Go-ahead for pig cell trials on diabetics

Implants to begin next month

Clinical trials to implant pig tissue in insulin-dependent diabetes patients will begin next month after the Government granted approval.

Auckland biotech company Living Cell Technologies got the green light from Health Minister Tony Ryall yesterday after agreeing on revised conditions.

The trials in which cells from piglets will be implanted in a patient's abdomen now have to limit participation to patients with "brittle" diabetes. Patients will also be given more details about the process.

Living Cell Technologies chief executive Paul Tan confirmed that eight patients with type-1 diabetes would receive injections containing insulin-producing cells from Auckland Island pigs to prepare for the implants. The first transplant could take place within three months.

Diabetes is caused by too much sugar in the blood because the pancreas cannot make enough insulin. The pancreas contains clusters of cells, known as islets, that produce hormones such as insulin. People with brittle diabetes frequently experience large swings in blood sugar levels.

"We have about 200 people wanting to take part in the trials, so the interest has been amazing," Dr Tan said.

"It has been frustrating waiting so long, but when you are trying to get these things started there are always a few hurdles. This is very, very good news."

If the trials are successful he hopes to extend them to include about 30 more patients. "If we can say the results are so good in a year's time when we follow up with the first lot of patients, then we would like to extend the trial."

He said patients in a Russian trial, which began in June 2007, had been able to cut their insulin dependence by between 25 and 100 per cent.

The bid for New Zealand approval was boosted in 2007 after researchers discovered pig cells injected into Matamata man Michael Helyer in 1996 were still producing insulin.

The idea was developed by New Zealander Bob Elliott, who implanted cells in six Aucklanders more than a decade ago, before being shut down by health officials who were concerned about the potential for pig retroviruses to move into the human population.

The new trials will be run by John Baker, clinical director at Middlemore Hospital, with four of the patients receiving a dose of 10,000 islet cells, followed by four patients who will each have a higher dose of 15,000 implanted.

Living Cell Technologies has built a $2.5 million piggery at Awarua, near Invercargill, to breed the pigs in strictly controlled conditions.

Diabetes New Zealand estimates 15,000 Kiwis have type-1 diabetes, including 3500 children and teenagers.

- © Fairfax NZ News