Clinical trials of pig cell transplants

LCT is testing its encapsulated pig cell product DIABECELL in patients with a rare complication of type 1 diabetes called unaware hypoglycaemia. Patients with this complication are unable to tell when their blood sugar is low and may become unconscious before they realise. Clinical trials on a small number of patients with unaware hypoglycaemia have shown that the product is safe, can improve their blood sugar control and reduce the amount of insulin they need to inject.

Transcript

Bob Elliott (Living Cell Technologies) Having these ideas about cells that can regulate blood glucose better than injections is all very well but it has to be submitted to clinical trials in humans, after a lot of trials in animals, experimental animals and so on. And we started with a preliminary study in Russia to establish the safety of the procedure and were we getting any clues that this might be working. So the pig cells inside the capsules, we put in eight patients altogether in Russia, and from that, we could say, “Yes it’s safe, nothing happened.” And some of the patients showed some interesting signs that they were getting a good effect from these cells. Blood glucose levels were tighter, their insulin dose fell, and we could actually pick up pig insulin in their blood.

So then we proceeded to a formal clinical trial in New Zealand. Initially, eight patients received a single dose of these islets into the belly cavity. When I’m talking about a dose of cells, I’m really talking about the number of encapsulated islets of Langerhans from pigs we’re putting into the belly cavity. To give you some idea, a small dose we would say is 5,000 of these encapsulated islets per kilogram body weight, and that, for an average size person, is going to be up to half a million of these islets. Sounds a lot but it’s in fact in quite a small volume that would be 25 ml of encapsulated islets that have got to go into the belly cavity.

So we started with a small dose and then gave incrementally bigger doses to other patients, and initially we used patients with a severe complication of diabetes called unaware hypoglycaemia. That’s where, when their blood glucose fell, instead of feeling, “Oh I don’t feel well, I think I need something to eat, my blood glucose is too low or I better check it,” these people just suddenly become unconscious without any warning, very nasty, potentially lethal complication. And what we found is, yes, we could alleviate this nasty complication of the disease. We didn’t cure anybody from diabetes. We got lowering of the insulin requirements with improved blood glucose levels.

So we’re now armed with this piece of knowledge that we can achieve what we want to in terms of stopping this very nasty complication of unaware hypoglycaemia. We can achieve that with quite a small dose, single small dose.

Acknowledgement: PRN Films