[comment caption=Do you think these trials should go ahead?]Biotech company Living Cell Technologies (LCT) says today's ministerial approval for clinical trials in which pig cells will be put into type-1 diabetics is a major milestone.
"We are now able to formally access volunteers and intend to start work on this with Middlemore Hospital immediately," LCT's medical director Professor Bob Elliott said.
Prof Elliott began the research over a decade ago, but his injections of pig cells into people in 1996 and 1997 were interrupted by the Government after scientists expressed concern about the potential for disease-causing pig viruses to be introduced to the human population.
Australia bans such research, and New Zealand trials need ministerial approval. Today's approval is the first under the Medicines Act.
The company, which is listed on the Australian stock exchange (ASX), keeps its pigs in quarantine in New Zealand.
"Approval to begin our clinical trial .... makes it easier for LCT to obtain approvals in other countries," US-based LCT chief executive Robert Caspari said.
Islet cells from the pancreas of piglets are coated with a seaweed gel and implanted in the abdomen of diabetes patients to manufacture insulin and help control their blood sugar levels.
The implants, to be marketed as DiabeCellB, are already being tried in Russian patients, but a NZ trial is expected to carry greater weight with the United States Food and Drug Administration (FDA).
The DiabeCellB trial in Russia started last June with a low dose programme but current patients are receiving double that dose.
Four of the eight Middlemore patients will be given the same dose now being used in Moscow, and the rest will receive one 50 percent stronger.
The trial will be conducted by Dr John Baker, clinical director of diabetes treatment at Middlemore.
Diabetes New Zealand president, Mike Smith, of Napier, said the organisation was pleased the minister had made a decision.
"If it's going to be a breakthrough for people with type-1 diabetes, then it can only be good, as long as all the protocols are followed," Mr Smith said.
He wanted to see the evidence on which Mr Cunliffe based his decision, and would like to see the treatment's effectiveness recorded publicly.
Professor Patrick Manning, of Dunedin, president of the New Zealand Society for the Study of Diabetes (NZSSD), which represents diabetes clinicians, said that proving pig cells safe and effective could overcome severe shortages of human cells.
The society wants the clinical trial to meet criteria set by the International Xenotransplantation Association (IXA), but said it had been given no indication of whether that was happening in the case of LCT.
"We are pleased that there's going to be an independent data monitoring board, but we would like the monitoring not only to be for safety issues, but the effectiveness of the procedure," Prof Manning told NZPA.
The Wellington-based Sustainability Council, which raised questions over whether the LCT trials could potentially pass on serious infectious diseases, also called for the efficacy of the treatment to be adequately proven.
The think-tank's executive director, Simon Terry, said "key sections of the health bureaucracy had been recommending approval" in spite of caution on the part of other researchers.
The Health and Disability Commissioner, Ron Paterson, had previously said that a "collective consent" should be obtained before the trials started because it was the community which carried any risk of infection.
Mr Cunliffe required a favourable peer review by a leading international expert nominated by the Ministry of Health.
