Six people are about to receive pig islet transplantations for the first time, as aNew Zealand company called Living Cell Technologies (LCT) begins a year-long PhaseI/IIA clinical trial in Moscow, Russia.
The islet cells are encapsulated in alginate, a gelatinous seaweed extract that allowsthe islets to release insulin in response to blood glucose, but prevents thebody’s antibodies from reaching the islets. As a result, toxicimmuno-suppressants theoretically aren’t necessary.
About 25 milliliters of the tiny capsules will be implanted around the liver andspleen of each patient during two operations, spaced six months apart. LCT will beusing islet cells from newborn piglets of a special bio-certified pig herd that wasisolated on Auckland Island for 200 years. The pigs are free of viruses, bacteria, andparasites.
The clinical trial will occur at the ANO Institute of Biomedical Research in Moscowand 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 IItrials 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 andeffectiveness of its islet capsules. The results showed that the islet capsules werewell-tolerated and led to a reduction in average insulin requirements for primateswith diabetes. LCT projects that its process will eventually cost $25,000, as opposedto the $300,000 that islet transplantation now runs.