encapsulation process, as well as the porcine islet cells. LCT will be trialing the DiabeCell pig islet cell transplant in patients in a phase I/IIa clinical trial, expected to begin in Quarter 2, 2007. In addition, LCT is awaiting approval to conduct an additional trial in New Zealand this year with a different treatment protocol. Subsequent trials in the US or Europe are intended following initial results from these studies.

If overseas trials are coming through with flying colors - why aren't we doing this yet? C'mon USA - where's your competitive spirit? All these pigs up in Spring Point might be put to good use, after all. Oink Oink.

Just like a referee to normalize play throughout the game - DiaKine Therapeutics is developing ways to normalize the body's immune system.

The new drugs modulate cytokines, part of the body's immune system, which mistakenly attack normal organs and tissue and cause diseases such as: diabetes, multiple sclerosis and inflammatory bowel disease. Research by Dr. Nadler and his collaborators published in 2006 showed that controlling certain cytokines can arrest the progression of, or reverse, type 1 diabetes in an animal model.

The company's first product, IsletLifeLSF Media 1 is designed to improve the viability and insulin producing capabilities of harvested islet cells prior to transplant. This would potentially improve the success rate of the procedure. Additional therapeutics under development by DiaKine include: adjunct therapy to islet cell transplants, halting the progression of type 1 diabetes in newly diagnosed adults, treatment and prevention of Latent Autoimmune Diabetes of Adults (LADA), treatment and prevention of insulin requiring type 2 diabetic, treatment and prevention of diabetes complications.

It all sounds like good stuff in the works. Keep an eye on the progress and press releases of DiaKine, as well as their research partner - the Diabetes Research Institute. A lot is happening these days. What else have you seen or heard about in the autoimmune arena?