This blog posting is a summary of four small updates. Unfortunately, they include research delay, two unsuccessful trials, and one trial unreported for so long that I'm now assuming that it failed.
Tianhe Delays Phase-II Trial of Stem Cell Educator
You can read my previous blogs on Tianhe's Stem Cell Educator here:
The
quick summary is that the stem cell educator is a machine which takes
the immune cells from a person's blood, exposes them to various organic
molecules which change their behavior so they learn not
to attack beta cells. The cells are then returned to the body.
Unfortunately,
the new news is that clinical trials for the Stem Cell Educator have
been delayed by three months because of the COVID-19 pandemic. You can
read the announcement here: https://www.facebook.com/tianhecell/posts/1149765802041857
I
suspect that some other clinical trials are getting delayed as well,
but since there is no central clearing house for these kinds of
announcements, it is hard to know for sure.
Also
new (to me) is that Dr. Zhao has a fund raising page through the
hospital where he does his research. So if you want to fund his
research directly, you can do it here:
https://secure2.convio.net/humc/site/Donation2;jsessionid=00000000.app20058a?4622.donation=form1&DONATION_LEVEL_ID_SELECTED=1&NONCE_TOKEN=F031AB361B3FAE40A58FDBF166E9EE74&df_id=4622&idb=0&mfc_pref=T&fbclid=IwAR0fYn6E7Y--EzfHeoR5rcNLKdQK-3WWUrgywEZH6zPZEVx2EI8N87tg6XoUnsuccessful Phase-II? Study of Albiglutide
Albiglutide (tradenames Eperzan and Tanzeum) is a GLP-1 inhibitor, similar to Byetta, Victoza and other drugs commonly used by people with type-2 diabetes. GlaxoSmithKline tested it in people with type-1 diabetes, to see if it had the potential to delay T1D or cure them.
Unfortunately, it was not successful. Their conclusion was:
In newly diagnosed patients with type 1 diabetes, Albiglutide 30 to 50 mg weekly for 1 year had no appreciable effect on preserving residual β-cell function versus placebo.
I previously blogged about this research here:
Clinical Trial Record: https://clinicaltrials.gov/ct2/show/NCT02284009
Wikipedia: http://en.wikipedia.org/wiki/Albiglutide
Wikipedia: http://en.wikipedia.org/wiki/Albiglutide
Unsuccessful Phase-II for Low-dose IL-2
Interleukin 2 (IL-2) is a protein that the body's immune system uses for communications. It is part of the system that helps the immune system identify the body's own cells from foreign cells. Since the root cause of type-1 diabetes is a failure in this process, IL-2 is a possible cure.
This study enrolled 24 children in their honeymoon phase into 4 different groups: one placebo group and three different treatment groups. The primary outcome was higher levels of a specific immune cell called a Treg cell. Higher levels of Tregs are thought to help prevent T1D. Secondary outcomes included direct measures of T1D: how much insulin the person produced naturally (as measured by C-peptides) and A1c numbers.
The study showed that treated honeymooners did generate more Tregs. This result was statistically significant and was higher in the higher dose treatments. However, the secondary outcomes (which measured effect on T1D symptoms) were not statistically significant.
In 2016, I published a blog which was a summery of the 6 clinical trials using IL-2 at that time:
You can read all my blogging on IL-2 here:
My informal summary of all this research is that IL-2 causes more Tregs to be generated, but does not cause more insulin to be made, or impact A1c. The key measure of progress to a cure is how much insulin a person is naturally creating and (so far) IL-2 is not increasing that.
Clinical Trial Registry: https://clinicaltrials.gov/ct2/show/NCT01862120
Unsuccessful Phase-I Study of Ustekinumab and INGAP: No Results After Three Years
My policy is that any study which has not published within two years of completion is unsuccessful. My experience has always been that studies that are successful are published quickly: within one year. So when a study goes three years, as this one has, without publishing its results, I'm very comfortable assuming that it was unsuccessful.I have tried, more than once, to contact the researchers involved to get an update, but never got a reply.
Previous Blogging: https://cureresearch4type1diabetes.blogspot.com/2016/01/exsulin-ustekinumab-combo-starts-phase.html
Clinical Trial Registry: https://www.clinicaltrials.gov/ct2/show/NCT02204397
Joshua Levy
http://cureresearch4type1diabetes.blogspot.com
publicjoshualevy at gmail dot com
All the views expressed here are those of Joshua Levy, and nothing here is official JDRF or JDCA news, views, policies or opinions. My daughter has type-1 diabetes and participates in clinical trials, which might be discussed here. My blog contains a more complete non-conflict of interest statement. Thanks to everyone who helps with the blog.
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