Thursday, July 17, 2008

Big Doctors Appointment Today - Details on Clinical Stem Cell Trial

So today I go to see if I qualify for a clinical trial that would involve a fairly non-invasive blood and bone marrow transplant for my Crohn's. UPDATE: I AM IN! I GET MY FIRST INFUSION IN TWO WEEKS. TODAY I DID A TB TEST, EKG, BLOODWORK, B12, AND A 1 HOUR INTERVIEW. I HAVE A CT SCAN TUESDAY AND AS LONG AS THAT SHOWS ACTIVE CROHNS I AM READY TO GO. I should qualify based on my lack of response to most other treatments. I think the details below are for the actual study I would be getting involved in. Right now, I have been under quite a bit of stress and am on the brink or at the beginning of a flare-up. I've been eating pretty light and eased off the drinking a bit in an effort to get in shape and keep my Crohn's at bay. I am so used to dealing with the pain by now (without the aid of painkillers for the past few weeks) that I don't even realize how much I actually hurt. I think that mental focus and disassociation keeps me feeling better. As I move forward with my divorce and new relationships I know that I need to take better care of myself and better educate those around me about Crohn's Disease. Sure, I guess it may be embarassing as I move on with dating, etc but the right person isn't going to get caught up in the minutiae and will understand.

Also, thanks to you all for your support of this site. I am proud to be able to educate, assist, and commiserate with you all!

This Phase III study is a multi-center, placebo-controlled, double-blind study of the safety and efficacy of Prochymal™ IV (ex-vivo cultured adult human mesenchymal stem cells) to treat moderate-to-severe, treatment-refractory Crohn’s disease.
Patients who are eligible and willing will be entered into two studies. If there is response at 28 days to protocol 603 and the Crohn's disease activity index (CDAI) is over 220, subjects are eligible to be re-randomized and receive Prochymal in protocol 610. Both protocols 603 and 610 involve four intravenous infusions within 14 days, with a safety follow-ups for two years.
Inclusion criteria:
Inadequate response, lost response, or documented intolerance to steroids, immunosupressants, and biologics (within the past 24 months)
Between 18 and 70 in age
Between 88 and 330 lbs in weight
Diagnosis of Crohn’s ileocolitis, colitis, or ileitis
CDAI between 250 and 450
Exclusion criteria:
Permanent colostomy or ileostomy
Active infection with HIV, hepatitis B or C, or clostridium difficile-associated disease
Obstructive fibrostenotic Crohn’s disease requiring hospitalization within three months of study enrollment
History of total proctocolectomy or subtotal colectomy with ileorectal anastomosis
Prednisone greater than 20 mg per day within 28 days of enrollment


pam said...

i wish i could find out about this and how i could get included in the tesr. write me if anyone has any information

pam said...

would love to be included in this testing . i highly meet the criteria. if anyone knows how i can get included. let me know. thanks Pam

Crohn's Disease Blog