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?

Circumstances of confusion invalidated a Diamyd clinical trial to protect insulin-producing cells in diabetes patients. This confusion amounts to a speed bump, but Diamyd intends to press on.

The company admitted that the Phase II clinical trial of its gene therapy had been botched following a mix up over which patients received the drug and which got placebo. Diamyd is a vaccine based on GAD65, a major factor for diabetes due to an autoimmune reaction. The company designed the vaccine to reduce the need of insulin injections and prevent the destruction of beta cells that produce insulin in the pancreas. Also, by protecting these cells, it may allow them to regenerate in a non-autoimmune environment, and possibly set the stage for a cure of the disease.

Anders Essen-Möller, CEO of Diamyd, said: "Was the drug mixed up? We do not know. Could there be a mix-up at some other times in the study? Yes it is possible, but that is not certain." Essen-Möller is determined not to let the mistake ruin the vaccine's progress towards approval. Essen-Möller also said he believes that the invalidation of the trial will not adversely affect any ongoing meetings with potential partners.

Novocell is the first company to use polyethylene glycol (PEG) to encapsulate clusters of insulin-producing cells. This biocompatible substance allows glucose and insulin to pass freely through the coating while preventing the body's immune system from destroying the islets.

The encapsulated islets release human insulin through natural mechanisms in response to the recipient's blood glucose. The islet cells used in this study are isolated from human cadavers. The implant procedure is performed under local anesthesia and the encapsulated islets are injected into a surgically formed micropocket in the subcutaneous tissues of the thigh or lower abdomen of the recipient. The patients received temporary low dose cyclosporine (50-100 ng/ml 12hr trough) and did not receive any other form of immunosuppression.

At the American Diabetes Association 66th Annual Scientific Session in June -- Novocell announced the progress of the study. No adverse events had occurred -- no news is good news. In addition, the company also has the fortune of existing in California - where they can prosper on further stem cell research. Novocell has developed a process that efficiently converts human embryonic stem cells into insulin-producing cells. Novocell believes this study will demonstrate the safety and efficacy of the encapsulation technology that can be used with the unlimited source of insulin-producing cells developed from stem cells to treat patients with diabetes.

Living Cell Technologies has been given the go ahead to conduct clinical trials of its DiabeCell diabetes product in New Zealand.

DiabeCell is a porcine islet cell product for the treatment of insulin- dependent diabetes. The pig cells are injected into the body without any immunosuppressant drugs. The cells produce insulin to help regulate blood glucose levels appropriate to the amount of glucose detected in the blood stream of the diabetic recipient.

The Medical Director of Living Cell Technologies explains that DiabeCell offers considerable advantages over other available treatments in addition to the fact there is no need for immuno-suppressive drugs. Anther problem of islet transplants is the strain on the supply of islets. This is not a problem with the DiabeCell because their supply of cells derive from natural biocertified pig herds, unlike human organ donors.

LCT's application is to conduct the clinical trial of its DiabeCell product on 8 long standing Type 1 diabetics. The clinical trial is expected to be approximately 12 months in duration. This will then be followed by a trial on a larger scale. The trial will be conducted at a New Zealand hospital and involves the simple injection of encapsulated islets into the abdomen of the diabetic patients. It is anticipated that the trial would start by the end of 2007.

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.