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)