Does any anybody know the current status of "Prochymal" Stem Cell research

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Iram
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Date Joined Jul 2003
Total Posts : 145
   Posted 6/17/2009 9:58 AM (GMT -7)   
There was thread here that suggested that the study failed. Any updates?

jmiller056
Regular Member


Date Joined Feb 2009
Total Posts : 57
   Posted 6/17/2009 12:07 PM (GMT -7)   
I haven't heard anything since Osiris announced that there may have been a design flaw in Phase 3. That was back on March 27. You can read about it on Osiris' site at: http://investor.osiris.com/releasedetail.cfm?Releaseid=373471 Hopefully the was the cells do work, and a Phase 4 gets going quickly!
23 y/o Male; Dx Crohn's Disease in 2001 at age 14.
Lost 3 inches of colon and 7 inches of ileum in 2004 bowel resection.
CD returns in October 2008, Starting the Maker's Diet June 17, 2009
Current meds: Pentasa: 3000 mg; Fibercon: 2 pills 3x; Imodium: 2 pills 3x
Been on: Prednisone, Flagyl, Cipro, Imuran, Entocort, Remicade
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Reef08
Regular Member


Date Joined Dec 2005
Total Posts : 267
   Posted 6/17/2009 12:17 PM (GMT -7)   
There's nothing going on right now. No word on when the new Phase 3 trial will start. So much for it being fast-tracked by the FDA.

This drug looked like it was going to be the next big breakthrough in treatment and as our luck would have it, it gets delayed by a couple of years. It'll be a couple of years before the next group of drugs are approved.

vls
Regular Member


Date Joined May 2005
Total Posts : 166
   Posted 6/17/2009 1:42 PM (GMT -7)   

I'm currently in the study and it is officially over, according to the drs and nurses overseeing me in the study.  They have moved on to other trials (interleukin 18)  Osiris' stock plummeted, apparently after the news of the failed prochymal trial and future funding is questionable.  They continue to monitor those of us already in the trial for two years, why, I don't know, and neither do the drs.  They are done with it.  BTW, I'm waiting to find out if I developed Graft vs Host disease from the stem cell infusions.  I have to wait two weeks for the biopsies to come back because Osiris will not unblind the study to find out if I really did get the stem cells, but it sure is beginning to look that way.  Even if it would become available at some point, this therapy is not for me.

 


ivy6
Elite Member


Date Joined Sep 2005
Total Posts : 10404
   Posted 6/17/2009 3:08 PM (GMT -7)   
(((v.scho))) I'm so sorry.

:-(
Co-Moderator Crohn's Forum.

New meds thread


Reef08
Regular Member


Date Joined Dec 2005
Total Posts : 267
   Posted 6/17/2009 3:38 PM (GMT -7)   
v.scho said...
I'm currently in the study and it is officially over, according to the drs and nurses overseeing me in the study. They have moved on to other trials (interleukin 18) Osiris' stock plummeted, apparently after the news of the failed prochymal trial and future funding is questionable. They continue to monitor those of us already in the trial for two years, why, I don't know, and neither do the drs. They are done with it. BTW, I'm waiting to find out if I developed Graft vs Host disease from the stem cell infusions. I have to wait two weeks for the biopsies to come back because Osiris will not unblind the study to find out if I really did get the stem cells, but it sure is beginning to look that way. Even if it would become available at some point, this therapy is not for me.


That's really strange about the GVHD. As far as I know, GVHD only occurs during stem cell transplants when the immune system is knocked out by chemo, not from adult stem cell infusions. This is the first I've heard about it. Why would the doctors think you have it?

vls
Regular Member


Date Joined May 2005
Total Posts : 166
   Posted 6/17/2009 4:00 PM (GMT -7)   
GVHD was mentioned repeatedly in the consent forms I had to sign. I have a "dis-coloration" on my abdomen that is pretty horrific looking. It was preceded by itching and then a rash that began during the infusions. I can't count how many drs have looked at this and had no idea what it could be until finally one dermatologist suspected GVHD. I'll know in a couple of weeks.
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