Recently we wrote that Living Cell Technologies (LCT), a New Zealand company, was about to begin transplanting pig islets into humans in a year-long Phase I/IIA clinical trial in Moscow, Russia (“Piglet Islets Soon Tested in Humans”).
Well, now it’s begun: On June 14, 2007, the first of six patients was successfully implanted with the first of two doses of pig islets; the second dose will occur in six months.
It’s the beginning of what could be a big step forward for xenotransplantation (the transplant of foreign (xeno) parts from a non-human source into a human).
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, there is no need for the toxic immuno-suppressants usually required in transplantation.
In a ten-minute procedure, about 25 milliliters of the tiny capsules, called DiabeCells, were implanted around the patient’s liver and spleen. The islet cells inside the capsules were obtained from newborn piglets of a special bio-certified pig herd that was isolated on Auckland Island for 200 years and is free of microbiological contaminants.
The encapsulated cells have already demonstrated clinical benefit in small and large animal trials. A preliminary test in humans ten years ago also had positive results: After Michael Helyer, a New Zealander with longstanding type 1 diabetes, received an experimental LCT pig islet cell transplant, his need for insulin was reduced by 34 percent for a year. Even now the pig islets continue to produce a little natural insulin.
LCT expects its process to eventually cost $25,000, as opposed to the $300,000 that islet transplantation now runs. They hope to have it available to the public by 2012.