250 Postings And Changes At Work

Last week's blog posting was my 250th blog posting on Current Research into Cures for Type-1 Diabetes!  Also, this year marks the 10th year of publishing the blog, as the first posting was in June 2008  (although I had created a precursor web page in 2006).

Changes At Work

In March I was laid off from my job as a software developer, so I took advantage of the impending job search to think about what I really wanted to do.  And I decided that what I really wanted was to use my software engineering skills to help the day-to-day lives of people with type-1 diabetes.

I limited my job search to companies that were working directly to make the lives of people with type-1 diabetes easier or better in some way.  I'm lucky to live and work in Silicon Valley, so there are several such companies (and non-profits) in the area.  I'm happy to say that starting in late April, I'll be starting as a "Staff Software Developer in Test" for Bigfoot Biomedical.

Several things attracted me to Bigfoot.  First, they are developing an Artificial Pancreas ("automated insulin dosing and delivery solution"), and I'm absolutely convinced that is the quickest path to better treatment, fewer complications, and an easier life for people who need insulin.  Second, their larger goal is to lower the overall burden of type-1 diabetes.   (Not just create a device that is technically better than the competition's, but to create a whole infrastructure of treatment, supplies, and support that is smooth and easy to use.)  Third, their internal software development infrastructure is cool.  It is what I'd expect from a Silicon Valley start up.

So what does this mean for the blog?

I'm not expecting any changes in the blog.  I stopped blogging on artificial pancreas research years ago, so there is no direct conflict of interest.  I won't be blogging on Bigfoot products or the products of competitors.  On the other hand, I will continue to blog about "current research aimed at curing type-1 diabetes" just as I always have.  For me, Artificial Pancreas type devices are treatments and I blog on cures, so there isn't any overlap.

I've already discussed the blog with the Bigfoot team (many are avid readers), and they are very supportive.  Bigfoot wants it's employees active in the type-1 world, and so being supportive of my blog fits into their general philosophy.

How You Can Help This Blog

There are three ways you can help this blog:

• Tell someone about it.  I have zero budget for anything, and that includes publicity, so if you like this blog, the best way to help is to tell other people affected by type-1 about the blog.  If every reader, even just once a year, would tell one person affected by type-1 diabetes about this blog, it would reach 1000s of new readers.  And it doesn't matter if you verbally tell one person, tweet/facebook once, post to a forum or group, or send one email to one person.  It all helps.
• If you read about research aimed at curing type-1 diabetes, which has not been discussed in the blog, then please tell me about it.  My email is below.
• If you have questions about any blog posting or any research aimed at curing type-1 diabetes, please email your questions, or post them as comments to the blog.  These questions tell me what you care about, and they also tell me where I need to spend more time, so they are very helpful to making the blog better in the long term.

Thanks very much for all your support over all these years of blogging.

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, JDCA, or Bigfoot Biomedical news, views, policies or opinions.  In my day job, I work in software for Bigfoot Biomedical.  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.

Stem Cell Educator Starts Two Phase-II Trials

The Stem Cell Educator (SCE) is an attempt to cure established type-1 diabetes by exposing a patient's immune cells to umbilical stem cells, and then returning the cells back to the patient.  Each person had a blood draw, and then a particular kind of immune cell was separated from the blood and specially processed.  The processing phase uses umbilical cord stem cells previously donated by a third party.  The patient's own "educated" immune cells were then returned to the patient.  The stem cells did not go into the person; they were only used for the external processing.

In the last six months, two new studies have started, which I blog on below.  The first is in New Jersey and the second Beijing.

The New Jersey Clinical Trial (NCT02624804)

This study will enroll 10 people.  Everyone will be treated (no control group, no blinding).
The end points are mostly safety related, but there will be some efficiency related end points as well.  There is no mention of collecting efficiency data (such as C-peptide numbers, A1c data, blood glucose, insulin usage, etc.)

This study has started recruiting.  There was hope it would start in mid 2017, but the study needed some lab infrastructure which the medical center did not have at that time, hence the delay while the new labs were set up.

Recruiting at one site: Hackensack University Medical Center
    Hackensack, New Jersey, United States, 07601
    Contact: Mariefel Vendivil    551-996-5828    Mariefel.Vendivil@HackensackMeridian.org 
    Contact: Andrea Ortega    551-996-3923    Andre.Ortega@HackensackMeridian.org 

Clinical Trial Records: https://clinicaltrials.gov/ct2/show/NCT02624804
But note that this clinical trial record is out of date.  The study has not yet started recruiting, no efficiency end points are listed, and the completion dates are too short.

The Beijing Clinical Trial (NCT03390231)

This study will enroll 100 people.  Everyone will be treated (no control group, no blinding).
The primary end point will measure specific immune cells (which are involved in type-1 diabetes) one month after treatment.  Secondary end points will cover insulin sensitivity after a month, and A1c, blood glucose, and c-peptide measurements after three months.

They started in Nov-2017, and hope to finish in either July-2018 or Dec-2020 (see discussion below).

Recruiting at one site: Department of Endocrinology, Chinese PLA General Hospital
    Beijing, China, 100853
    Contact: Yu Cheng, MD,PhD    86 10 55499301    chengyu_301@163.com 
    Contact: Yiming Mu, MD,PhD    86 10 55499301    muyiming@301hospital.com.cn 

Clinical Trial Records: https://clinicaltrials.gov/ct2/show/NCT03390231

Discussion

Differing Results: This treatment has been previously tested twice before.  One of these clinical trials had strong results, but the other one had very weak results.  I've blogged on these in the past:
http://cureresearch4type1diabetes.blogspot.com/search/label/Stem%20Cell%20Educator

The researchers believe they understand why the two trials had different results, and are hoping to apply this knowledge to the current two trials, in order to get better results.

Date confusion: The FDA's clinical trial registration page requires researchers to list three dates for a clinical trial: start date, primary completion, and study completion.  (Once the trial starts, the first is known, while the second two are estimated.)  The primary completion date is when the last data for the primary outcome will be gathered.  The study completion date is when the last data for the study will be gathered.

For the Beijing study, the primary completion date is May-2018 and the study completion date is Dec-2020.  However, the primary end point is a month after treatment, while the secondary end points are either one or three months after treatment.  So that means the study completion date should be two months after the primary completion date, not 2 1/2 years!  My guess is that there are some two year end points as well, which are not listed in the clinical trial registry.   (The New Jersey trial also has two year end points which are not listed in the registry database.)

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.