Uuuuuuh. Thanks for that. It’s a dose of reality.
1 Like
I have heard speculation that the emergence of covid variants may have been related to immunosuppresants. I don’t think this is an established fact, just a possibility. I would also hasten to add that having been vaccinated before going on the immunosuppresants may mitigate or even eliminate that disturbing possibility.
My apologies if this is alarmist or outdated information. I’m happy to be corrected by anyone who knows better.
Here is the flier they sent to me.
It says everyone gets the immunosuppressants but on the phone they said only half and half gets placebo.
I still have lots of questions. I’ll speak to coordinator soon.
If anyone can think of other questions to ask I will appreciate it.
1 location of implants.
2 all about immunosuppressants and who gets them.
3 why immunosuppressants suppressants in a encapsulated device.
4 will it be enough to allow me to stop insulin
5 will I get to keep them after study if they are still functional
I think the capsule for PEC-Direct does not protect the cells inside from the immune systems
The PEC-Encap capsule protects the cells.
I could be missing something, but it looks like the trial flier you received only references PEC-Direct so immunosuppressants would be required.
Here’s a chart from Viacyte’s website about their products in development.
1 Like
+1. My understanding is if it is the DIRECT model then everyone is on suppressants. So you’d want to clear that up too.
There are 3 studies happening. And well probs everyone wants the final one.
I know about this, and even invested in the company who did the science. Seems very exciting. You have to decide for yourself, but if given the opportunity, I would do it.
I had 3 beta cell transplants into the portal vein in 2002 +2003. I have been on 2 immunosuppressants since then. That’s 19 years this month! I was completely off insulin for 3 years.
That may seem like a short timeframe, but I am so glad I volunteered. I am still here and still producing some insulin, but not enough to not need exogenous insulin.
It does take work to calculate basal and bolus insulin , but I have many challenges in the 62 years I have had T1D and this is a challenge I am happy to face.
Before transplants I required over 60 units a day, and now I take 20 units. As the cells weaken, I have increased a little each year since transplants. But for the most part I believe the transplants have added years to my life.
The other reason I am glad I did it is because
I know I have helped so many children with diabetes perhaps have long lives because of the advances being made like the encapsulated study you are considering.
You take chances in any study. Some people have lots of problems and other have only a few. Wishing you good health whatever you decide.
5 Likes
I did a trial with Viactye about 4 years ago. It was a safety and procedure trial. I think they did 11 people. It was also a 2 years trial but was ended early due to the cells not making it.
I went through 5 surgeries putting them in and taking the different devices out. And I was put on a low dose of autoimmune suppression drugs and was off them within about a month, but it didn’t help as all the cells died.
They had to go back to finding a holder of the cells that the body would allow the blood to flow through to keep the cells alive but not allow our antibodies through that would destroy the cells. (This will be a huge challenge!)
They moved forward with the trial that put people on suppression drugs and I was just not in on that one.
And yes, when in a trial, you don’t know what group you will end up in. It is a major bummer it you end up in the group that ends up being the control group.
With any trial, you need to decided how important this is to you and what the risks are. I was not happy about 5 surgeries but there was literally 6 or 7 doctors in the surgical suite for the first one. And the check ins were weekly in the beginning. They watch you like a hawk and the paperwork was intense. But if they were offering cells that would actually produce insulin, I might do it again. But mine was just safety issues so I didn’t get enough cells to make insulin. But wow, I so want this to work, so I say, yeah I’m in as long as I get in on another trial I wanted. iLet pump trial, more about that one later.
So I did it. I used drugs for a month. I had a lot of surgeries. I had some wicked tough tests during the procedure. But I figure I can’t whine about no cure, if I don’t help when I can to move it along.
So, talk with the doctors about risks to you and your life style. And if there would be some benefits for you or is it just trial info they are looking for. Good luck!
4 Likes
Re:research and risk. I worked for a small research program years ago—mainly topical products, but also some early stage oral diabetes drugs—and risks, even the most awful and remote, were clearly spelled out in permission/participation forms. No participant went in blind, every known possibility was included. The value of the research with thousands of real people is learning the things that can’t be foreseen, good and bad.
I’m hopeful that this research is effective. Maybe one day we can all take a once a month shot of beta cells, like once a month estrogen (or once a week Trulicity!) and live happily ever after!
1 Like
Ok I have researched this and I spoke to the study nurse and doc. I think I’m moving forward, but I haven’t made the final decision yet.
The completely encapsulated transplant failed so that’s why this study that is partially encapsulated will be implemented.
It has small holes that will allow capillaries to move into the implants.
This also means a low dose anti rejection drug, which I’m reading about.
Out of all the transplant options, I think this is the best one.
I’m still on the fence. Only people under 65 are eligible so that’s only 10 years for me.
I need to either do this or forget about it.
I’m still on the fence but I’m optimistically moving forward
When I did the first Viactye study, I was given a low level of anti rejection drugs for about a month. Blood sugars were a little higher but I figured it was just for a short period of time & the doctors were super about helping get a handle on them. And yes, the devices just didn’t let the blood vessels to migrate in, so they all died. I am hoping this works! This is where I think the cure will come from, just so much to work out. Good luck if you decide to go for it.
1 Like