Straight Dope on Medicine: Type I Diabetes No More

Who wants Type I Diabetes?

I would presume no one.

That’s a good thing because our scientific cadre is working hard to make it a relic.

Celltrans, out of Chicago has scored a direct hit in the ongoing war against disease.[i]

Thursday, the FDA signed off on CellTrans’ Lantidra (donislecel), the first cell therapy for Type 1 diabetes. The treatment, mined from deceased donor pancreatic cells, is for patients who are unable to achieve average blood glucose levels with daily insulin injections or with continuous infusion by way of a pump.

“Severe hypoglycemia is a dangerous condition that can lead to injuries resulting from loss of consciousness or seizures,” Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, said in a release. “Today's approval … provides individuals living with type 1 diabetes and recurrent severe hypoglycemia an additional treatment option to help achieve target blood glucose levels.”

There are 1.9 million people in the U.S. with Type 1 diabetes. Among them are patients who have difficulty managing the amount of insulin they need to prevent hypoglycemic episodes. They may also develop hypoglycemia unawareness, the FDA said, where they are unable to detect when their blood sugar is dropping. Lantidra is a treatment option for these patients.

What is Type I Diabetes?

Type 1 and Type 2 diabetes are two of the fastest-growing chronic conditions on the planet, and combine to affect more than 34 million people in the US (10.5% of the population).[ii]

Type 1 diabetes is an autoimmune condition in which your body’s immune system mistakenly targets insulin-producing beta cells for destruction.

Type 2 diabetes, on the other hand, is not an autoimmune condition. With type 2 diabetes, your body can produce insulin, but it is not sufficient to control your blood glucose thanks to a condition called insulin resistance.

Much of this is due to poor diet and obesity.

Worldwide there are 537 million people living with diabetes.[iii]

Diabetes is a leading cause of cardiovascular disease, blindness, kidney failure and leg amputation. Israel experiences the most leg amputations, per capita, due to diabetes.[iv] It is projected that by 2045 there will be up to 700 million diabetics. In 2019 there were 4.2 million deaths due to diabetes.

John Campbell, from the UK, put out a video showing that the incidence (new cases) of type 1 diabetes exploded in the younger population beginning with the Covid years. In 2020 there was a 14% jump in the incidence of the disease, and in 2021 there was a 27% jump in the incidence number. That is dramatic. This is worldwide and for people 19 years of age and younger.[v]

This will lead to an increase in the prevalence of type 1 diabetes because once you got it, you don’t get rid of it.

Barring what I am detailing in this newsletter.

Celltrans isn’t the only player in this space. Vertex is pioneering a stem cell treatment. Stem cells have been around for over 20 years, but the FDA is a hidebound, corrupt institution given to preventing these types of treatments from reaching the market. If they did, many of the drugs we have for heart conditions, metabolic disorders and genetic abnormalities would be made obsolete, and established drug companies would lose billions. Let’s just say, the medical establishment has a vested interest in not letting advancements like this reach the market.

For example, a new monoclonal antibody has made it through regulatory hurdles that would delay the onset of type 1 diabetes by half. People would still develop the condition, but it would be delayed. Price tag: $193,000 per year.

Now, if you multiply $193000 times 1.5 million, you get a very interesting number.

Who would want to give that up?

TZIELD is for people 8 years and older with Stage 2 T1D.[vi] It is meant to delay the onset of Stage 3 type 1 diabetes, which is when your body can't make enough insulin on its own and may require insulin injections.

Not to be Debby Downer on the new drug, but a delay is not a cure.

Humacyte would stick an artificial pancreas in your arm, on an out-patient basis.

Conclusion

We are living in clown world, where we pretend that we can’t fix what we can. It seems that the FDA is allowing advances to “trickle” out of the gate. That’s a whole new definition of trickle-down economics, which really doesn’t exist. Just ask Thomas Sowell.

Eli Lilly recently bought Sigilon Therapeutics for a 470% premium, so a big player in the diabetes sphere has dipped its hand into the cellular treatment well. That may bode well for eventually getting something resembling a cure past the bureaucrats at the FDA.

Sigilon’s platform encapsulates engineered cells using the biopharma’s proprietary Afibromer technology, which is designed to shield them from immune rejection. Unlike many cell therapies, the off-the-shelf products do not require patient gene modification or suppression of the immune system, according to Sigilon.[vii] 

Vertex Pharmaceuticals said that, over a year after receiving the company’s stem-cell therapy, two type 1 diabetes patients no longer need to take insulin injections and saw stark reductions in a biological marker of disease.[viii] One of the participants, Brian Shelton, has had positive results. After 150 days, Shelton was able to reduce the amount of insulin he injects by 92%.

For T1D, the stem cells are engineered into insulin-producing pancreatic beta cells—the cells the immune system destroys in diabetic patients, causing hyperglycemia. The goal is to “free patients from constant disease management” by restoring insulin production in their bodies long term.[ix]

I got the inspiration from a band that I listened to in my teen years called Faith No More. They were one of the ephemeral bands from my childhood. The lead singer dresses like a clown, so the video is entirely appropriate. I still have faith in God, but in the FDA, not so much.

[i] https://www.fiercepharma.com/pharma/fda-blesses-celltrans-lantidra-first-cell-therapy-type-1-diabetes

[ii] https://www.masteringdiabetes.org/type1-vs-type2-diabetes/?utm_source=google&utm_medium=cpc&wickedsource=google&wickedid=CjwKCAjw44mlBhAQEiwAqP3eVrVG89TO_0-dpSfIBhyEsJma_9X83rbbtgiGBJsrVjhibSOCmSAXWRoCvFIQAvD_BwE&wickedid=&wcid=16791172744&wv=4&gclid=CjwKCAjw44mlBhAQEiwAqP3eVrVG89TO_0-dpSfIBhyEsJma_9X83rbbtgiGBJsrVjhibSOCmSAXWRoCvFIQAvD_BwE

[iii] https://www.cnbc.com/2022/03/26/stem-cells-may-finally-offer-a-cure-for-type-1-diabetes.html

[iv] https://www.youtube.com/watch?v=UEggGS4vHQU

[v] (1) Dramatic increase in Diabetes - YouTube

[vi]https://tzield.com/

[vii]https://www.biospace.com/article/lilly-to-buy-diabetes-cell-therapy-partner-sigilon-for-300m-/?keywords=type+1+diabetes

[viii] Vertex Pharmaceuticals said Friday that, over a year after receiving the company’s stem-cell therapy, two type 1 diabetes patients no longer need to take insulin injections and saw stark reductions in a biological marker of disease.

[ix]https://www.youtube.com/watch?v=aWQpchPmjeo