Friday, December 5, 2008

New to Me: Phase-I Clinical Trial of Polyclonal Anti-T-Cell (ATG)

This clinical trial treats honeymoon diabetes (during first 6 weeks) with ATG. The hope is for some beta cell preservation. This is a prelude to Gitelman's phase-II ATG trial, described here:, except that this trial is still ongoing. However, they have published interrum results (on their first 17 patients) here:

My eyeballing of the interrum results looks like the ATG group used about 60% as much insulin as the untreated group after about 12 months, and this seemed pretty stable. It did not look to me like the effect was "wearing off". This was good enough to motivate a follow-on, phase-II clinical trial, which is currently underway. I'm also very interested in what happens to these 17 patients after 2 years, 3 years etc. If the lower insulin requirement gradually goes away, that's too bad. If it stays stable, then that is very promising. If it gets even better slowly over time, that suggests that the body is growing new beta cells, and would be good news both for ATG treatments and for many others.

US Government Clinical Trial Record:

Estimated Enrollment: 28
Study Start Date: November 2000
Estimated Study Completion Date: December 2007

This work was sponsored by the Ministry of Health, Czech Republic, and is being done in Prague.


Anonymous said...

All attempts to cure this disease are good news. For your information, there is a human clinical trial on a potential cure for diabetes being run at Massachusettes Hospital, Boston under Dr Nathan and Dr Denise Faustman from Harvard. They are investigating a possible cure which, potentially (if the trial is successful) would help all diabetics even if they have the disease for years. More information about the Phase I trials is available at

Joshua Levy said...

I written extensively about Faustman's research here:

Her research has many serious flaws. You point out that her research "help all diabetics even if they have the disease for years". She is not the only researcher to do this: both Osiris and LCT's cures would help all diabetics, and they are both farther along, and have not had the research mistakes that Faustman has had.