Prochymal Crohn's Disease Phase II Clinical Trial Data

This 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.

Click here to read more about the Phase II results.