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.
Subscribe to:
Post Comments (Atom)
3 comments:
Hi, I just heard about your being in the Phase 3 Prochymal study! This is so cool! My son has also been approved and will start in the phase 3 in about 4 weeks, out of Dallas. I bet you guys would be interested in talking with each other! He is 21 and a senior at university.
If you are interested in getting in touch, I can give you contact information.
I so hope that everything goes well for both of you! This is really a miracle happening here.
(Even if someone ends up on placebo.) You are in my thoughts, and prayers.
Hey, nice to find your blog... We have a lot in common. I'll be 21 in a week; I've had Crohn's since I was 16. I'm struggling with Crohn's through college working on my chemical engineering degree. I've failed prednisone, 6MP, Remicade, Humira, and Tysabri so far so I'm one of the lucky Prochymal clinical trial guys, too. Hopefully we don't get the placebo... ;)
sure....I would love to talk to him....Will you shoot him a link to the blog and my email, which is wwwchachi @ gmail.com
Post a Comment