Xenotransplant trial in diabetes w/o immunisation

Australian-listed company to run world’s first xenotransplantation trial in diabetes without immunosupression

A product made from natural neonatal pig islet cells encased in capsules is to offer new hope to people with type 1 (insulin-dependent) diabetes.

In a world first, Australian-listed company, Living Cell Technologies (LCT), is poised to start a Phase I/IIa trial for patients with type 1 diabetes using its porcine pancreatic cell product, DiabeCell®, without using toxic immunosuppression drugs.

DiabeCell® allows insulin to be released from the alginate-encapsulated[i] cells, but prevents the body’s immune system from attacking the cells. The encapsulated cells (about the size of a pin-head) are injected into the body and produce insulin in response to the levels of glucose in the blood, mimicking the normal insulin release that occurs in people without diabetes and helping to regulate blood glucose levels in people with type 1 diabetes.

DiabeCell® offers considerable advantages over other available treatments: there is no need for immunosuppressive drugs (which are associated with unpleasant side effects)[ii] and insulin-producing cells from LCT’s natural bio-certified pig herds are readily available, unlike organs from human donors.

The 12-month phase I/IIa trial will include six participants with type 1 diabetes and will take place at a specialist organ and xenotransplantation hospital in Moscow, Russia. There is currently a moratorium on performing xenotransplantations in Australia.[iii]

“As a company at the forefront of the xeno cell therapy industry, LCT is already 12 months ahead of its competition,” said the company’s Chief Executive Officer, Dr Paul Tan.

“This is the only human clinical trial of its kind approved anywhere in the world. It recognises LCT’s thorough pre-clinical testing of the product in animal models, which showed no adverse safety effects and a significant reduction in insulin requirements,” said Dr John Court, scientific advisor to LCT and expert on adolescent diabetes.

LCT has completed trials with diabetic mice and primates to establish safety and the ability to treat type 1 diabetes. The results showed that DiabeCell was well-tolerated and led to a reduction in the insulin requirements on average for primates with diabetes.

The animals given empty biocapsules needed more insulin than before the transplants. No adverse reactions were apparent from the initial or repeated transplants.

Photos of pigs and animations are available upon request

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About Living Cell Technologies: www.lctglobal.com

Living Cell Technologies Ltd (ASX: LCT) develops live cell therapy products to treat life threatening human diseases. The ASX listed, vertically integrated company focuses on developing treatments where healthy living cells are injected into patients to replace or repair damaged tissue, without requiring the use of toxic drugs to prevent rejection. The company’s product portfolio focuses on treatments for people with insulin-dependent diabetes and neurological disorders. The company owns a specialised biocertified pig herd for a safe, reliable source of cells for treatment.

[i] Alginate Encapsulation – Cells are passed through a seaweed derived gel to coat the cells. The result is a micro-capsule (about the size of a pin-head). Nutrients can pass through the capsule to the cells and insulin from the cells can pass into the body. Antibodies cannot reach the cells inside the capsule, preventing rejection by the patient’s immune system.

[ii] Immunosuppression – Immunosuppression or anti-rejection drugs are currently used in cell transplantation and organ transplants. These drugs have to be taken for life, to ensure that the transplant is not rejected by the patient’s immune system. The drugs have long-term side effects from a weakened immune system, such as ulcers, diarrhea and ovarian cysts (Ref: Ryan E et al. Diabetes Vol 4, Jul 2005).

[iii] As the result of a report from its Xenotransplantation Working Party, the National Health and Medical Research Council (NHMRC) instigated in 2004 a 5-year moratorium on clinical research involving the transplantation of animal cells or organs to humans, ie xenotransplantation.

Most western countries have decided to proceed cautiously with strictly regulated xenotransplantation trials, in view of the chronic shortage of suitable organs from human donors. A small number of xenotransplantation clinical trials are under way in the US and Europe.

ENDS

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