Govt Changes Conditions For Implanting Pig Cells In Diabetics
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Posted by JoeC on 07:18:14 2009/06/19
Govt Changes Conditions For Implanting Pig Cells In Diabetics
Friday, 19 June, 2009 - 19:38
Wellington, June 19 NZPA - Biotech entrepreneur, Living Cell Technologies Ltd (LCT), says it has accepted constraints Health Minister Tony Ryall has proposed on its plans to implant pig tissue in human patients.
Mr Ryall plans to issue a conditional authorisation for LCT's clinical trials in insulin-dependent patients at Auckland's Middlemore Hospital.
The company was developing a commercial treatment for insulin-dependent diabetes.
The company said today the minister wanted the study -- in which islet cells from piglets bred to be killed for their pancreatic tissue will be implanted in a patient's abdomen -- limited to patients with "brittle diabetes".
Brittle diabetes, also called labile diabetes, was a relatively rare uncontrolled type 1 diabetes, and people born with it frequently experienced extreme swings in blood sugar levels.
The blood sugar levels of people with stable diabetes may fluctuate occasionally, but patients with brittle diabetes are often hospitalised, miss work and have to contend with psychological problems.
LCT said the minister wanted these patients used so that the study complied with international guidelines, which required that people in such trials obtain maximum benefit possible from their participation.
Other proposed changes to the conditions were matters that LCT had agreed during a peer review process, or were procedural.
It had already changed the clinical protocol to meet the minister's requirements.
The company was given approval by the previous government in October 208 to implant cells from the pancreas of piglets in the abdomen of type-1 (juvenile onset) diabetes patients to help manufacture insulin to control their blood sugar levels.
The company has claimed that by wrapping the cells in a seaweed gel, it can allow the cells to obtain nutrient from the human body without being recognised by the immune system as porcine invaders.
The concept of the cells was the work of New Zealander Bob Elliott, who actually implanted cells in half a dozen Aucklanders over 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, 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.
The company has already tested the technology on some Russian patients near Moscow.
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