Unsuccessful Phase-I Clinical Trial of Beta-O2's Encapsulated Beta Cells
Encapsulated beta cells are implanted devices. The encapsulation coating allows blood sugar in, and insulin out, but does not allow the body's immune system to attack the beta cells. It also allows nutrients in and waste products out. This allows the beta cells to naturally grow and to react to the body's sugar by generating insulin which goes into the body's blood system. Meanwhile, the body's autoimmune attack cannot target these beta cells, and you don't need to take any immunosuppressive drugs (as you would for a normal beta cell transplantation). I previously blogged about this trial here:
https://cureresearch4type1diabetes.blogspot.com/2014/11/beta-o2-starts-phase-i-trial-and-update.html
Unfortunately, they published unsuccessful results last year. To quote their abstract:
Implantation of the βAir device was safe and successfully prevented immunization and rejection of the transplanted tissue. However, although beta cells survived in the device, only minute levels of circulating C-peptide were observed with no impact on metabolic control.Encapsulated beta cells have been an active area of research for over 20 years. Currently ViaCyte and Sernova are both active in clinical trials in this area, and there are other contenders testing in animals.
Abstract: https://www.ncbi.nlm.nih.gov/pubmed/29288549
Full Paper: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6055594/
Clinical Trial Record: https://www.clinicaltrials.gov/ct2/show/NCT02064309
The Phase-II? Clinical Trial of Ladarixin Is Fully Enrolled
Ladarixin targets two specific immune system chemicals: IL-8a and IL-8b. The idea behind this trial is that suppressing this part of the immune system will stop the autoimmune attack which causes type-1 diabetes. I previously blogged about this study here:
https://cureresearch4type1diabetes.blogspot.com/2016/08/ladarixin-starts-phase-ii-clinical-trial.html
This study finished recruiting in June-2018, and they now expect to complete in Oct-2019.
Clinical Trial Record: https://www.clinicaltrials.gov/ct2/show/NCT02814838
Fully enrolled is an important milestone for two reasons. First, because it is now possible to predict when they will finish collecting data. Second, because much of the uncertainty that surrounds clinical trials, is involved with recruiting participants. It is often unclear how hard it will be to recruit people, and how long it will take. But that this point, all that uncertainty is behind the researchers. From now on, it is just gather data, then analyze data, and then publish data. Researchers have a lot more control over those later stages, then over recruiting people in the first place.
Coffee In Pilot Clinical Trial To Improve Renal Function
I will not be following this trial, because it is aimed at long term complications of T1D, not a cure. But it sounded like so much fun, I'm mentioning it here. Apparently caffeine changes renal (kidney) function in some unique ways which are not duplicated by other drugs. The researchers think that a coffee in the morning might improve kidney function in a way that helps people with T1D.
They are testing this in teenagers (12-21 years old). It is a 10 person, open label, no control group trial, which is enrolling by invitation only. You need to already be participating in a different trial (called "CASPER") to get invited. They drink Starbucks® cold brew every morning for 6 days. Kidney function will be tested on the 7th day. No word on the Peet's® version.
Clinical Trial Registry: https://clinicaltrials.gov/ct2/show/NCT03878277
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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