Thursday, November 10, 2011

Results from Trucco's Phase-I Dendritic Trial

This is another "is the glass half full or half empty" kind of result. 

This experiment was started in 2007.  People who had type-1 diabetes for more than 5 years were treated by removing dentric cells, treating those cells, and then reinjecting them.  This was done 4 times (2 weeks apart).  About 10 people were treated, but there was no placebo group.  This study was a phase-I trial, very clearly aimed at safety, not effectiveness.  As far as I know, this is the first clinical trial aimed at type-1 diabetes, which used this basic method (of reinjecting a patient's specially treated dendric cells).  So there were new and unique safety issues to be tested.  Just recently a second study using this same basic technique has started which you can read about here:

This is from the abstract:
CONCLUSIONS Treatment with autologous dendritic cells, in a native state or directed ex vivo toward a tolerogenic immunosuppressive state, is safe and well tolerated. Dendritic cells up regulated the frequency of a potentially beneficial B220+ CD11c− B-cell population, at least in type 1 diabetes autoimmunity.
My translation is is this:
First, there were no safety issues.  The treatment's safety was good.
Second, there were some effects (which they think are good) on a particular type of B-cell.
Third, there were no other effects seen (so no changes in C-peptide levels, A1c, or T-cells, for example).

What does this mean?

The most important  results, is that the treatment is undoubtedly safe enough to continue into phase-II trials.  (In the presentation below there is a letter from the FDA saying that.)

But after that, did it work?  Very hard to tell, but it did not work as measured in the obvious ways by raising C-peptide levels, for example, or lowering antibody levels. The researchers hope that the change in B cells is a good sign, but I'm not sure that it is.

It is important to remember that B-cells and T-cells come in all different types.  So when these researchers say B220+ CD11c− B-cells they are referring to one type specifically.  They hope that more B-cells of that specific type are a good thing, but this trial alone does not show that is so. For comparison, the most talked-about type of B cell is called CD20.  T cells that are researched as part of type-1 research include CD4 and CD8 (and many more).  I know of no other clinical trials working with this type of B-cell.

Clinical Trial Record:

Joshua Levy
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. 
To Get as Email Join here:

No comments: