Sunday, October 28, 2012

Zhao Starts Phase-II Clinical Trial of "Stem Cell Educator"


Zhao Upgrades His Clinical Trial to Phase-II

I've previously blogged on Zhao's work here:
http://cureresearch4type1diabetes.blogspot.com/search/label/Zhao

He published his phase-I results in January 2012, and in July, he changed the basic nature of his clinical trial record from phase-I/II to phase-II.  Change a trial from I/II to II is uncommon, but it does happen. (The more common thing is to create a new clinical trial for the phase-II study.)  But the whole point of a I/II trial is that it can turn into a II if things go well.  In January, Dr. Zhao published data on 12 treated patients and 3 placebo patients, but the clinical trial record was for 100 people, so the remaining 80+ people (I assume) will be his phase-II trial.

Notice that it took him only 6 months to "turn around" from publishing his phase-I study to starting the phase-II study.  That's quicker than most research I follow.

The trial record was also updated in Augest and October, so if you group together all the changes made, here is a summary of the changes:
  • Phase goes from 1 to 2.
  • A second trial site has been added.  In addition to China, patients in Spain can enroll at Hospital Universitario Central de Asturias.
  • Purpose goes from "Safety/Efficacy" to "Efficacy" Study.
  • The study was expected to complete in 2012 now is expected to complete in September 2014.
  • Sponsor goes from University of Illinois to Tianhe Stem Cell Biotechnologies (Zhao's company).
  • Trial design went from single blind to open label, and 
  • There is no mention of a placebo or control group.
Also, Tianhe (Zhao's company) has also started a separate clinical trial aimed at using this same technology to cure/treat Alopecia Areata, which is another autoimmune disease involving T-cells. The trial is being run in China.

Finally, another researcher (Dr. Mark Atkinson) has been funded by JDRF for a year to test Dr. Zhao's Cell Educator "ex vivo" (not in living organisms, but in tissue samples or similar). The goal is to independently verify parts of Dr. Zhao's results.  You can read details here:
JDRF "lay abstract": http://onlineapps.jdfcure.org/AbstractReport.cfm?grant_id=38534&abs_type=LAY

Discussion

From my point of view, there is both good and bad news here.  Going from single blind to open label is a step backwards, in my mind.  Not having a placebo group is also going the wrong direction.   On the other hand, another site, more people, and an end point in the near future are all good things.

Corporate web site: http://www.tianhecell.com/
Clinical Trial Record: http://www.clinicaltrials.gov/ct2/show/NCT01350219

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.
Clinical Trials Blog: http://cureresearch4type1diabetes.blogspot.com
Cured in Mice Blog: http://t1dcuredinmice.blogspot.com/

9 comments:

GabLarConBriCar said...

I see this as the most promising cure related initiative. It is sad to see Zhao leaving the US and doing it all in China though.

Himanshu Narula said...
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Gonzo said...

No problem, I have been treated in China and it's nice there, you could visit Hainan or in the spring or autumn, Shanghai or Hong Kong.

Tiffany Walker said...

How can someone in the US get this cure? If someone has already been treated the. shouldn't it work? I've been told there isn't and never will be one?

Tiffany Walker said...

Can someone please reply about my question... I'm in the us And trying to find somewhere who has the cure for type 1 diabetes.

Tiffany Walker said...

I oukd really like to know how to get a cure in the US ... or even find somewhere to test one

Tiffany Walker said...

Did you live in China when you were treated?

Joshua Levy said...

Tiffany: there is no cure for type-1 diabetes right now. Not in the US not anywhere else. As far as I know Dr. Zhao has not cured anyone outright.

Actually, that's not quite true. There is some research in Brazil and it has also been done in Poland and China, were people who were diagnosed for less than 6 months, oftentimes did not need to take insulin for years. But it involved "rebooting" your immune system, and does not have a good safety profile. (Although I don't know that anyone has died from it yet, that is a possibility.)

I have blogged on this before. Look under Burt and Snariski:
http://cureresearch4type1diabetes.blogspot.com/search/label/Burt

But other than that -- which is not generally available -- there is not a cure out there.

Joshua

John Dudley said...
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