Osiris Prochymal First Phase Complete

Well, I am definitely feeling a bit different. I think better?? All of the stress i am going through would normally propel me like a rocket, straight into (or is it ass backwards into) a flare up. I believe the fact that my Crohn's is not flaring, despite the fact that I am not on ANY other medication (aside from the Osiris Prochymal) looks good. I am still having pain and all of that good stuff but it is just "different." I wish I could be more descriptive, but words fail me. I have never been too good at being in tune with my Crohn's...I kind of just deal. On the negative side, my body is a wreck from sports and the stem cells should theoretically be helping me out a bit with muscle soreness and issues. My knee is shredded and I need to have surgery, and my back is still giving me fits. Every day I play soccer (injuries have kept me out a full week as of tomorrow) I have another strain or pull. Maybe its just the old age. At any rate, I have a follow up docs appt next Thursday and we'll see where we go from here!

-Scottie

Stem Cell Transplant Starts Tomorrow - Osiris Prochymal

Tomorrow is my first infusion/transfusion Prochymal. I am really nervous. I am in the Phase III study. Prochymal is in clinical trials and not yet an approved and marketed therapy. To date, MSCs have been tested in multiple indications in over 400 patients and no major safety concerns have been encountered.

Many of the readers of this Crohn's Blog have asked me how they can participate.
For more info, please send an email, including the nearest major city, to IBD@Osiris.com. We will contact you about participating sites in your area.

Phase II Results:
Prochymal Crohn's Disease Phase II Clinical Trial DataThis Phase II trial has completed enrollment.The objective of this study was to establish the safety and efficacy of two doses of Prochymal one week apart in patients experiencing moderate-to-severe Crohn’s disease that is refractory to steroids and immune suppression.

Trial Overview
Ten patients were enrolled in the trial. Male and female patients were eligible and must have been between the ages of 18 and 70. Patients must have had moderate-to-severe Crohn’s disease that was refractory to steroids and immune suppression.

Trial Highlights
- Patients in the trial received two doses of Prochymal within 7 days. All patients had moderate to severe Crohn’s disease and were not responding to standard medications (steroids, immunosuppressants, and biologics).
- Every patient evaluated in the trial had a statistically significant reduction in disease severity by day 28, with relatively low doses of Prochymal and a short treatment course.
Improvement was rapid with a reduction in disease severity on day 7.
- There appeared to be a positive correlation between dose and response: Those patients receiving more Prochymal had a better outcome.
- The treatment was well tolerated with no severe adverse events attributed to Prochymal.

Osiris Stem Cell Therapy - I am in the Study!

So I got the good news/bad news that my CT Scan shows an active Crohn's Flare Up. I completed my CDAI workbook and I am in. The study is being held by Osiris. The study is for Prochymal. I am really excited and I believe my first transfusion is next Thursday! Hopefully I see some quick results.

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.
Eligibility
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