HealingWell
Search Close Search
☰

Anybody on Prochymal??

Support Forums
>
Crohn's Disease
✚ New Topic ✚ Reply
❬ ❬ Previous Thread |Next Thread ❭ ❭
Posted 1/16/2011 2:31 AM (GMT 0)
I was on Prochymal back in March of 2008. Seemed to work well, but the trial was discontinued while I was in it. Now I am on Tysabri and I guess all I can say is that i am "hanging in there. I heard that they restarted the trial for Prochymal recently though, and am interested in hearing if anybody is having luck with it this time. I really felt like the rug was pulled from under my feet while I was on it. In the sense that I felt like i was starting to heal , and then they told me I couldn't receive the medicine anymore. I really hate this disease and just have been feeling really down lately. I cant seem to have a normal life and am frustrated that I cant plan to go on vacations or even get married, because I am always worried about my health turning south on me. I try to stay positive, but its hard to be positive when there are so many negatives. i really just worry about my future and people just don't understand how hard it is to deal with this disease every day of your life.
Posted 1/16/2011 3:40 AM (GMT 0)
Hi there, Northernguy... You and I share that feeling of disappointment! I believe we were in the trial about the same time... There is someone on the board right now who just started it a month or so ago. They restarted and ... sad for you and I, but good for new trial entries, is that the 610 arm is now an open-label. :-( I called Osiris and they said that I've already participated in the trial, so I cannot get open label, which we had (if we responded in 603) but ours was re-randomized.

However, the new open label is only 8 treatments, not continuous as needed until approved. Or even for 2 years to come. Just the 2 more series of infusions over a 2 year span.

Osiris has submitted to FDA (I think!) for GvH disease, not sure how that's going to turn out. Technically their poor trial design really flawed (in my opinion) the results. I just hope they can pull off an approval! They did tell me they have about ~110-120 patients left to enroll. They do not need to gather 2 years of data on those ~110-120 participants, just 30 days worth. So they were hoping to get a submission ready in a year and a half or so. Still fast track, so we should know ... one day. Love to hear updates from anyone else with more recent contact.
Posted 1/16/2011 1:56 PM (GMT 0)
I'm in the new trial. I received 3 treatments last month, had no response, and assume it's because I got the placebo. Was only a 50-50 chance of getting the real treatment. I start the open label this week so I'll be getting the stem cells for sure. The open label is only 3 treatments over 4 months.

Interestingly, I was in the Tysabri trial years ago before it was approved. I got 2 treatments and was feeling great then they stopped the trial (because someone died from PML). I know how you feel to have the rug pulled out. Hopefully they will learn and some of these new treatments will get approved
Posted 1/16/2011 3:25 PM (GMT 0)
Good to hear of others on the medicine also. Long time no see to you sr5599. Hopefully, one day soon this is approved ,and we can begin to take it again. I know I felt a difference while I was on it. Wonder if we can get it off-label when and if they approve it for GVHD?
Posted 1/16/2011 3:27 PM (GMT 0)
Oh , forgot to mention this . In my opinion, it is a crime to have a medicine that is working for somebody that is seriously very ill, and then take the medicine away from them. Its just criminal!!
Posted 1/16/2011 8:32 PM (GMT 0)
Thanks for the update, Dave123... Glad you corrected me on the 610 open label structure. 3 treatments- I am interpreting that as 3 infusions? In the old trial structure we were given 4 infusions as a part of a series - days 0,3,7 and 14. Sounds like that changed too.

Northernguy - I'm planning to look into off-label once it's approved. I'm sure it wouldn't be covered by insurance which will probably put it way out of reach. It's worth looking into though. Aside from the money to run an open label trial, it sure seems like it would be beneficial to keep a few of us on open label as proof of efficacy. I feel frustrated for sure that I can't take the med knowing how well it works. Last summer my surgeon and GI were after me to do a permanent ostomy. I just can't do permanent knowing how well prochymal worked for me... I'd definitely do a temp while I wait, but... they won't do that. Oh well, boo hoo. ;-)

The great news is that the trials are back up and running and people like Dave123 are participating. I can't wait to hear how the open label goes for you Dave! Good luck!
✚ New Topic ✚ Reply