Linking Diabetics Coast 2 Coast
Islet Transplant chat with Dr. Bob Elliott of Living Cell Technologies (LCT)
(04:23):Welcome to Dr. Bob Elliott Chat , Dr. Bob Elliott !
Dr. Bob Elliott says to (04:23):
Well thank you
chelsea says to (04:24):
welcome dr bob
Gina says to (04:24):
Hi Dr. Elliott
Jon says (04:24):
Hi Dr. Elliott
Ellen1366 says to (04:25):
Good morning Dr. Elliott.
Gina says to (04:30):
Ok everyone
Gina says to (04:30):
we are going to get started
Gina says to (04:30):
remember
Gina says to (04:30):
to give Dr. Elliott a chance to answer your questions
Gina says to (04:31):
Start asking!
Dr. Bob Elliott says to (04:31):
It is a beautiful spring morning here in nz
Jon says (04:31):
Dr. Elliott, could you give us a brief description of what you are working on?
Dr. Bob Elliott says to (04:32):
Encapsulated piglet islets to treat (hopefully) cure diabetes
Ellen1366 says to (04:32):
Hi Dr. Elliott. Since it's so obvious there will never be enough human cadaver islets to restore
Euglycemia in people with diabetes, why do you think it's been so difficult to get approval for trials in NZ, Australia, US....?
Dr. Bob Elliott says to (04:32):
it is the animal source that is the problem
Dr. Bob Elliott says to (04:32):
pigs have bad press!
Paula says to (04:32):
why so
Heidi98 says to (04:33):
what sort of diseases could they pass on to humans
Dr. Bob Elliott says to (04:33):
fear of the unknown, and all of the theoretical stuff that came up about endogenous retrovirus
Hope says to (04:33):
Hello Dr. Elliott - could you please give us an idea as to when the human trials are going to start in US?
Dr. Bob Elliott says to (04:33):
106 diseases that pigs CAN pass on to humans, that we know of, but we make sure that our pigs don’t have these. PERV is a theoretical risk only
Dr. Bob Elliott says to (04:34):
first FDA application will be lodged before xmas
Dr. Bob Elliott says to (04:34):
Matters are out of our hands after that
Jan3103 says to (04:34):
Dr. Elliot, how secure is the encapsulation coating the islets? Could the coating wear off in ten or
twenty years, exposing the patient to the porcine islets?
Dr. Bob Elliott says to (04:34):
yes the coating could wear out, but the cells would then be destroyed together with any viruses they may contain
Monmon says to (04:35):
what about encapsulated immunosuppressive near to the implanted cells?
AllieB2 says to (04:35):
(people underestimate the power of the human immune system)
Dennis Leung HK says to (04:35):
Prof , will the US trial any big difference to that doing in Russia ?
Dr. Bob Elliott says to (04:36):
pig cells are destroyed immediately on contact with human serum together with any retrovirus
Dr. Bob Elliott says to (04:36):
US trial - dose will be bigger and there will be more people in the trial
Jan3103 says to (04:36):
However, once the coating wears off, the patient will be exposed to the islets, however briefly?
Dr. Bob Elliott says to (04:36):
yes
toddnsharla says to (04:36):
how can one get involved in the trial?
Dr. Bob Elliott says to (04:37):
The Barbara Davis Centre in Denver will be conducting the trial under the direction of Prof. Boris Draznin
landileigh says to (04:37):
I am an "Other", pancreas destroyed by Acute Pancreatitis due to duct obstruction. I have no c-peptide, would I be a candidate for islet transplantation?
Hope says to (04:37):
accumulated worn out capsules could be of any danger to the body?
Ellen1366 says to (04:37):
Would you be so kind as to update us on the trials going on in Russia right now, what you've learned so far, what you may want to change....?
Dr. Bob Elliott says to (04:38):
no, the amount of alginate is extremely small and is quite inert
Monmon says to (04:38):
Do we need to have an immunosuppressive near to the implanted cells capsule?
Gina says to (04:38):
slow down everyone
Jan3103 says to (04:38):
So the patient would be briefly exposed to any retroviruses present, after which islet and retrovirus (if any) would be destroyed?
Dr. Bob Elliott says to (04:39):
9 transplants done so far, without immunosuppression, three patients have had two transplants. so far, average dose reduction maximum has been about 50%
Dr. Bob Elliott says to (04:39):
and hemoglobin HbA1c reduced by 1.7% average
Bonnie1797 says to (04:39):
Hello Dr. Elliott, can you please share the process of transplants and how often one would need to have it done?
Jan3103 says to (04:40):
Great news!
Dr. Bob Elliott says to (04:40):
two patients have been going for a year, with dose reduction of 28% and 56% respectively
Gina says to (04:40):
that is great
Dr. Bob Elliott says to (04:40):
the cells are inserted via a laproscope into the abdominal cavity, currently under general anesthetic, this takes about 10mins
Ellen1366 says to (04:40):
What was the average baseline A1c prior?
Monmon says to (04:40):
do you mean insulin dose reduction?
Dr. Bob Elliott says to (04:41):
yes
Dr. Bob Elliott says to (04:41):
average
baseline was about 8%
Ellen1366 says to (04:41):
Any side effects?
Jan3103 says to (04:41):
And you are not using the maximum amount of islets you may use in future?
Dr. Bob Elliott says to (04:41):
we are not sure how often the transplants will need to be done, hopefully less than a year or two
Dr. Bob Elliott says to (04:41):
no side effects
Dr. Bob Elliott says to (04:42):
not yet (max number of islets)
Dr. Bob Elliott says to (04:43):
transplants should hopefully NOT be needed to be done in less than a year or two..
Jan3103 says to (04:43):
Maximum number of islets, if used, would mean patient does not have to use insulin? Though I would
settle for better and more stable blood sugars.
JoeC says to (04:43):
Hello Prof Elliott,
JoeC says to (04:43):
Any word from Mr. Cunliffe?
Dr. Bob Elliott says to (04:43):
Stable blood sugars have been a feature of the outcome so far. Even in those showing only a modest reduction in dose, an example, 18% dose reduction average blood glucose 6 with range of 5-7
Dr. Bob Elliott says to (04:44):
Hope to hear from Cunliffe within next few weeks
Jan3103 says to (04:44):
Transplants are working!
toddnsharla says to (04:44):
How exactly does it help with stabilizing blood sugars?
Dr. Bob Elliott says to (04:44):
yay!
Ellen1366 says to (04:45):
Just to make sure everyone understands, there is no immunosuppression or immune modulating drugs
with this procedure, correct?
Dr. Bob Elliott says to (04:45):
transplants respond to rise in blood glucose by producing some insulin, and turn off when blood glucose drops - just as normal islets work
Dr. Bob Elliott says to (04:45):
Definitely no immuno drugs
Monmon says to (04:45):
Do you use cells from the same pig? Autotransplant? and if yes ,is it gonna be the same on the trials with the patients?
Dr. Bob Elliott says to (04:46):
the colony used has been inbred over 200 years they are virtual twins. but multiple pigs used
Jan3103 says to (04:46):
Can the encapsulation used on the porcine islets be used on other islets from other sources, perhaps even islets created through stem cell research one day?
Sonia says to (04:46):
I was wondering if the porcine beta cells make some of the other hormones that we also see made by human beta cells?
toddnsharla says to (04:46):
Any difference in treating someone with, say brittle vs. relatively good control?
Dr. Bob Elliott says to (04:46):
We could use human islets, rabbit islets, islets from stem cells or cells genetically modified to make insulin
Dr. Bob Elliott says to (04:47):
Yes definitely make other hormones
Gina says to (04:47):
How do you conduct the trials without immunosuppresants?
Jan3103 says to (04:47):
Good point. Do the porcine islets also produce alpha and delta, producing glucagon and amylin?
Dr. Bob Elliott says to (04:47):
all the Russians have had excellent control, and I think results will be more startling if we had started with people with less control
Paula says to (04:47):
What are the 'negatives'? How long have they been observed?
Dr. Bob Elliott says to (04:48):
The capsule acts to make the islets invisible to the immune system - under the radar
toddnsharla says to (04:48):
Then I volunteer, cause I have less control :)
Sonia says to (04:48):
Dr. Elliot, how do we get the FDA to accept the results of the human trials? I think we have "DONE" the primate studies so thoroughly already!
Dr. Bob Elliott says to (04:48):
Yes
Dr. Bob Elliott says to (04:48):
Our first patient was in 1996; he is still making a tiny amount of porcine insulin
Hope says to (04:48):
What level of glucose the porcine cells react to?
Bob Hawkinson says to (04:48):
Hello Dr....I missed some of the earlier talk...about 15 years ago, I had heard they were having success with islet cell transplants along with bone marrow transplants so as not to have rejection. Are you aware if that is still having success?
toddnsharla says to (04:49):
Is he making those without new transplants?
JoeC says to (04:49):
How far is LCT from starting trials in the US? What are the major obstacles?
Dr. Bob Elliott says to (04:49):
Primates are a bad model, I hope the FDA regards humans with type 1 diabetes as being a better 'model'!
Monmon says to (04:49):
What about cord blood /stem cells?
Dr. Bob Elliott says to (04:49):
Not that I am aware of
Gina says to (04:49):
Everyone slow down a bit
Gina says to (04:49):
There are a lot of questions
Dr. Bob Elliott says to (04:50):
Cord blood /stem cells possible for some time in the future
Ellen1366 says to (04:50):
(Sorry Gina, we're so excited :))
Sonia says to (04:50):
I know that the FDA application in the U.S. will be very expensive. Is the best way to help to buy the LCT stock, and how can one go about doing that?
Gina says to (04:50):
I know me too
Dr. Bob Elliott says to (04:51):
LCT stock is available in the US under the OTCQX (pink pages)
Dr. Bob Elliott says to (04:51):
LCT has no income apart from good folk who invest in the company
toddnsharla says to (04:52):
so....you mention other neurological disorders on the website. What specifically have you looked at?
M.S.?
Hope says to Gina (04:52):
what level of blood glucose do the pig cells react to?
Sonia says to (04:52):
Sorry if I missed it, but are the results of the porcine C-peptide that was detected available yet? Are there other assays for other porcine hormones detected?
Dr. Bob Elliott says to (04:52):
Parkinson’s, Huntington’s, Alzheimer’s, stroke, auditory nerve degeneration
Dr. Bob Elliott says to (04:53):
The same as humans
Monmon says to (04:53):
Dr .Bob, are you communicating or following with other research centers like JDRF?
toddnsharla says to (04:53):
Nothing with multiple sclerosis
Gina says to (04:53):
What diabetes foundations are funding the research?
Dr. Bob Elliott says to (04:53):
We can’t measure porcine C-peptide in blood for technical reasons, so we measure porcine insulin itself
Dr. Bob Elliott says to (04:53):
Yes
Mel says to (04:53):
Have there been any problems with the seaweed gel coating so far Prof Elliott?
Jan3103 says to (04:54):
If there is insulin there has to be proinsulin?
Dr. Bob Elliott says to (04:54):
We had a symposium in Auckland recently to which the JDRF invited
Dr. Bob Elliott says to (04:54):
No problems with alginate
toddnsharla says to (04:54):
What is "porcine" exactly?
Dr. Bob Elliott says to (04:54):
Yes there is proinsulin
Dan says to (04:54):
Hi Dr. Elliott, Are the Russian patients counting carbs or can they eat more or less anything they want?
Dr. Bob Elliott says to (04:54):
Porcine = pig
Brensdad says to (04:54):
How young were your youngest in the trials?
Sonia says to (04:54):
The Children With Diabetes Foundation (CWDF) has been supporting Dr. Elliot's work for about a
decade - before the trials in Mexico I believe, and certainly before LCT was formalized. We are so proud to have helped. I consider it the best hope for my son
Dr. Bob Elliott says to (04:55):
Russian patients eat borscht dumplings and anything they like!
Dr. Bob Elliott says to (04:55):
in Russia = 23
Brensdad says to (04:55):
Any thoughts on if age would even matter?
Jan3103 says to (04:55):
No carb restrictions and still good post prandial blood sugars?
Dr. Bob Elliott says to (04:55):
Funding from Children with Diabetes only
Dr. Bob Elliott says to (04:56):
The younger the better, probably
Dr. Bob Elliott says to (04:56):
Yes
Dr. Bob Elliott says to (04:56):
(In normal range)
toddnsharla says to (04:56):
How do you go about figuring the amount of insulin to use? Is the ratio constantly changing based on
the amount of insulin produced?
Monmon says to (04:56):
I’m glad to be a member with CWD as well
Dr. Bob Elliott says to (04:56):
There is a very slow drop in insulin dose over the first three months and a very slow increase after that
Dr. Bob Elliott says to (04:57):
It’s just a matter of using the usual rules of increasing/decreasing insulin dose
toddnsharla says to (04:57):
Insulin pumps users as well?
Dr. Bob Elliott says to (04:57):
All of the Russian patients are on insulin pumps and continuous glucose monitoring
Hope says to (04:57):
I've read about new research to make the coating using nanotechnology, in order to be more predictable and performant. That may make the capsule reusable. Would you consider such
technologies in the future?
Brensdad says to (04:57):
Is CGM provided to make research more useful?
Dr. Bob Elliott says to (04:58):
We have a research division devoted entirely to looking at new encapsulation approaches
Dr. Bob Elliott says to (04:58):
Yes
Ellen1366 says to (04:58):
Will you need to bring the pigs to the US or will you process the islets in NZ and just bring the porcine islets here? Can you please tell us why your herd is particularly important for this therapy?
Dr. Bob Elliott says to (04:58):
Initially process the cells in nz, then take them to US. But establishing a herd in US will be necessary.
Brensdad says to (04:58):
In other words, will pigs fly?
Gina says to (04:59):
lol
Dr. Bob Elliott says to (04:59):
Our herd has been in natural quarantine for approx 200 years; they are much cleaner pigs than the norm
Gina says to (04:59):
Is there anyone here herding pigs for you yet?
Dr. Bob Elliott says to (04:59):
Yes!
toddnsharla says to (04:59):
Is participation in the study very intrusive on one's life? What is the typical involvement?
Dr. Bob Elliott says to (04:59):
Not yet but we have plans
Jan3103 says to (04:59):
Not WHEN pigs fly, pigs WILL fly, LOL.
Ravynne says to Gina (04:59):
Will people with Fibromyaligia be taken into consideration with this?
Gina says to (04:59):
I will herd them for you if you want JK
Dr. Bob Elliott says to (04:59):
The trial is very intrusive, but this is necessary for regulatory purposes
Sonia says to (05:00):
The quilt we made for the display in D.C. for Children With Diabetes has my son's face in the middle and it is surrounded by fabric, which features flying pigs!
Dr. Bob Elliott says to (05:00):
Yes (fibromyaligia)
toddnsharla says to (05:00):
Could you explain "intrusive?
Gina says to (05:00):
I saw that
Jan3103 says to (05:00):
I will volunteer for pig breeding. Bichon would love the little piglets.
Dr. Bob Elliott says to (05:00):
Constant monitoring, for life
Monmon says to (05:00):
How many years you need to judge about the transplantation results, I mean years of follow up and observation?
toddnsharla says to (05:00):
Don’t we already monitor for life?
Brensdad says to (05:01):
A lifetime of constant monitoring as in one BG check per day, week, month?
Dr. Bob Elliott says to (05:01):
First years results most important, but a lifetime is what we are looking at
Ravynne says to Gina (05:01):
I have several other health issues, would this prevent me from doing a trial?
Paula says to (05:01):
How old will people wanting to participate have to be?
toddnsharla says to (05:01):
I am already on a pump with cgm and testing 6 times a day on average...would that be any different?
Dr. Bob Elliott says to (05:02):
Monitoring will depend on whether the situations changing, obviously if you are off insulin, the
monitoring would only need to be done rarely
Brensdad says to (05:02):
Gosh, imagine feeling like a ticking time bomb!
Ellen1366 says to (05:02):
If you were a parent considering this for your child in human trials, what reservations would you have?
Dr. Bob Elliott says to (05:02):
Provided they are not life threatening conditions
toddnsharla says to (05:02):
Imagine not needing insulin!
Brensdad says to (05:02):
Imagine pigs flying...
Dr. Bob Elliott says to (05:02):
toddnsharla - no
Paula says to (05:02):
Depends at what cost Todd...imo
Ravynne says to (05:02):
I have several other health issues, would this prevent me from doing a trial
Mel says to (05:03):
LOL Brensdad
Dr. Bob Elliott says to (05:03):
No reservations - I would do it in my own children
Dr. Bob Elliott says to (05:03):
As long as they aren’t life threatening conditions
Brensdad says to (05:03):
Any ramifications or benefits for kids with other autoimmune problems such as JRA?
Jan3103 says to (05:03):
The one reservation would be if the encapsulation dissolves. Encapsulation is protection from animal virus, IF and I say IF there are retroviruses present. You would have to determine with certainty
procedure is safe.
Dr. Bob Elliott says to (05:03):
JRA would be acceptable, but not in the first instance
toddnsharla says to (05:04):
What is the actual risk of this Encapsulation issue?
Monmon says to (05:04):
So Dr. you will recommend the transplantation for everybody who needs Insulin or it will be case by case?
Gina says to (05:04):
Slow down
Dr. Bob Elliott says to (05:04):
I am not really concerned about the retrovirus; it has been given accidentally to people with a bleeding disorder intravenously on many occasions and has not caused any probs. Our cells do not produce the virus. We have a very extensive testing regime
Hope says to (05:05):
Do you think that the encapsulation is going to be commercial in Russia any time soon? If yes, would you recommend it to be done there before it becomes available elsewhere?
Sonia says to (05:05):
There are huge issues with transplantation of "embryonic" stem cells (uncontrolled growth- like cancer - for one), and of cadavaric cells (supply). Can you address why
Dr. Bob Elliott says to (05:06):
We are pushing for wide availability in Russia as soon as possible
Jan3103 says to (05:06):
Dr, Elliot, so you are saying this procedure is absolutely safe? That is good news.
Sonia says to (05:06):
Sorry - why supply won't be an issue and why the pigs are chosen at 4-7 days - so that growth from embryonic or age of cells is not an issue?
Dr. Bob Elliott says to (05:06):
Embryonic stem cells can convert to cancer cells, and are not stable. This is a technology for the future
Brensdad says to (05:06):
Will the Russians welcome (and be able to accommodate) hordes of people from other countries seeking the treatment?
Dr. Bob Elliott says to (05:06):
No procedure is ABSOLUTELY safe
Jan3103 says to (05:06):
I am excited but will let the adults be the guinea pigs, for now, LOL.
Paula says to (05:07):
Same thought here Jan3103
Ellen1366 says to (05:07):
With the current herd and breeding, how many humans are likely to be able to benefit in the next few years? How many pigs are necessary for one human to receive sufficient porcine islets?
Dr. Bob Elliott says to (05:07):
4-7 days was chosen mainly for yield of islets from pancreas, and reducing the possibility of exposure to infectious agents (from the animal attendants!!)
Hope says to (05:07):
You then do not see any danger from the escaped porcine cells or the residual capsule to generate cancer?
Dr. Bob Elliott says to (05:08):
About 1 transplant can be done with litters from one sow, per year. The limitation is the cost of the special facilities these animals need to be kept in. It costs about $20million for a 700 pig facility
Dr. Bob Elliott says to (05:08):
I can’t see any danger, the capsule is completely inert and alginate has been used surgically inside the abdomen for many decades
toddnsharla says to (05:09):
What is the largest risk to someone wanting to be involved?
Hope says to (05:09):
So do you think that the Russians have safe porcine supply?
Dr. Bob Elliott says to (05:09):
'Escaped’ porcine cells would be killed immediately by the immune system
Dr. Bob Elliott says to (05:09):
The waiting list!!
Dr. Bob Elliott says to (05:09):
The Russian cells come from nz
ydmv says to (05:09):
20 mil/700 = 28k per pig/yer
Jan3103 says to (05:09):
Why must the pigs be kept in the expensive facilities? Could you have certified breeders?
toddnsharla says to (05:09):
Should we contact Denver ASAP then?
Brensdad says to (05:09):
Where's the list!?!
Gina says to (05:10):
How do we get on the list!
Dr. Bob Elliott says to (05:10):
Sows will produce litters for about 7 years
Hope says to (05:10):
You mentioned before rabbits too. Wouldn't that be an more accessible source?
Dr. Bob Elliott says to (05:11):
Pigs can transmit disease, so it is essential that they be completely isolated from external environment, this includes air, water, feed, bedding, and even (as much as poss) the certified attendants
Brensdad says to (05:11):
Too much risk then to turnover to much anyone
Jan3103 says to (05:11):
Although I still have reservations about the "escaped" cells. Yes immune system will destroy immediately. But still patient would have been exposed to the porcine islet. Need human adult testing.
toddnsharla says to (05:11):
Especially Americans ;)
Monmon says to (05:12):
SO all cells which will be implanted to humans so far are only from Pigs?
Dr. Bob Elliott says to (05:12):
Rabbits are fine, but the yield from their pancreas is very small. You get the same yield from newborn rabbits but require several hundred. We know very little about rabbit diseases also
Heidi98 says to (05:12):
It’s a diabetes lottery
Dr. Bob Elliott says to (05:12):
Best not to eat a ham sandwich!!
toddnsharla says to (05:12):
So, how does one get on the list?
Brensdad says to (05:12):
Are there any animals that have a lot of "output?"
Gina says to (05:12):
Yea we want to get on the list
toddnsharla says to (05:12):
Would this be viable for a vegetarian ;)
Dr. Bob Elliott says to (05:13):
Contact BDC
Ellen1366 says to (05:13):
How many Russian human trial participants have there been so far? Do you think FDA will require placebo for a controlled study? I don't want placebo for my son.
Monmon says to (05:13):
What is BDC?
Brensdad says to (05:13):
Poor BDC, their phones will be busy in the morning!
Dr. Bob Elliott says to (05:13):
Vegetarians don’t EAT meat, nothing to say they cant have the transplant of animal cells
Brensdad says to (05:13):
Barbara Davis Center
Dr. Bob Elliott says to (05:13):
That’s the Jewish view
Monmon says to (05:13):
Thx
Gina says to (05:13):
IN DENVER RIGHT
Dr. Bob Elliott says to (05:13):
Yes Denver
Brensdad says to (05:14):
I worry if we could afford it?
Hope says to (05:14):
if you move to a "perfect" capsule, (nanatechnology), wouldn't these dangers go away? Is the virus smaller than the holes in the capsule, so it can get through anyway?
Dr. Bob Elliott says to (05:14):
The implants will be very expensive initially until pig facilities and cell processing facilities built
toddnsharla says to (05:15):
Good point, are there costs associated with the trial?
Dr. Bob Elliott says to (05:15):
The perfect nanocapsule is not available as yet.
Jan3103 says to (05:15):
Good point, Hope. Do the participants in the human trial studies have to pay for treatment? If BDC is
conducting treatment, won't that be free for the trial period?
Dr. Bob Elliott says to (05:15):
The trial will be expensive but that’s part of the development cost
Dr. Bob Elliott says to (05:15):
Which shareholders bear!
Brensdad says to (05:15):
What type of doctor or specialist does the implant? Is it limited to just a few?
Dr. Bob Elliott says to (05:16):
No, human trialists will not have to pay
Monmon says to (05:16):
Dr.Elliot, could you please tell us more about the implanted cells performance during Sick days? Or
induced stress in the animals on the trial currently?
Brensdad says to (05:16):
And if it works and becomes FDA approved ins. companies will line up to pay it I am sure.......?
Dr. Bob Elliott says to (05:16):
the procedure is extremely simple its the preparation of the pigs, th ecapsules and the cells that cost so
much
Hope says to (05:16):
My fear is that it will take years and years until available to all...
Dr. Bob Elliott says to (05:17):
Insurance companies SHOULD be interested as the cost per lifetime of type 1 diabetic is about $1Million
Jan3103 says to (05:17):
Brensdad, now THAT will be WHEN pigs fly, lol.
Dr. Bob Elliott says to (05:17):
No
Sonia says to (05:17):
The initial group of subjects at the BDC will all be adults. Please don't inundate them with calls as they will need a significant time in front of the FDA and there is significant fundraising that will be needed.
Gina says to (05:17):
Dr. B trust me insurance does not care
Gina says to (05:17):
We cant even get them to cover Continuous monitors
Gina says to (05:17):
Or insulin in some cases
Dr. Bob Elliott says to (05:17):
Many centres and probably many companies will have to be involved
Jon says (05:17):
What will the requirements be for selecting people for human trials?
Brensdad says to (05:18):
Are insurance companies being involved in this now, so the sticker shock doesn't scare them all off
when it is available?
Dr. Bob Elliott says to (05:18):
Initially, age, absence of other serious disease, willingness to cooperate with the arduous trial procedures etc
Ellen1366 says to (05:18):
Will it be helpful to have parents/people with diabetes/...testify before the NIH about the importance of approving human trials in the US? It seems NIH is starting to recognize porcine islet research
Bob Hawkinson says to (05:18):
Hopefully old guys.... D for a long time.... lol
Dr. Bob Elliott says to (05:18):
Not yet
Hope says to (05:19):
When are we going to hear again news from the Russian patients?
Dr. Bob Elliott says to (05:19):
Wouldn’t do any harm
Brensdad says to (05:19):
It would be a shame for all this work to be done, and it only be available to those who can afford it. Then everybody loses. Especially shareholders.
Dr. Bob Elliott says to (05:19):
Quarterly report due November
Dr. Bob Elliott says to (05:19):
The ones who can afford it initially, will be a source of funding for those less well off
Monmon says to (05:19):
Dr. I'm repeating my question, could you please give us a feedback about the implanted cells response and performance during unusual conditions? Like sick days, stress (e.g. induced stress in the animals on the trial currently) or Pregnancy?
Brensdad says to (05:19):
I can't imagine ins. not wanting to cover this though if it works out
Ellen1366 says to (05:19):
I remain so very optimistic
Jan3103 says to (05:20):
Dr. Elliot, when this does come to market, what are the projected costs for a porcine islet transplant?
Brensdad says to (05:20):
That's what Minimed probably thought about CGM technology too....
sstrumello says to (05:20):
Dr. Elliott, last week (August 20), the U.S. Food and Drug Administration had guidance on islet transplantation ... did LCT submit any comments on that??!
Dr. Bob Elliott says to (05:20):
We haven’t documented all of these, but the cells behave exactly the same way as normal human islets
Brensdad says to (05:20):
(Tp)
Dr. Bob Elliott says to (05:20):
No we didn’t
Hope says to (05:20):
Are you planning to open trials in other countries also? Canada, maybe?
Dr. Bob Elliott says to (05:21):
Russia, usa, new zealand only at the moment. But looking at others
Monmon says to (05:21):
This is very important to be documented as it may contradict or restrict it to be for all the ages or the
patients, maybe ..
Dr. Bob Elliott says to (05:22):
The age limitation is an FDA requirement at the moment
Jan3103 says to (05:22):
We can all buy stock, which, hopefully will appreciate, and help fund transplants at some future time for our loved ones. This is a way of supporting the company and your family. Win/win situation.
Hope says to (05:22):
The danger of viruses comes only if the capsule breaks, or even before that?
Ellen1366 says to (05:23):
You can designate a donation to LCT's DiabeCell http://www.cwdfoundation.org/
Monmon says to (05:23):
So if the cells are behaving really as normal one, it might help to answer FDA requirement at least from the age perspective
toddnsharla says to (05:23):
Isn’t FDA For Diabetics Always
Bonnie1797 says to (05:23):
Thank-you for your incredible research! It is very exciting!
Dr. Bob Elliott says to (05:24):
The only danger from breakage of the capsules is the theoretical one of the endogenous retrovirus. It shares the same antigens as the pig cells and this provokes an immediate destruction on contact with serum.
Dr. Bob Elliott says to (05:24):
Our pigs do not produce the retrovirus out side of the pig cells
Jan3103 says to (05:25):
Foolproof encapsulation that never breaks down would ease my mind considerably. And this may be done in future?
sstrumello says to (05:25):
Another requirement which made sense 15 years ago but is now questionable in light of more recent scientific evidence is the FDA guidance that patients should have "stimulated C-peptide should be <0.3 ng/mL". What are your thoughts on a cutoff like that?
Dr. Bob Elliott says to (05:26):
As you all know, the most important outcome is attaining stable blood glucose within the normal range, no hypos, highs, it would be nice if this could be done without any injected insulin at all
Dr. Bob Elliott says to (05:26):
But will be acceptable with a stable dose
Brensdad says to (05:26):
Will this be a basal injection like Lantus?
Dr. Bob Elliott says to (05:27):
Not sure yet but that’s the way its heading
Ellen1366 says to (05:27):
Yes, stable would be a quantum leap.
Ellen1366 says to (05:28):
Do you think there will be questions for decades about whether or not one should get pregnant after receiving these islets?
Dr. Bob Elliott says to (05:28):
Blood glucose all within the normal range 4-8 (x18)
Heidi98 says to (05:28):
Or some type 2's
Sonia says to (05:28):
My son has had T1DM, and is going off to college after 17 years with diabetes, and despite my best efforts, eats like a pig.... I think it is the perfect solutions! My sister used to be on porcine
insulin and still swears it was better than human!
Dr. Bob Elliott says to (05:29):
Dirty porcine insulin from the first few decades of treatment early last century would certainly have had porcine endogenous retrovirus in it
Brensdad says to (05:29):
Can this treatment be used in those with D antibodies but have not yet developed diabetes?
Dr. Bob Elliott says to (05:29):
We are thinking of transplantation as prevention
Jan3103 says to (05:29):
Okay, now you have eased my fears somewhat. That is correct!
Monmon says to (05:29):
So the patient will be using Insulin short-acting only with the meals? or still need Long acting with the implanted cells?
landileigh says to Gina (05:30):
Would this treatment work for someone like me who got diabetes via acute pancreatitis, someone who is an "Other" diabetic?
roque says to (05:30):
Fresh cell therapy, conducted on millions of patients all over the world since 1931, has demonstrated that injecting live cells without sterilization taken from animals raised with no special precautions into patients does not spread disease.
Dr. Bob Elliott says to (05:30):
I don’t know. The Russian patients are all on pumps. And have both basal and bolus
Gina says to (05:30):
Dr. Elliott, it has been an hour if you would like to stay to answer questions you can. Also would it be ok if people still had questions to send them to my email address and I will put them into the chat transcript?
Dr. Bob Elliott says to (05:30):
Yes you'd be easy
toddnsharla says to (05:30):
Is someone out of control a better candidate then someone in good control?
Dr. Bob Elliott says to (05:31):
Please send future questions to Gina, thanks all; it’s been informative for me
landileigh says to Gina (05:31):
Wow
Brensdad says to (05:31):
Thanks Dr. Bob
ydmv says to (05:31):
thanks Doc
Monmon says to (05:31):
Thanks Dr.Elliot
Gina says to (05:31):
if you send me your questions I will send them to Dr. Elliott
Ellen1366 says to (05:31):
Dr Elliott thank you for your continued dedication.
toddnsharla says to (05:31):
Thanks Dr. Bob and keep up the great work
Gina says to (05:31):
And put them into the transcript
Jan3103 says to (05:31):
Thank you so much. You are very generous with your time, Dr. Elliot.
Mel says to (05:31):
Thanks Dr Elliott :-)
Gina says to (05:31):
My email is gcapone1@optonline.net
Hope says to (05:31):
Thank you, Dr. Elliott.
karend1 says to (05:31):
thanks doc ;)
sstrumello says to (05:31):
Thanks Dr. Elliott ... you might consider publishing a newsletter!
Jon says (05:31):
Thank you for being her Dr. Elliott
Paula says to (05:31):
Thank you.
Ellen1366 says to (05:32):
Please let us know what we can do that would be helpful to move this along.
Bob Hawkinson says to (05:32):
Thanks for all the info doctor.... keep going ...we appreciate all you are doing...
Brensdad says to (05:32):
An email newsletter would help sell stock!!
sstrumello says to (05:32):
My thoughts exactly!
Brensdad says to (05:32):
Something we can put on our youtubes and fundraisers
Gina says to (05:32):
If your question didn’t get answered send it here my email is gcapone1@optonline.net
Monmon says to (05:33):
Thank you Gina
Sonia says to (05:33):
Thanks Professor Emeritus and my nomination for a nobel for your tenacity through all of these years. You are brilliant and we are lucky that we have you as an advocate!
Ellen1366 says to (05:33):
That was great Gina. Thank you for arranging this and it was great that so many showed up on a Sunday afternoon/Monday morning!:D
Jan3103 says to (05:33):
Gina, you have the most informative chats! I'm surprised you don't have hundreds of people loggin on!
Dr. Bob Elliott says to (04:23):
Well thank you
chelsea says to (04:24):
welcome dr bob
Gina says to (04:24):
Hi Dr. Elliott
Jon says (04:24):
Hi Dr. Elliott
Ellen1366 says to (04:25):
Good morning Dr. Elliott.
Gina says to (04:30):
Ok everyone
Gina says to (04:30):
we are going to get started
Gina says to (04:30):
remember
Gina says to (04:30):
to give Dr. Elliott a chance to answer your questions
Gina says to (04:31):
Start asking!
Dr. Bob Elliott says to (04:31):
It is a beautiful spring morning here in nz
Jon says (04:31):
Dr. Elliott, could you give us a brief description of what you are working on?
Dr. Bob Elliott says to (04:32):
Encapsulated piglet islets to treat (hopefully) cure diabetes
Ellen1366 says to (04:32):
Hi Dr. Elliott. Since it's so obvious there will never be enough human cadaver islets to restore
Euglycemia in people with diabetes, why do you think it's been so difficult to get approval for trials in NZ, Australia, US....?
Dr. Bob Elliott says to (04:32):
it is the animal source that is the problem
Dr. Bob Elliott says to (04:32):
pigs have bad press!
Paula says to (04:32):
why so
Heidi98 says to (04:33):
what sort of diseases could they pass on to humans
Dr. Bob Elliott says to (04:33):
fear of the unknown, and all of the theoretical stuff that came up about endogenous retrovirus
Hope says to (04:33):
Hello Dr. Elliott - could you please give us an idea as to when the human trials are going to start in US?
Dr. Bob Elliott says to (04:33):
106 diseases that pigs CAN pass on to humans, that we know of, but we make sure that our pigs don’t have these. PERV is a theoretical risk only
Dr. Bob Elliott says to (04:34):
first FDA application will be lodged before xmas
Dr. Bob Elliott says to (04:34):
Matters are out of our hands after that
Jan3103 says to (04:34):
Dr. Elliot, how secure is the encapsulation coating the islets? Could the coating wear off in ten or
twenty years, exposing the patient to the porcine islets?
Dr. Bob Elliott says to (04:34):
yes the coating could wear out, but the cells would then be destroyed together with any viruses they may contain
Monmon says to (04:35):
what about encapsulated immunosuppressive near to the implanted cells?
AllieB2 says to (04:35):
(people underestimate the power of the human immune system)
Dennis Leung HK says to (04:35):
Prof , will the US trial any big difference to that doing in Russia ?
Dr. Bob Elliott says to (04:36):
pig cells are destroyed immediately on contact with human serum together with any retrovirus
Dr. Bob Elliott says to (04:36):
US trial - dose will be bigger and there will be more people in the trial
Jan3103 says to (04:36):
However, once the coating wears off, the patient will be exposed to the islets, however briefly?
Dr. Bob Elliott says to (04:36):
yes
toddnsharla says to (04:36):
how can one get involved in the trial?
Dr. Bob Elliott says to (04:37):
The Barbara Davis Centre in Denver will be conducting the trial under the direction of Prof. Boris Draznin
landileigh says to (04:37):
I am an "Other", pancreas destroyed by Acute Pancreatitis due to duct obstruction. I have no c-peptide, would I be a candidate for islet transplantation?
Hope says to (04:37):
accumulated worn out capsules could be of any danger to the body?
Ellen1366 says to (04:37):
Would you be so kind as to update us on the trials going on in Russia right now, what you've learned so far, what you may want to change....?
Dr. Bob Elliott says to (04:38):
no, the amount of alginate is extremely small and is quite inert
Monmon says to (04:38):
Do we need to have an immunosuppressive near to the implanted cells capsule?
Gina says to (04:38):
slow down everyone
Jan3103 says to (04:38):
So the patient would be briefly exposed to any retroviruses present, after which islet and retrovirus (if any) would be destroyed?
Dr. Bob Elliott says to (04:39):
9 transplants done so far, without immunosuppression, three patients have had two transplants. so far, average dose reduction maximum has been about 50%
Dr. Bob Elliott says to (04:39):
and hemoglobin HbA1c reduced by 1.7% average
Bonnie1797 says to (04:39):
Hello Dr. Elliott, can you please share the process of transplants and how often one would need to have it done?
Jan3103 says to (04:40):
Great news!
Dr. Bob Elliott says to (04:40):
two patients have been going for a year, with dose reduction of 28% and 56% respectively
Gina says to (04:40):
that is great
Dr. Bob Elliott says to (04:40):
the cells are inserted via a laproscope into the abdominal cavity, currently under general anesthetic, this takes about 10mins
Ellen1366 says to (04:40):
What was the average baseline A1c prior?
Monmon says to (04:40):
do you mean insulin dose reduction?
Dr. Bob Elliott says to (04:41):
yes
Dr. Bob Elliott says to (04:41):
average
baseline was about 8%
Ellen1366 says to (04:41):
Any side effects?
Jan3103 says to (04:41):
And you are not using the maximum amount of islets you may use in future?
Dr. Bob Elliott says to (04:41):
we are not sure how often the transplants will need to be done, hopefully less than a year or two
Dr. Bob Elliott says to (04:41):
no side effects
Dr. Bob Elliott says to (04:42):
not yet (max number of islets)
Dr. Bob Elliott says to (04:43):
transplants should hopefully NOT be needed to be done in less than a year or two..
Jan3103 says to (04:43):
Maximum number of islets, if used, would mean patient does not have to use insulin? Though I would
settle for better and more stable blood sugars.
JoeC says to (04:43):
Hello Prof Elliott,
JoeC says to (04:43):
Any word from Mr. Cunliffe?
Dr. Bob Elliott says to (04:43):
Stable blood sugars have been a feature of the outcome so far. Even in those showing only a modest reduction in dose, an example, 18% dose reduction average blood glucose 6 with range of 5-7
Dr. Bob Elliott says to (04:44):
Hope to hear from Cunliffe within next few weeks
Jan3103 says to (04:44):
Transplants are working!
toddnsharla says to (04:44):
How exactly does it help with stabilizing blood sugars?
Dr. Bob Elliott says to (04:44):
yay!
Ellen1366 says to (04:45):
Just to make sure everyone understands, there is no immunosuppression or immune modulating drugs
with this procedure, correct?
Dr. Bob Elliott says to (04:45):
transplants respond to rise in blood glucose by producing some insulin, and turn off when blood glucose drops - just as normal islets work
Dr. Bob Elliott says to (04:45):
Definitely no immuno drugs
Monmon says to (04:45):
Do you use cells from the same pig? Autotransplant? and if yes ,is it gonna be the same on the trials with the patients?
Dr. Bob Elliott says to (04:46):
the colony used has been inbred over 200 years they are virtual twins. but multiple pigs used
Jan3103 says to (04:46):
Can the encapsulation used on the porcine islets be used on other islets from other sources, perhaps even islets created through stem cell research one day?
Sonia says to (04:46):
I was wondering if the porcine beta cells make some of the other hormones that we also see made by human beta cells?
toddnsharla says to (04:46):
Any difference in treating someone with, say brittle vs. relatively good control?
Dr. Bob Elliott says to (04:46):
We could use human islets, rabbit islets, islets from stem cells or cells genetically modified to make insulin
Dr. Bob Elliott says to (04:47):
Yes definitely make other hormones
Gina says to (04:47):
How do you conduct the trials without immunosuppresants?
Jan3103 says to (04:47):
Good point. Do the porcine islets also produce alpha and delta, producing glucagon and amylin?
Dr. Bob Elliott says to (04:47):
all the Russians have had excellent control, and I think results will be more startling if we had started with people with less control
Paula says to (04:47):
What are the 'negatives'? How long have they been observed?
Dr. Bob Elliott says to (04:48):
The capsule acts to make the islets invisible to the immune system - under the radar
toddnsharla says to (04:48):
Then I volunteer, cause I have less control :)
Sonia says to (04:48):
Dr. Elliot, how do we get the FDA to accept the results of the human trials? I think we have "DONE" the primate studies so thoroughly already!
Dr. Bob Elliott says to (04:48):
Yes
Dr. Bob Elliott says to (04:48):
Our first patient was in 1996; he is still making a tiny amount of porcine insulin
Hope says to (04:48):
What level of glucose the porcine cells react to?
Bob Hawkinson says to (04:48):
Hello Dr....I missed some of the earlier talk...about 15 years ago, I had heard they were having success with islet cell transplants along with bone marrow transplants so as not to have rejection. Are you aware if that is still having success?
toddnsharla says to (04:49):
Is he making those without new transplants?
JoeC says to (04:49):
How far is LCT from starting trials in the US? What are the major obstacles?
Dr. Bob Elliott says to (04:49):
Primates are a bad model, I hope the FDA regards humans with type 1 diabetes as being a better 'model'!
Monmon says to (04:49):
What about cord blood /stem cells?
Dr. Bob Elliott says to (04:49):
Not that I am aware of
Gina says to (04:49):
Everyone slow down a bit
Gina says to (04:49):
There are a lot of questions
Dr. Bob Elliott says to (04:50):
Cord blood /stem cells possible for some time in the future
Ellen1366 says to (04:50):
(Sorry Gina, we're so excited :))
Sonia says to (04:50):
I know that the FDA application in the U.S. will be very expensive. Is the best way to help to buy the LCT stock, and how can one go about doing that?
Gina says to (04:50):
I know me too
Dr. Bob Elliott says to (04:51):
LCT stock is available in the US under the OTCQX (pink pages)
Dr. Bob Elliott says to (04:51):
LCT has no income apart from good folk who invest in the company
toddnsharla says to (04:52):
so....you mention other neurological disorders on the website. What specifically have you looked at?
M.S.?
Hope says to Gina (04:52):
what level of blood glucose do the pig cells react to?
Sonia says to (04:52):
Sorry if I missed it, but are the results of the porcine C-peptide that was detected available yet? Are there other assays for other porcine hormones detected?
Dr. Bob Elliott says to (04:52):
Parkinson’s, Huntington’s, Alzheimer’s, stroke, auditory nerve degeneration
Dr. Bob Elliott says to (04:53):
The same as humans
Monmon says to (04:53):
Dr .Bob, are you communicating or following with other research centers like JDRF?
toddnsharla says to (04:53):
Nothing with multiple sclerosis
Gina says to (04:53):
What diabetes foundations are funding the research?
Dr. Bob Elliott says to (04:53):
We can’t measure porcine C-peptide in blood for technical reasons, so we measure porcine insulin itself
Dr. Bob Elliott says to (04:53):
Yes
Mel says to (04:53):
Have there been any problems with the seaweed gel coating so far Prof Elliott?
Jan3103 says to (04:54):
If there is insulin there has to be proinsulin?
Dr. Bob Elliott says to (04:54):
We had a symposium in Auckland recently to which the JDRF invited
Dr. Bob Elliott says to (04:54):
No problems with alginate
toddnsharla says to (04:54):
What is "porcine" exactly?
Dr. Bob Elliott says to (04:54):
Yes there is proinsulin
Dan says to (04:54):
Hi Dr. Elliott, Are the Russian patients counting carbs or can they eat more or less anything they want?
Dr. Bob Elliott says to (04:54):
Porcine = pig
Brensdad says to (04:54):
How young were your youngest in the trials?
Sonia says to (04:54):
The Children With Diabetes Foundation (CWDF) has been supporting Dr. Elliot's work for about a
decade - before the trials in Mexico I believe, and certainly before LCT was formalized. We are so proud to have helped. I consider it the best hope for my son
Dr. Bob Elliott says to (04:55):
Russian patients eat borscht dumplings and anything they like!
Dr. Bob Elliott says to (04:55):
in Russia = 23
Brensdad says to (04:55):
Any thoughts on if age would even matter?
Jan3103 says to (04:55):
No carb restrictions and still good post prandial blood sugars?
Dr. Bob Elliott says to (04:55):
Funding from Children with Diabetes only
Dr. Bob Elliott says to (04:56):
The younger the better, probably
Dr. Bob Elliott says to (04:56):
Yes
Dr. Bob Elliott says to (04:56):
(In normal range)
toddnsharla says to (04:56):
How do you go about figuring the amount of insulin to use? Is the ratio constantly changing based on
the amount of insulin produced?
Monmon says to (04:56):
I’m glad to be a member with CWD as well
Dr. Bob Elliott says to (04:56):
There is a very slow drop in insulin dose over the first three months and a very slow increase after that
Dr. Bob Elliott says to (04:57):
It’s just a matter of using the usual rules of increasing/decreasing insulin dose
toddnsharla says to (04:57):
Insulin pumps users as well?
Dr. Bob Elliott says to (04:57):
All of the Russian patients are on insulin pumps and continuous glucose monitoring
Hope says to (04:57):
I've read about new research to make the coating using nanotechnology, in order to be more predictable and performant. That may make the capsule reusable. Would you consider such
technologies in the future?
Brensdad says to (04:57):
Is CGM provided to make research more useful?
Dr. Bob Elliott says to (04:58):
We have a research division devoted entirely to looking at new encapsulation approaches
Dr. Bob Elliott says to (04:58):
Yes
Ellen1366 says to (04:58):
Will you need to bring the pigs to the US or will you process the islets in NZ and just bring the porcine islets here? Can you please tell us why your herd is particularly important for this therapy?
Dr. Bob Elliott says to (04:58):
Initially process the cells in nz, then take them to US. But establishing a herd in US will be necessary.
Brensdad says to (04:58):
In other words, will pigs fly?
Gina says to (04:59):
lol
Dr. Bob Elliott says to (04:59):
Our herd has been in natural quarantine for approx 200 years; they are much cleaner pigs than the norm
Gina says to (04:59):
Is there anyone here herding pigs for you yet?
Dr. Bob Elliott says to (04:59):
Yes!
toddnsharla says to (04:59):
Is participation in the study very intrusive on one's life? What is the typical involvement?
Dr. Bob Elliott says to (04:59):
Not yet but we have plans
Jan3103 says to (04:59):
Not WHEN pigs fly, pigs WILL fly, LOL.
Ravynne says to Gina (04:59):
Will people with Fibromyaligia be taken into consideration with this?
Gina says to (04:59):
I will herd them for you if you want JK
Dr. Bob Elliott says to (04:59):
The trial is very intrusive, but this is necessary for regulatory purposes
Sonia says to (05:00):
The quilt we made for the display in D.C. for Children With Diabetes has my son's face in the middle and it is surrounded by fabric, which features flying pigs!
Dr. Bob Elliott says to (05:00):
Yes (fibromyaligia)
toddnsharla says to (05:00):
Could you explain "intrusive?
Gina says to (05:00):
I saw that
Jan3103 says to (05:00):
I will volunteer for pig breeding. Bichon would love the little piglets.
Dr. Bob Elliott says to (05:00):
Constant monitoring, for life
Monmon says to (05:00):
How many years you need to judge about the transplantation results, I mean years of follow up and observation?
toddnsharla says to (05:00):
Don’t we already monitor for life?
Brensdad says to (05:01):
A lifetime of constant monitoring as in one BG check per day, week, month?
Dr. Bob Elliott says to (05:01):
First years results most important, but a lifetime is what we are looking at
Ravynne says to Gina (05:01):
I have several other health issues, would this prevent me from doing a trial?
Paula says to (05:01):
How old will people wanting to participate have to be?
toddnsharla says to (05:01):
I am already on a pump with cgm and testing 6 times a day on average...would that be any different?
Dr. Bob Elliott says to (05:02):
Monitoring will depend on whether the situations changing, obviously if you are off insulin, the
monitoring would only need to be done rarely
Brensdad says to (05:02):
Gosh, imagine feeling like a ticking time bomb!
Ellen1366 says to (05:02):
If you were a parent considering this for your child in human trials, what reservations would you have?
Dr. Bob Elliott says to (05:02):
Provided they are not life threatening conditions
toddnsharla says to (05:02):
Imagine not needing insulin!
Brensdad says to (05:02):
Imagine pigs flying...
Dr. Bob Elliott says to (05:02):
toddnsharla - no
Paula says to (05:02):
Depends at what cost Todd...imo
Ravynne says to (05:02):
I have several other health issues, would this prevent me from doing a trial
Mel says to (05:03):
LOL Brensdad
Dr. Bob Elliott says to (05:03):
No reservations - I would do it in my own children
Dr. Bob Elliott says to (05:03):
As long as they aren’t life threatening conditions
Brensdad says to (05:03):
Any ramifications or benefits for kids with other autoimmune problems such as JRA?
Jan3103 says to (05:03):
The one reservation would be if the encapsulation dissolves. Encapsulation is protection from animal virus, IF and I say IF there are retroviruses present. You would have to determine with certainty
procedure is safe.
Dr. Bob Elliott says to (05:03):
JRA would be acceptable, but not in the first instance
toddnsharla says to (05:04):
What is the actual risk of this Encapsulation issue?
Monmon says to (05:04):
So Dr. you will recommend the transplantation for everybody who needs Insulin or it will be case by case?
Gina says to (05:04):
Slow down
Dr. Bob Elliott says to (05:04):
I am not really concerned about the retrovirus; it has been given accidentally to people with a bleeding disorder intravenously on many occasions and has not caused any probs. Our cells do not produce the virus. We have a very extensive testing regime
Hope says to (05:05):
Do you think that the encapsulation is going to be commercial in Russia any time soon? If yes, would you recommend it to be done there before it becomes available elsewhere?
Sonia says to (05:05):
There are huge issues with transplantation of "embryonic" stem cells (uncontrolled growth- like cancer - for one), and of cadavaric cells (supply). Can you address why
Dr. Bob Elliott says to (05:06):
We are pushing for wide availability in Russia as soon as possible
Jan3103 says to (05:06):
Dr, Elliot, so you are saying this procedure is absolutely safe? That is good news.
Sonia says to (05:06):
Sorry - why supply won't be an issue and why the pigs are chosen at 4-7 days - so that growth from embryonic or age of cells is not an issue?
Dr. Bob Elliott says to (05:06):
Embryonic stem cells can convert to cancer cells, and are not stable. This is a technology for the future
Brensdad says to (05:06):
Will the Russians welcome (and be able to accommodate) hordes of people from other countries seeking the treatment?
Dr. Bob Elliott says to (05:06):
No procedure is ABSOLUTELY safe
Jan3103 says to (05:06):
I am excited but will let the adults be the guinea pigs, for now, LOL.
Paula says to (05:07):
Same thought here Jan3103
Ellen1366 says to (05:07):
With the current herd and breeding, how many humans are likely to be able to benefit in the next few years? How many pigs are necessary for one human to receive sufficient porcine islets?
Dr. Bob Elliott says to (05:07):
4-7 days was chosen mainly for yield of islets from pancreas, and reducing the possibility of exposure to infectious agents (from the animal attendants!!)
Hope says to (05:07):
You then do not see any danger from the escaped porcine cells or the residual capsule to generate cancer?
Dr. Bob Elliott says to (05:08):
About 1 transplant can be done with litters from one sow, per year. The limitation is the cost of the special facilities these animals need to be kept in. It costs about $20million for a 700 pig facility
Dr. Bob Elliott says to (05:08):
I can’t see any danger, the capsule is completely inert and alginate has been used surgically inside the abdomen for many decades
toddnsharla says to (05:09):
What is the largest risk to someone wanting to be involved?
Hope says to (05:09):
So do you think that the Russians have safe porcine supply?
Dr. Bob Elliott says to (05:09):
'Escaped’ porcine cells would be killed immediately by the immune system
Dr. Bob Elliott says to (05:09):
The waiting list!!
Dr. Bob Elliott says to (05:09):
The Russian cells come from nz
ydmv says to (05:09):
20 mil/700 = 28k per pig/yer
Jan3103 says to (05:09):
Why must the pigs be kept in the expensive facilities? Could you have certified breeders?
toddnsharla says to (05:09):
Should we contact Denver ASAP then?
Brensdad says to (05:09):
Where's the list!?!
Gina says to (05:10):
How do we get on the list!
Dr. Bob Elliott says to (05:10):
Sows will produce litters for about 7 years
Hope says to (05:10):
You mentioned before rabbits too. Wouldn't that be an more accessible source?
Dr. Bob Elliott says to (05:11):
Pigs can transmit disease, so it is essential that they be completely isolated from external environment, this includes air, water, feed, bedding, and even (as much as poss) the certified attendants
Brensdad says to (05:11):
Too much risk then to turnover to much anyone
Jan3103 says to (05:11):
Although I still have reservations about the "escaped" cells. Yes immune system will destroy immediately. But still patient would have been exposed to the porcine islet. Need human adult testing.
toddnsharla says to (05:11):
Especially Americans ;)
Monmon says to (05:12):
SO all cells which will be implanted to humans so far are only from Pigs?
Dr. Bob Elliott says to (05:12):
Rabbits are fine, but the yield from their pancreas is very small. You get the same yield from newborn rabbits but require several hundred. We know very little about rabbit diseases also
Heidi98 says to (05:12):
It’s a diabetes lottery
Dr. Bob Elliott says to (05:12):
Best not to eat a ham sandwich!!
toddnsharla says to (05:12):
So, how does one get on the list?
Brensdad says to (05:12):
Are there any animals that have a lot of "output?"
Gina says to (05:12):
Yea we want to get on the list
toddnsharla says to (05:12):
Would this be viable for a vegetarian ;)
Dr. Bob Elliott says to (05:13):
Contact BDC
Ellen1366 says to (05:13):
How many Russian human trial participants have there been so far? Do you think FDA will require placebo for a controlled study? I don't want placebo for my son.
Monmon says to (05:13):
What is BDC?
Brensdad says to (05:13):
Poor BDC, their phones will be busy in the morning!
Dr. Bob Elliott says to (05:13):
Vegetarians don’t EAT meat, nothing to say they cant have the transplant of animal cells
Brensdad says to (05:13):
Barbara Davis Center
Dr. Bob Elliott says to (05:13):
That’s the Jewish view
Monmon says to (05:13):
Thx
Gina says to (05:13):
IN DENVER RIGHT
Dr. Bob Elliott says to (05:13):
Yes Denver
Brensdad says to (05:14):
I worry if we could afford it?
Hope says to (05:14):
if you move to a "perfect" capsule, (nanatechnology), wouldn't these dangers go away? Is the virus smaller than the holes in the capsule, so it can get through anyway?
Dr. Bob Elliott says to (05:14):
The implants will be very expensive initially until pig facilities and cell processing facilities built
toddnsharla says to (05:15):
Good point, are there costs associated with the trial?
Dr. Bob Elliott says to (05:15):
The perfect nanocapsule is not available as yet.
Jan3103 says to (05:15):
Good point, Hope. Do the participants in the human trial studies have to pay for treatment? If BDC is
conducting treatment, won't that be free for the trial period?
Dr. Bob Elliott says to (05:15):
The trial will be expensive but that’s part of the development cost
Dr. Bob Elliott says to (05:15):
Which shareholders bear!
Brensdad says to (05:15):
What type of doctor or specialist does the implant? Is it limited to just a few?
Dr. Bob Elliott says to (05:16):
No, human trialists will not have to pay
Monmon says to (05:16):
Dr.Elliot, could you please tell us more about the implanted cells performance during Sick days? Or
induced stress in the animals on the trial currently?
Brensdad says to (05:16):
And if it works and becomes FDA approved ins. companies will line up to pay it I am sure.......?
Dr. Bob Elliott says to (05:16):
the procedure is extremely simple its the preparation of the pigs, th ecapsules and the cells that cost so
much
Hope says to (05:16):
My fear is that it will take years and years until available to all...
Dr. Bob Elliott says to (05:17):
Insurance companies SHOULD be interested as the cost per lifetime of type 1 diabetic is about $1Million
Jan3103 says to (05:17):
Brensdad, now THAT will be WHEN pigs fly, lol.
Dr. Bob Elliott says to (05:17):
No
Sonia says to (05:17):
The initial group of subjects at the BDC will all be adults. Please don't inundate them with calls as they will need a significant time in front of the FDA and there is significant fundraising that will be needed.
Gina says to (05:17):
Dr. B trust me insurance does not care
Gina says to (05:17):
We cant even get them to cover Continuous monitors
Gina says to (05:17):
Or insulin in some cases
Dr. Bob Elliott says to (05:17):
Many centres and probably many companies will have to be involved
Jon says (05:17):
What will the requirements be for selecting people for human trials?
Brensdad says to (05:18):
Are insurance companies being involved in this now, so the sticker shock doesn't scare them all off
when it is available?
Dr. Bob Elliott says to (05:18):
Initially, age, absence of other serious disease, willingness to cooperate with the arduous trial procedures etc
Ellen1366 says to (05:18):
Will it be helpful to have parents/people with diabetes/...testify before the NIH about the importance of approving human trials in the US? It seems NIH is starting to recognize porcine islet research
Bob Hawkinson says to (05:18):
Hopefully old guys.... D for a long time.... lol
Dr. Bob Elliott says to (05:18):
Not yet
Hope says to (05:19):
When are we going to hear again news from the Russian patients?
Dr. Bob Elliott says to (05:19):
Wouldn’t do any harm
Brensdad says to (05:19):
It would be a shame for all this work to be done, and it only be available to those who can afford it. Then everybody loses. Especially shareholders.
Dr. Bob Elliott says to (05:19):
Quarterly report due November
Dr. Bob Elliott says to (05:19):
The ones who can afford it initially, will be a source of funding for those less well off
Monmon says to (05:19):
Dr. I'm repeating my question, could you please give us a feedback about the implanted cells response and performance during unusual conditions? Like sick days, stress (e.g. induced stress in the animals on the trial currently) or Pregnancy?
Brensdad says to (05:19):
I can't imagine ins. not wanting to cover this though if it works out
Ellen1366 says to (05:19):
I remain so very optimistic
Jan3103 says to (05:20):
Dr. Elliot, when this does come to market, what are the projected costs for a porcine islet transplant?
Brensdad says to (05:20):
That's what Minimed probably thought about CGM technology too....
sstrumello says to (05:20):
Dr. Elliott, last week (August 20), the U.S. Food and Drug Administration had guidance on islet transplantation ... did LCT submit any comments on that??!
Dr. Bob Elliott says to (05:20):
We haven’t documented all of these, but the cells behave exactly the same way as normal human islets
Brensdad says to (05:20):
(Tp)
Dr. Bob Elliott says to (05:20):
No we didn’t
Hope says to (05:20):
Are you planning to open trials in other countries also? Canada, maybe?
Dr. Bob Elliott says to (05:21):
Russia, usa, new zealand only at the moment. But looking at others
Monmon says to (05:21):
This is very important to be documented as it may contradict or restrict it to be for all the ages or the
patients, maybe ..
Dr. Bob Elliott says to (05:22):
The age limitation is an FDA requirement at the moment
Jan3103 says to (05:22):
We can all buy stock, which, hopefully will appreciate, and help fund transplants at some future time for our loved ones. This is a way of supporting the company and your family. Win/win situation.
Hope says to (05:22):
The danger of viruses comes only if the capsule breaks, or even before that?
Ellen1366 says to (05:23):
You can designate a donation to LCT's DiabeCell http://www.cwdfoundation.org/
Monmon says to (05:23):
So if the cells are behaving really as normal one, it might help to answer FDA requirement at least from the age perspective
toddnsharla says to (05:23):
Isn’t FDA For Diabetics Always
Bonnie1797 says to (05:23):
Thank-you for your incredible research! It is very exciting!
Dr. Bob Elliott says to (05:24):
The only danger from breakage of the capsules is the theoretical one of the endogenous retrovirus. It shares the same antigens as the pig cells and this provokes an immediate destruction on contact with serum.
Dr. Bob Elliott says to (05:24):
Our pigs do not produce the retrovirus out side of the pig cells
Jan3103 says to (05:25):
Foolproof encapsulation that never breaks down would ease my mind considerably. And this may be done in future?
sstrumello says to (05:25):
Another requirement which made sense 15 years ago but is now questionable in light of more recent scientific evidence is the FDA guidance that patients should have "stimulated C-peptide should be <0.3 ng/mL". What are your thoughts on a cutoff like that?
Dr. Bob Elliott says to (05:26):
As you all know, the most important outcome is attaining stable blood glucose within the normal range, no hypos, highs, it would be nice if this could be done without any injected insulin at all
Dr. Bob Elliott says to (05:26):
But will be acceptable with a stable dose
Brensdad says to (05:26):
Will this be a basal injection like Lantus?
Dr. Bob Elliott says to (05:27):
Not sure yet but that’s the way its heading
Ellen1366 says to (05:27):
Yes, stable would be a quantum leap.
Ellen1366 says to (05:28):
Do you think there will be questions for decades about whether or not one should get pregnant after receiving these islets?
Dr. Bob Elliott says to (05:28):
Blood glucose all within the normal range 4-8 (x18)
Heidi98 says to (05:28):
Or some type 2's
Sonia says to (05:28):
My son has had T1DM, and is going off to college after 17 years with diabetes, and despite my best efforts, eats like a pig.... I think it is the perfect solutions! My sister used to be on porcine
insulin and still swears it was better than human!
Dr. Bob Elliott says to (05:29):
Dirty porcine insulin from the first few decades of treatment early last century would certainly have had porcine endogenous retrovirus in it
Brensdad says to (05:29):
Can this treatment be used in those with D antibodies but have not yet developed diabetes?
Dr. Bob Elliott says to (05:29):
We are thinking of transplantation as prevention
Jan3103 says to (05:29):
Okay, now you have eased my fears somewhat. That is correct!
Monmon says to (05:29):
So the patient will be using Insulin short-acting only with the meals? or still need Long acting with the implanted cells?
landileigh says to Gina (05:30):
Would this treatment work for someone like me who got diabetes via acute pancreatitis, someone who is an "Other" diabetic?
roque says to (05:30):
Fresh cell therapy, conducted on millions of patients all over the world since 1931, has demonstrated that injecting live cells without sterilization taken from animals raised with no special precautions into patients does not spread disease.
Dr. Bob Elliott says to (05:30):
I don’t know. The Russian patients are all on pumps. And have both basal and bolus
Gina says to (05:30):
Dr. Elliott, it has been an hour if you would like to stay to answer questions you can. Also would it be ok if people still had questions to send them to my email address and I will put them into the chat transcript?
Dr. Bob Elliott says to (05:30):
Yes you'd be easy
toddnsharla says to (05:30):
Is someone out of control a better candidate then someone in good control?
Dr. Bob Elliott says to (05:31):
Please send future questions to Gina, thanks all; it’s been informative for me
landileigh says to Gina (05:31):
Wow
Brensdad says to (05:31):
Thanks Dr. Bob
ydmv says to (05:31):
thanks Doc
Monmon says to (05:31):
Thanks Dr.Elliot
Gina says to (05:31):
if you send me your questions I will send them to Dr. Elliott
Ellen1366 says to (05:31):
Dr Elliott thank you for your continued dedication.
toddnsharla says to (05:31):
Thanks Dr. Bob and keep up the great work
Gina says to (05:31):
And put them into the transcript
Jan3103 says to (05:31):
Thank you so much. You are very generous with your time, Dr. Elliot.
Mel says to (05:31):
Thanks Dr Elliott :-)
Gina says to (05:31):
My email is gcapone1@optonline.net
Hope says to (05:31):
Thank you, Dr. Elliott.
karend1 says to (05:31):
thanks doc ;)
sstrumello says to (05:31):
Thanks Dr. Elliott ... you might consider publishing a newsletter!
Jon says (05:31):
Thank you for being her Dr. Elliott
Paula says to (05:31):
Thank you.
Ellen1366 says to (05:32):
Please let us know what we can do that would be helpful to move this along.
Bob Hawkinson says to (05:32):
Thanks for all the info doctor.... keep going ...we appreciate all you are doing...
Brensdad says to (05:32):
An email newsletter would help sell stock!!
sstrumello says to (05:32):
My thoughts exactly!
Brensdad says to (05:32):
Something we can put on our youtubes and fundraisers
Gina says to (05:32):
If your question didn’t get answered send it here my email is gcapone1@optonline.net
Monmon says to (05:33):
Thank you Gina
Sonia says to (05:33):
Thanks Professor Emeritus and my nomination for a nobel for your tenacity through all of these years. You are brilliant and we are lucky that we have you as an advocate!
Ellen1366 says to (05:33):
That was great Gina. Thank you for arranging this and it was great that so many showed up on a Sunday afternoon/Monday morning!:D
Jan3103 says to (05:33):
Gina, you have the most informative chats! I'm surprised you don't have hundreds of people loggin on!
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