Follow-up:

- - -
October 21 2021

Vertex lab-created islet cells
in a membrane packet https://www.fdanews.com/articles/204982-vertex-plans-ind-for-implantable-islet-cell-device-for-type-1-diabetes
- - -

Vertex Pharmaceuticals will submit an Inves-
tigational New Device (IND) application next
year for a drug/device combination that de-
livers insulin-producing, lab-created islet cells
in a membrane packet to protect them from
the body’s immune system.

The subcutaneous device is ready to enter hu-
man trials, according to Felicia Pagliuca, the
company’s Islit expert. It’s a critical part of
Vertex’s core Islit program — a line of stem
cell-derived islet cells (VX-880) that, once ...

... infused, cluster together in the liver and
function as they would in a pancreas, sensing
blood glucose levels and secreting insulin in
the correct amount. ...

On Sunday, February 21, 2021 at 5:34:36 PM UTC-6, _ wrote:

= = = = = = = = = = = = = = = = = = = = = = =
Islit (Insulinitis, near-total to total loss of
endogenous insulin)
o 15 specific types of rapid onset Islit
o 1 slow onset type, Latent Autoimmune Islit
= = = = = = = = = = = = = = = = = = = = = = =

My translation of the article linked to below:

Vertex aims to regulate Islit glucose levels by
restoring pancreatic islet cell function, including
insulin production, with VX-880, an allogeneic,
human stem-cell derived, fully differentiated
pancreatic islet cell therapy.

Unfortunately, that therapy currently requires
long-term immunosuppressive therapy to pre-
vent immune rejection of pancreatic islet cells.

The FDA has approved Vertex to begin a phase 1
/phase 2 study of VX-880. The single-arm, open-
label study will enroll about 17 patients with Islit
who have impaired hypoglycemic awareness (aka
hypoglycemia unawareness) and severe hypogly-
cemia.

Vertex plans to begin the trial in the first half of
2021.

- - -
February 1 2021 https://www.healio.com/news/hematology-oncology/20210201/fda-clears-ind-application-for-stem-cell-therapy-to-treat-type-1-diabetes
- - -

~~~ ~~~ ~~~ ~~~ ~~~ ~~~ ~~~ ~~~ ~~~

INSULINITIS (ISLIT)

New SUPERIOR clarifying name for near-
total to total loss of endogenous insulin https://prohuman.net/pix2/new_superior_clarifying_name_is_INSULINITIS.jpg

The overwhelming majority of Islit caused by
autoimmune attacks on pancreatic beta cells
(Insulitis Islit) but there are

o 15 specific types of rapid onset Islit, a

rare condition (only present in < one-half
of 1% of Americans & in a much lower rate
in most of the world), when present is typ-
ically diagnosed at age under 30
(50% at age < 18, 20% at age 19 to 29)

o 1 slow onset specific type, Latent Autoim-
mune Islit, frequency unknown but per a
recent report, misdiagnosed as Cellosis
(new clarifying name for type 2 diabetes)
almost 40% of the time due to its slow
onset and its occurrence typically at age
over 30

Old outdated anachronistic name for Islit is
type 1 diabetes, confusing in that diabetes
without clarifier is often used to describe
this condition which is 1 of the 7 Disparate
High Glucose Conditions (DHGCs).

That makes figuring out which DHGC is actu-
ally being referred to (and it can be any one,
or some, or all of them when the diabetes
or diabetic word is used without clarifier)
confusing / difficult: https://prohuman.net/pix2/diabetesdiabeticguessinggame.jpg https://prohuman.net/pix2/diabetesdiabeticconfusion.jpg https://prohuman.net/pix2/diabetesdiabeticendingthemisunderstanding.jpg

- - -

Insulin / Insulin Pump / CGM I use

Fiasp Ultra-Fast-Acting Insulin in a
tubeless Omnipod insulin pump catheter
placed into skin / pod with adhesive
stuck onto skin every 80 hours, control
via PDM (Personal Data Manager) https://prohuman.net/pix2/Fiaspinsulin_tubelessOmnipodDASHinsulinpump.jpg

Dexcom G6 CGM (continuous glucose monitor) https://prohuman.net/pix2/Dexcom_G6_CGM.jpg

- - -

Superior Clarifying Names first created
and defined in 2010, trying to replace
outdated anachronistic confusing misleading
diabetes / diabetic / reactive hypoglycemia
words and phrases:

Diabetes Bubble / Diabetes Bubble Burst
Exemplary! https://prohuman.net/diabetesbubblediabetesbubbleburst.htm

C.ure I.nsulinitis A.ssociation
Outstanding! https://prohuman.net/cureinsulinitisassociation.htm

Glucose Anomalies Research regarding
Potential Cures / Improvements in Treatments
Sooner is Ideal! https://prohuman.net/glucoseanomaliesresearch.htm

~~~ ~~~ ~~~ ~~~ ~~~ ~~~ ~~~ ~~~ ~~~

--- SoupGate-Win32 v1.05
* Origin: fsxNet Usenet Gateway (21:1/5)