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ivy6
Elite Member


Date Joined Sep 2005
Total Posts : 10404
   Posted 12/6/2007 10:01 PM (GMT -7)   
What happened once you stopped the Prochymal? Did you get sick again? How long did you get relief for?

It's terrific to have someone here who's used the drug. We've been excited about it here for a long time now.

Ivy.
Co-Moderator Crohn's Forum.


sr5599
Veteran Member


Date Joined Aug 2007
Total Posts : 1202
   Posted 12/6/2007 11:20 PM (GMT -7)   
Honestly, I think it's really worth being excited about. But, my experiences are still far from what could be, I believe. The study is set up so that there are two phases. If a person responds (CDAI decrease > 100) in the first round, they are moved on into the second phase. They are re-randomized in the second phase of the trial.

In the first phase of the trial I was/am convinced that I got a dose of the real cells. I noticed it within days (internally -- less gurgling, more settled -- those kind of feelings). The score itself came down quickly after that. Bathroom trips cut in half, pain nearly gone. As I said, I healed (according to the study doc via colonoscopy at Day 0 and Day 28) 50-60% in 28 days. That is amazing to me, the girl who doesn't respond to any drugs! But, it was still only 50-60%. So, we immediately started in on the second phase. Unfortunately, after being re-randomized (1/3 of placebo), I do not feel what I felt before. No new progress has been made. But, so far, my CDAI is remaining stable with the effects of the first round. So, I was at 367 when I started and seem to have stablized around 230 after the first round of infusions. The second round, as I said, has had no effect up or down. I am still so much better, but not in remission. I feel like, if I had the high dose each time, I would have been healed by now. It really was amazing, the difference.

That's just my experience. I believe it's a promising new advancement and can't wait until it's approved! There have been very few people enrolled in Phase III, so if you qualify and are considering a trial, contact Osiris to find your nearest study center! (Must not tolerate or respond to one drug in each category: steroids, immunosuppressants, biologics. (Failing without allergic reation qualifies, too, I believe) The quicker the trials complete, the quicker they can submit!! ;-)

ivy6
Elite Member


Date Joined Sep 2005
Total Posts : 10404
   Posted 12/7/2007 12:45 AM (GMT -7)   
Hi Shari,

I qualify... but unfortunately I'm in Australia. We're a long way behind the US in getting drugs approved for use, and even once they are approved, it's a long time before most of us can access them because they take forever to be subsidised.

That's really exciting, though, especially as you've maintained your improved health, even without the drug. And how wonderful and encouraged you must feel to know that SOMETHING works for you at last.

I have lots more questions but my hands are playing up and making typing difficult - one important one, though: what happens to you now?

Thanks for replying!

Ivy.
Co-Moderator Crohn's Forum.


sr5599
Veteran Member


Date Joined Aug 2007
Total Posts : 1202
   Posted 12/7/2007 11:01 AM (GMT -7)   
Hi Ivy,

Thanks for sharing the excitement. It is definitely encouraging. For the people not aware of what Prochymal is, I suppose I could say more about the drug! It's a stem cell infusion derived from adult mesenchymal stem cells -- taken from adult bone marrow donors between the ages of 18-30. One single bone marrow donation can create up to 5,000 infusions. They wash the cells and take a variety of donor cells so that there is a neutral "type" and virtually zero chance of rejection. Any cells that are rejected are simply passed through, without any reactionary situation.

The infusions last one hour, but they observe the patient for 2-3 hours after. And, there is a good 1-2 hours wait ahead, as they are stored frozen in a local blood bank and are not set out to defrost until the patient actually shows their face. (No sense wasting good stem cells!) The are frozen with the preservative called DMSO, so the patient smells like creamed corn or garlic (depends on the sniffer) for about 36 hours after each infusion. Personally, I only caught a brief wiff of it once. Other than that, I never smelled it on myself. My daughter would run from the room with her nose plugged, though, so I know it's quite overwhelming that first day! ;-) But, as I told the trial coordinator, us Crohnies are up for pretty much anything if it promises to help! What's a little creamed corn!

As for what happens for me now, nothing really. I am still eligible to receive one more round (4) of infusions and will likely do that in early January. The way they determine when to administer is when the CDAI goes above 220, indicating a flare. I am there now, but with the holidays and the fact that I live 3-4 hours away, I will wait until the holidays are over. After that round of infusions I am done, except follow-up blood work and, at one and two years down the line, a CAT scan. From what I understand, they expect the results of the drug to be long-lasting. For me, if I only heal 50-60%, it's unclear if the sections of the bowel that healed will remain disease free for a while, or whether the disease will take over again. There are no plans for any extension/open-label trial at this time. (I am still hoping!) Osiris said that if they ever add that, it will be a couple years down the line.

They are doing two different phase III trials, and, sadly, have just begun enrollment on the first. I am very, very eager for this drug to hit the market. So far the drug has been used in ~250 people -- spread among heart patients, knee injury patients, Crohn's patients, and Graft vs. Host Disease (which is what it was first line treatment for). But, it is designated as both "fast-track" and an "orphan drug" with the FDA.  No serious side effects have been observed, though there are some scary "potential" effects of stem cells in general. Overall it feels safer to me than something like Tysabri (which I am still looking forward to being approved!)... The whole thing feels a bit like science fiction to me still!

Post Edited (shari5599) : 12/7/2007 11:01:30 AM (GMT-7)

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