A significant number of individuals with Crohn's disease do not find relief with existing steroidal, immunosuppressive, or biologic therapies, and are forced to seek surgery or other drastic measures for treatment.
PROCHYMAL[tm] adult human stem cells are manufactured from healthy, volunteer donors, extensively tested, and are stored to be available as needed. Human and animal studies have shown that the cells do not require any donor-recipient matching. The cells may have both immunosuppressive and healing benefits in Crohn's disease. The cells naturally migrate specifically to sites of inflammation, so their effects are believed to be local and self-limiting rather than systemic.
Osiris Protocol 603 is enrolling subjects to evaluate the ability of PROCHYMAL to induce remission in subjects with moderate-to-severe disease (Crohn's disease activity index -- CDAI -- of between 250 and 450, inclusive) who have failed or been intolerant of at least one drug in each of the steroid, immunosuppressant, and biologic classes.
There was an article in the Chicago Tribune a couple weeks ago that Prochrymal was approved by the FDA to treat terminally ill children with cancer. It has also been made fast track status by the FDA. Apparently from what I read the Phase 3 testing is coming to and end in the next couple of months and if all goes well look for FDA approval at the end of this year or beginning of 2009. there's a ton of info about this online. Not trying to get anyone's hopes up but looks very promising to take the place of some of the harsher treatments we have.
Post Edited By Moderator (CrohnieToo) : 6/9/2008 6:07:58 PM (GMT-6)
Post Edited (Puccini) : 6/10/2008 11:12:38 AM (GMT-6)
Post Edited (Puccini) : 6/10/2008 1:08:06 PM (GMT-6)