September 30, 2007

Porcine Cell Transplantation

by

Dr. Robert Elliot
Topic: Porcine Cell Transplantation

NEW YORK
Sunday, Sept. 30
9pm eastern time

NEW ZEALAND
Monday, October, 1
2pm

DennisHK says to (20:04): I have to have my big thanks to you and all yr scientists from LCT

DennisHK says to (20:05):Dr Elliot, is the Russia trial going on well ?

Dr. Bob Elliott says to (20:05):Two patients have had their first transplant, one in June and one four weeks ago.

DennisHK says to (20:06):Are those islets functioning well ?

Dr. Bob Elliott says to (20:06):Both are well, with no side effects. They are showing preliminary signs of function that is, insulin dose is reducing

DennisHK says to (20:06):thanks God

Dr. Bob Elliott says to (20:06):At least as well as expected

DennisHK says to (20:07):how long are those patients dx?

Dr. Bob Elliott says to (20:07):3 months for 1, four weeks for the other

DennisHK says to (20:07):my daughter is a newly dx, for 1 year

gina says to (20:07):oh so they are newly dxd

gina says to (20:08):are you mainly focusing on people that have been just diagnosed?

Dr. Bob Elliott says to (20:08):sorry, the first patient for 10 years, the second one 23 years…

DennisHK says to (20:08):oh

gina says to (20:08):oh

gina says to (20:09):i think we should give people a few more minutes to come in

gina says to (20:10):this way you wont repeat answers

DennisHK says to (20:10):Dr Elliot, are doctors also employ the US FDA specs ?

Dr. Bob Elliott says to (20:11):Yes, we actually go beyond what the FDA requires.

DennisHK says to (20:11):gd

DennisHK says to (20:11):In NZ, still waiting Minister approval ?

Hope_cnd says to (20:12):What are the major possilbe side effects, please?

Dr. Bob Elliott says to (20:12):Yes, still waiting patiently… shouldn’t be a problem

Dr. Bob Elliott says to (20:13):Hi Hope – side effects – surgical problems, we use laparoscope, infection, then unforeseen pig infection

Hope_cnd says to (20:13):Will the procedure be available for children also (assuming everything goes well)? How young?

Dr. Bob Elliott says to (20:14):Eventually yes, but need to do a lot of adults first. It would be ideal to do children as they accept transplants better.

Ellen says to (20:15):I’m sorry I’m late…did you say where the islets are implanted?

Dr. Bob Elliott says to (20:15):HI Ellen – into the peritoneal cavity

sugarless says to DennisHK (20:15):Are anti rejection drugs used?

Dr. Bob Elliott says to (20:16):no

sugarless says to DennisHK (20:16):How are they avoided?

Ellen says to (20:16):When will the results be forthcoming for the first person in Russia who recently received the porcine islets?

Dr. Bob Elliott says to (20:16):The islets are coated with a seaweed product which makes them invisible to the immune system.

Hope_cnd says to (20:17):Are the islet cells supposed to multiply in the capsules?

Dr. Bob Elliott says to (20:17):Very preliminary results for the first patient in Russia will be announced very shortly.

gina says to (20:17):Is that the same kind of thing DR. BERNIE TUCH was doing with seaweed extract?

jroanire says to (20:17):I understand the encapsulation wears off after 211 days. After the encapsulation wears off, exposing the porcine islets directly to the peritoneal cavity, are you concerned with the possibility of cross specials infection with PERV

Dr. Bob Elliott says to (20:17):They probably do Hope

Dr. Bob Elliott says to (20:18):Similar Gina, but much better

jroanire says to (20:18):Sorry. Cross species infection with PERV, porcine endogenous retroviruses that adapt to human hosts?

Dr. Bob Elliott says to (20:19):Jroanire – we have one human patient transplanted in 1996 who still has functional pig islets in his peritineal cavity. PERV does not seem to be an issue.

dacajana says to (20:19):Trials can be expensive. Does LCT have enough financial support at this time to complete the research?

Dr. Bob Elliott says to (20:20):dacajana – we are very short of cash, but hopefully Father Christmas is not far away

jroanire says to (20:20):So far so good, but caution because that is only one person.

DennisHK says to (20:20):Dr Elliot, I understand you have an US office . Do you also plan to do the trial in US ?

jeffry says to (20:21):Dr. Elliot…it seems some in the US rsearch community don’t yet support your research…why do you think that is….”not invinted here” or what?…

sugarless says to (20:21):How many patients to date have been included in the trial?

Dr. Bob Elliott says to (20:21):after we have completed Russian and NZ trials we will apply to FDA with this data

DennisHK says to (20:21):thanks

Dr. Bob Elliott says to (20:22):Hi jeffry – some do support it.

jeffry says to (20:22):ok..thanks

Dr. Bob Elliott says to (20:22):sugarless – 6 in Russia, 8 in NZ

DennisHK says to (20:22):I think a lot of xeno support in US, and getting more & more ………

Ellen says to (20:23):Any idea if FDA will be receptive? Is it politics as usual?

rjommp says to (20:24):Dr do you expect resistance from drug companies as success in eliminating any form of diabetes will greatly reach into the financial coffers of the companies?

Dr. Bob Elliott says to (20:24):Dennis & Ellen – we have been thrilled to see others taking up the pig islet encapsulation in the US. The more that do, the more we are likely to be able to cope with the 30 million needing transplantation

dacajana says to (20:24):I’ve read that the coating is very effective against most of the immunine system, but that one part (telemears?) can get through and damage cells. Is there any truth to that?

libbyd says to (20:24):Are you looking for this treatment to bring complete euglycemia? Or,to decrease Insulin needs dramatically?

Dr. Bob Elliott says to (20:25):rjommp – initially some resistance but they will of course join if the trials are successful

Dr. Bob Elliott says to (20:25):dacajana – the coating stops cells and antibodies but some of the smaller molecules can get through.

DennisHK says to (20:25):very much agree, when LCT proves xeno is the most ideal solution

Dr. Bob Elliott says to (20:26):libbyd- our final goal is to eliminate the need for insulin, however, better control would be a worthwhile objective

dacajana says to (20:26):If the cells slowly degrade, how often will patients need to ‘tank-up’ on fresh islets?

Ellen says to (20:26):Do you think it’ll be necessary to use the special pigs that you are raising in such sterile conditions forever, or do you think some of those conditions may be able to be relaxed down the road?

libbyd says to (20:26):absolutely!

Hope_cnd says to (20:26):The expectation is that the capsules should be replaced on a regular basis for the rest of life? Thank you.

Dr. Bob Elliott says to (20:27):dacajana – we don’t know the answer to this yet…I anticipate 6 to 12 months initially, but this could be much longer, particularly subsequently,

DennisHK says to (20:27):I think those have to be tested in those clinical trials

jroanire says to (20:27):Does the success of your transplant depend in any way on whether or not the patient has elevated GAD 65 antibodies before transplant as successful islet transplantation was effected by this in the past? Or does the coating take care of this problem?

Dr. Bob Elliott says to (20:28):Ellen – I think the restrictions on pigs will relax.

Dr. Bob Elliott says to (20:28):jroanire – antibodies won’t matter

Ellen says to (20:28):What is the criteria for patients to be in the trials? Do you have BMI requirements? Absence of complications?…

libbyd says to (20:29):Will children ever be used in clinical trials?

Dr. Bob Elliott says to (20:30):Criteria – consenting adults, 10 or more years diabetic, ready willing and able, no advanced complications

Dr. Bob Elliott says to (20:30):libbyd – i am a pediatrician – yes children eventually will receive treatment

dacajana says to (20:31):Certain cells (Sertoli) are said to ‘turn-off’ the immune system. Could those be used to extend the life of the iselts?

DennisHK says to (20:31):Dr Elliot – Will those with less years of dx(say 5 yrs) suitable for xeno treatment ( maybe later) ?

jaden42 says to (20:31):Is this the same treatment that was given to a woman written about in Womans World who claimed she was cured of her diabetes after cell transplant?

Dr. Bob Elliott says to (20:31):dacajana – this has been tried in diabetic animals with success, and in humans in Mexico. Some very interesting research going on in Canada.

Ellen says to (20:32):Assuming (and I’m oh so hopeful) that NZ gives permission to go forward, will you accept trial participants from the US? Or do you need to have the patients carefully monitored in NZ? (Medical tourism)

Dr. Bob Elliott says to (20:32):dennis – yes eventually

jeffry says to (20:32):Dr, Elliot…has the JDRF expressed any interest in supporting your reserach?

Dr. Bob Elliott says to (20:32):jaden42 – don’t know this one

Dr. Bob Elliott says to (20:33):ellen – initiall we will have to use NZ patients

libbyd says to (20:33):Considering where you are now, and where you need to go – What time frame are we looking at to get this to the market?

Ellen says to (20:33):What if one was an exchange student for a year ;-)? (you don’t have to answer that)

jroanire says to (20:33):Yes, about the humans in Mexico…. how did the humans transplanted with islets by Dr. Rafael Valdez fare? Are they now on insulin? If on insulin, has euglycemia been somewhat restored?

jaden42 says to (20:33):It was supposedly done in Philadelphia, PA. I called about it but the doctors had moved on to another type of trial because they told me that the cell transplantation was not perfected yet

Dr. Bob Elliott says to (20:33):jeffry – dialogue with JDRF has not been productive in terms of supporting the clinical trials. They want further primate studies done.

Ellen says to (20:34):Thankfully they don’t want more NOD mouse studies (sorry couldn’t resist)

Jim’s Mum says to DennisHK (20:34):LOL Ellen (Mel here)

jeffry says to (20:35):thanks..but won’t succes with the human trials mean that primate studies are moot?

Dr. Bob Elliott says to (20:35):libby – in Russia, commercial availability is likely to be swift. In NZ it will depend on how effective the trial is – a further pivotal study will be needed – say 2010 for NZ

Dr. Bob Elliott says to (20:36):jroanire – re Mexico – 2 patients were reported to come off insulin briefly. Half of the patients appeared to produce pig insulin over some years.

Dr. Bob Elliott says to (20:36):jeffry – excactly!

jeffry says to (20:36):tks

DennisHK says to (20:37):Dr Elliot – Do you mean only NZ patients would be included in yr planned NZ trials ? what abt later treatment ?

jroanire says to (20:37):Why didn’t Dr. Valdez continue to inject islets into his patients as the effects wore off?

Dr. Bob Elliott says to (20:37):Dennis – only NZ patients for the first 8. Possibly others would be okay later.

DennisHK says to (20:38):that is very good

jeffry says to (20:38):Dr Elliot…just curiious…prior to current DNA produced himan insulin when insulin was made form pigs were the pigs raise in sterile environemt

Dr. Bob Elliott says to (20:38):jroanire – approval for his trials was withdrawn

Dr. Bob Elliott says to (20:38):jeffry – no

Ellen says to (20:38):Dr. Elliott, what would be legitimate reservations a potential porcine islet recipient would need to consider before agreeing to participate?

jroanire says to (20:39):Yes, now I remember….

Dr. Bob Elliott says to (20:39):Ellen – objections to use of animals, assurances about potential injection with unknown viruses.

dacajana says to (20:40):Dr. E., If LCT is ‘best-in-class’ with encapsulated pig-islets, a joint effort using Sertoli cells from Canada sounds like a match made in heaven … any chance of that?

Hope_cnd says to (20:40):So, if everything goes well, do you expect the procedure to be commercially available by 2012 for adults? How about children? Will the delay be significant?

Dr. Bob Elliott says to (20:40):dacajana – Dr David White and I are collaborators.

jeffry says to (20:40):so..then if you get to a point of using non sterile pigs then would it be reasoanble that pigs that are killed today for meat around the world could be used for pig islets?

Dr. Bob Elliott says to (20:41):Hope – 2010 for adults. Delays for children should be minimal

DennisHK says to (20:41):Great , great news

Hope_cnd says to (20:41):Thank you, Dr. Elliott.

Dr. Bob Elliott says to (20:41):jeffry – pigs do have some pretty nasy diseases. I would not want cells from some of the pigs I have seen.

jeffry says to (20:41):ok

jroanire says to (20:42):Three years! I’ll be counting the hours. What can we do to help facilitate your research in the United States?

Dr. Bob Elliott says to (20:43):jroanire – keep the critics at bay

jroanire says to (20:43):Buy stock in LCT?

Dr. Bob Elliott says to (20:43):It would be quite illegal for me to suggest such a course!

molly says to (20:43):I am no longer going to donate to JDRF.

Ellen says to (20:44):I am so very grateful for your efforts Dr. Elliott. Honestly in all these years I have really not been particularly excited that euglycemia will be restored without toxic immunosuppression and now there seems to be a real hope that this can happen.

jroanire says to (20:44):We may all be rich!

DennisHK says to (20:44):Dr Elliot, – much big thanks to you and all the LCT scientists …

Hope_cnd says to (20:44):Are some of the cells expected to die at transplantation? How long should they be able to survive in a human body? What are main concerns about their suvivability?

jeffry says to (20:45):Dr. Elliot..same question..i know you can’t recommend any buy stock in LCT but assuming A US resident wanted to on thier own..can you suggest how it would be done or point to url on lct website on how to do it?

Dr. Bob Elliott says to (20:45):Hope – I think the majority do die quite soon after transplantation. It’s the hardy survivors that may go on for many years.

jroanire says to (20:45):Wouldn

jroanire says to (20:46):Buying stock in the company is a way of supporting research

Dr. Bob Elliott says to (20:46):jeffry – see our website – basically, ask your stockbroker to invest through the ADR programme

jeffry says to (20:46):ok..tks

rjommp says to (20:46):I’ll take a vial of the hearty ones Dr 🙂

Hope_cnd says to (20:46):Dr. Elliott – could you give us an idea of the cost of the procedure?

molly says to (20:47):a lot

Ellen says to (20:47):Are you experimenting with techniques to prevent the initial destruction upon implantation?

jeffry says to (20:47):Dr. Elliot same question RE JDRF..has the US ADA approached you about supporint your research?

Hope_cnd says to (20:47):Molly, a lot is relative… Are there more precise numbers?

molly says to (20:48):I’ve heard $25,000 for one year…

Dr. Bob Elliott says to (20:48):Hope – at the moment, very expensive. The pigs alone cost about NZ$14,000 per patient. Our pilot cellplant is economically very inefficient. Costs will come down in time to be competitive with orthodox diabetes treatment.

dacajana says to (20:48):Does buying LCT stock (LVCLY.PK) provide funds for research or are donations far more effective?

Dr. Bob Elliott says to (20:48):Ellen – yes. secret as yet…

Dr. Bob Elliott says to (20:49):jeffry – No

jeffry says to (20:49):ok..tks

jroanire says to (20:49):Who would one donate to? To make sure the scientists receive funds?

Dr. Bob Elliott says to (20:49):dacajana – donations obviously are more effective but buying stock is useful too

molly says to (20:50):ADA & JDRF are showing no signs of support for LCT?

jroanire says to (20:50):ADA, LOL?

Ellen says to (20:51):When do you anticipate receiving word on approval for trials in NZ?

molly says to (20:51):are they helping fund their research? I don’t know…

Dr. Bob Elliott says to (20:51):jroanire – we do not have a charitable trust. If one was set up it could accumulate donations and buy treasury stock, that is straight from the company rather than another individual

Hope_cnd says to Dr. Bob Elliott (20:51):
If the capsule wears out after 200 days, is there any danger for the patient if new capsules will be transplated every year? Can the porcine cells damage in any way the host after they “escape” the capsule?

Dr. Bob Elliott says to (20:51):Ellen – about a month

Dr. Bob Elliott says to (20:52):ADA & JDRF do not fund this research

Ellen says to (20:52):What a shame.

molly says to (20:52):yep

molly says to (20:52):I am disgusted.

Dr. Bob Elliott says to (20:53):Hope – the Russian trial involves a second transplant six months after the first. I do not anticipate any problems.

Hope_cnd says to Dr. Bob Elliott (20:53):Even if that keeps going year after year?

Dr. Bob Elliott says to (20:54):Hope – we have done four and five transplants in monkeys with no diminishing effect or any adverse effects.

Hope_cnd says to Dr. Bob Elliott (20:54):Thank you, Dr. Elliot.

MeadowLark says to (20:54):Is this only for type 1’s?

Ellen says to molly (20:54):Were those monkeys diabetic from streptozoticin? (sp?)

Dr. Bob Elliott says to (20:55):Meadowlark – so far only Type 1, but insulin dependent type 2 would follow.

Dr. Bob Elliott says to (20:55):Ellen – yes

MeadowLark says to (20:55):ahhh 🙂 I’m type 2 and really struggling.

jroanire says to (20:55):One more question: Once the encapsulation wears off the porcine isets, the islets that remain may be somewhat effective. How do you control the strength of the new procine transplant? Is hypoglycemia a potential problem?

dacajana says to (20:56):Is there a Russian agency with exclusive rights to provide this procedure (assuming trials go well)?

Dr. Bob Elliott says to (20:56):Meadowlark – hang on in there. A severe type 2 is not much different to a Type 1

Ellen says to 20:56):Are the trial recipients wearing any CGMS to monitor their blood glucose levels?

Dr. Bob Elliott says to (20:56):jroanire – the transplanted islets autoregulate ie do not cause hypoglycaemia.

MeadowLark says to (20:56):I’ve been on Metformin, now Januvia. Neither are lowering my morning numbers at all. I’m staying too high for my 2 hours after meal testing also.

Dr. Bob Elliott says to (20:57):dacajana – not yet

Dr. Bob Elliott says to (20:57):Ellen – yes

dacajana says to (20:57):if you build it, they will come

Ellen says to (20:57)::-) I’m so excited to see the data!

Dr. Bob Elliott says to (20:58):Meadowlark – you sound like a failed oral treatment type 2 or a misdiagnosed type 1

MeadowLark says to (20:58):All my family members have passed on.. they were all type 1. I”m surprised I to diagnosed type2.

Ellen says to (20:59):Are we right to be extremely enthusiastic about this, or should we temper our enthusiasm? I think you’ve been very good about not hyping this out of control as so many other researchers have done.

Dr. Bob Elliott says to (20:59):Meadowlark – phew! get your GAD antibodies done

Dr. Bob Elliott says to (20:59):Ellen – early days but I can scarcely contain my excitement.

MeadowLark says to (20:59):I’m from 150 to 190 in the mornings. then by lunch down to 110 to 130 Diner numbers around 85 to 115 for an avg day.

Hope_cnd says to Dr. Bob Elliott (20:59):Other than the human immune system, are there other “dangers” for the porcine cells to survive in a human body?

MeadowLark says to (21:00):my c-peptide test came back at 3.9

Dr. Bob Elliott says to (21:01):Hope – I suppose you are thinking about cancer. This does seem to be an emerging problem with human islets injected into the liver. We haven’t seen anything like this.

MeadowLark says to gina (21:01):is that the same test?

jroanire says to (21:01):Meadowlark, those sound like her honeymoon numbers I was always complaining about, LOL. I would give anything for those numbers now!

Dr. Bob Elliott says to (21:01):Meadowlark – NO

rjommp says to (21:01):Dr your research is so much more tangible than the idle promises I’ve heard for the past 41 years as a person with Type One than from all the Diabetes agencies

MeadowLark says to (21:02):Thankyou

MeadowLark says to (21:02):oops

jeffry says to (21:03):Dr. Elliot..any plans to come to the us to speak.?

Dr. Bob Elliott says to (21:03):Good night and good luck !

MeadowLark says to (21:03):I’m sorry I dont understand

molly says to (21:03):Thank you Dr. Elliott!

MeadowLark says to (21:03):Thankyou Dr Elliot

dacajana says to (21:04):Thanks Dr. E.

jroanire says to (21:04):Wow! Thank you Dr. Elliot.

DennisHK says to (21:04):Thank you Dr Elliot

molly says to (21:04):yes

Hope_cnd says to (21:04):Thank you!!! Really appreciated! God speed, Dr. Elliott. I am sure the the Nobel price will be yours if …

dacajana says to (21:04):Have any of you been to The Islet Foundation Public Message Forum http://www.islet.org/forum/wwwboard.htm

Ellen says to gina (21:04):That was AWESOME. Thanks Gina and Jon for providing this opportunity to chat with Dr. Elliott. I hope we can chat with him again when the first results of the Russian recipients come in.

jroanire says to (21:05):Meadow, it was ending already. I think you should find out if you are LADA, or Type 1.5.

dacajana says to (21:05):LCT still looks like the best chance at this point

MeadowLark says to gina (21:05):I”m sorry I came late:(

gina says to (21:05):Dr. Elliot thank you so much for the chat, I really hope you will come back again.

gina says to (21:06):Everyone before you go

Hope_cnd says to (21:06):gina, jon, would the transcript be available on your website? Thank you.

rjommp says to (21:06):Night everyone 🙂

jroanire says to (21:06):Thank you, Gina, for providing the space for such informative talks.

jon says (21:06):We will get the transcript up in a couple of days

dacajana says to (21:06):Yes, thanks for setting this up

MeadowLark says to gina (21:06):Thankyou Gina, I’l try to be more careful watching th etime to start.

Hope_cnd says to (21:06):Thank you for setting it up. Bye

Jim’s Mum says to (21:06):Thanks so much for this! Excellent!

DennisHK says to (21:06):Excellent , Gina. Thanks

jon says (21:06):Thanks everybody for coming!

gina says to MeadowLark (21:07):BEFORE YOU GO MAKE SURE YOU JOIN THE DTF SOCIAL NETWORK SITE www.diabetestalkfest.ning.com and join the Chatfest group for upcoming chats.

dacajana says to (21:07):When will the next one come?

gina says to MeadowLark (21:07):SOON