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Posts with tag Living Cell Technologies

First successful transplant for DiabeCell

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?

Green Light for DiabeCell Phase 1

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.

Pig Islets 10 Years and Counting

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.

Early arrival of New Zealand diabetes vaccine

It's a g'day for children prone to developing diabetes in New Zealand. A revolutionary treatment to prevent the development of type 1 diabetes was slated to begin in 10 years. The 10 year waiting period was due to a ban created to prevent animal-to-human diseases. Thankfully, in light of this proposed vaccine-it has been lifted and trials may soon be underway.

Living Cell Technologies was granted the license to manufacture its pig cell products for humans. The license is the first in a three-step process towards obtaining approval for human clinical trials in New Zealand, beginning as early as next year. The groundbreaking vaccine involves an injection of cells from a newborn pig. The cells are coated with a gel to protect them from the human immune system. The cells then secrete protective proteins responsible for the repair and protection of cells.

Australia is known for breathtaking landscapes, playful kangaroos and the narcoleptic koala. With the expected results of this discovery, it will someday soon be a land free of type 1 diabetes. That's another natural beauty to add to the list.

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