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Year-long clinical trial begins
Six people are about to receive pig islet transplantations for the first time, as a New Zealand company called Living Cell Technologies (LCT) begins a year-long Phase I/IIA clinical trial in Moscow, Russia.
The islet cells are encapsulated in alginate, a gelatinous seaweed extract that allows the islets to release insulin in response to blood glucose, but prevents the body’s antibodies from reaching the islets. As a result, toxic immuno-suppressants theoretically aren’t necessary.
About 25 milliliters of the tiny capsules will be implanted around the liver and spleen of each patient during two operations, spaced six months apart. LCT will be using islet cells from newborn piglets of a special bio-certified pig herd that was isolated on Auckland Island for 200 years. The pigs are free of viruses, bacteria, and parasites.
The clinical trial will occur at the ANO Institute of Biomedical Research in Moscow and will be carried out according to US Food and Drug Administration (FDA) standards. LCT hopes to run similar trials in New Zealand later this year, followed by Phase II trials in the US if permission is forthcoming. That may not be the case, though, because the FDA is tough to satisfy when it comes to pig purity.
LCT has completed trials with diabetic mice and primates to establish the safety and effectiveness of its islet capsules. The results showed that the islet capsules were well-tolerated and led to a reduction in average insulin requirements for primates with diabetes. LCT projects that its process will eventually cost $25,000, as opposed to the $300,000 that islet transplantation now runs.
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