Summary of Three Months of New Trials
This is a quick summary of all of the new clinical trials into type-1 that started between July 1st and October 1st, 2012. These are trials which were entered for the first time during these three months. I got this list from the FDA's clinical trial database, which is on line here:
37 New clinical trials in total
14 Delivery / New Insulins / New Test Kits
06 Long Term Side Effects
03 Artificial Pancreas
08 Other (1 of these was a Vitamin-D trial)
My only comment is that only one of these (the AAT one) might lead to a cure. That's not a lot.
What's Up with AAT (alpha-1 antitrypsin)?
The new AAT study reminded me that there are now a total of five AAT studies ongoing, and that's enough to have a summary of AAT research, so here it is.
I've blogged on AAT before, here:
and some background on AAT is here:
Study Number Phase Size Sponsor Duration Completion Date
NCT01304537 I 24 Kamada 1 year November 2012
NCT01319331 I 15 Omni Bio 2 years September 2013
NCT01183468 II 16 NIAID 2 years November 2014
NCT01183455 II 66 NIAID 2 years November 2014
NCT01661192 II 24 Kamada 3 years December 2016
Initially, that looks pretty good. Unfortunately, one of these trials (the second one, by Omni Bio) released some early data, and this data was only slightly positive. The treatment showed no benefit to people with established type-1, and relatively small improvements to people who took it soon after diagnosis. No specific numbers were published, which I consider to be a bad sign. The first complete study (Kamada's) should be done very soon, and that should give us a much better "feel" for the level of success. By 2015 we should have results on four studies, which should be definitive.
Another Trial for Zhao's Cell Educator (if they raise money)
I've previously blogged on Zhao's work here:
It looks like researchers in New Zealand are raising money specifically to replicate Dr. Zhao's work.
Here is their description of what they want to do:
In the first trial we would infuse activated stem cells back into the patient and measure their ability to switch the behaviour of aggressive T lymphocytes to ‘peaceful’ T regulator cells. Trials like this are occurring internationally but without the activation step, and results are not yet clear. The second trial will be similar to the Chicago study [Zhao's trial, which was actually done in China]. The stem cells from each person will be used in the laboratory to ‘condition’ their white blood cells in the laboratory, before re-infusing the white blood cells.I don't usually put information about donating money in my blog posts, but I've gotten several requests for information on how to help fund Zhao. I don't know how an individual can do that effectively, but the researchers in New Zealand have these instructions:
If you would like to make a donation towards this cause, then the Spinal Cord Society NZ website www.scsnz.org.nz provides a means for you to do that. An email plus a donation will ensure that your contribution goes only towards the joint SCSNZ-Diabetes research work.Please remember: I know nothing about these guys or this organization. I am not endorsing them!
I want to especially thank Brian Braxton for the information and sources he provided, and everyone else (there were several) who pointed this news out to me.
All the views expressed here are those of Joshua Levy, and nothing here is official JDRF or JDCA news, views, policies or opinions. My blog contains a more complete non-conflict of interest statement.
Clinical Trials Blog: http://cureresearch4type1diabetes.blogspot.com
Cured in Mice Blog: http://t1dcuredinmice.blogspot.com/