Crohn’s Disease

Phase 2 Crohn's Disease Data

Prochymal is currently in clinical trials for the treatment of moderate to severe Crohn's disease, a painful, disabling inflammatory disease that often requires surgery. Osiris is currently conducting a multi-center trial to evaluate the safety and efficacy of Prochymal for Crohn's disease.

In previous studies in gastrointestinal graft versus host disease (GvHD), Prochymal has been shown to reduce inflammation and promote crypt regeneration in the damaged intestine. Below is an endoscopic view and corresponding histology in a patient with severe gastrointestinal GvHD before (left) and nine days following Prochymal treatment (right). At the time of Prochymal infusion, this patient was unresponsive to all other modes of intervention. Nine days after treatment with Prochymal, there is a decrease in intestinal inflammation and ulceration as well as corresponding crypt regeneration as depicted by the arrows.


Prochymal® Phase 2 Crohn’s Disease Clinical Trial Data

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

Trial Design

  • 10 patient, prospective, randomized, open label trial
  • Average CDAI was 350
  • Average length of disease was 14 years
  • Failed previous treatment with steroids, methotrxate, and Remicade

Efficacy Results

  • Every patient evaluated had a reduction in disease severity by day 28
  • 105 point improvement in CDAI (p=0.004)

Safety Results

  • No attributed SAE’s
  • Well tolerated
  • Outpatient administration (20-70 min)

Click here to view the poster presented at the 2006 American College of Gastroenterology Conference.

 

If you have questions about this clinical program, please email us at IBD@Osiris.com


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