Prochymal Crohn's Disease Clinical Trial

This Phase III trial is no longer enrolling patients.
The objective of the study is to establish the safety and durability of Prochymal in patients experiencing moderate-to-severe Crohn’s disease who are refractory to steroids, immunosuppressants, and biologic therapy.

Trial Overview

Male and female patients between the ages of 18 and 70 years were enrolled, and must have had confirmed active Crohn’s disease. Patients must have had non-obstructive ileitis, colitis, or ilecolitis and must have been non-responsive to, or intolerant of, at least one steroid, one immunosuppressant, and one biologic.

For further information or to inquire about possible participation in this trial, send an e-mail to IBD@Osiris.com

Prochymal - Frequently Asked Questions

1. What is Prochymal?
   
2. What does Prochymal do?
   
3. Is Prochymal safe?
4. Can the cells go to other areas of the body?
   
5. What is the treatment in this trial?
   
6. How do I participate?

Q: What is Prochymal?

A: The active ingredient of Prochymal, the investigational therapy in this study, is adult mesenchymal stem cells (MSCs). The cells in this product are from normal healthy adult volunteer donors, and are not derived from a fetus, embryo or animal. Studies have shown that these cells are universally compatible. Similar to Blood Type O, these MSCs may be used without tissue type matching for specific patients. Prochymal is produced in a controlled setting and is tested for possible infectious agents (such as viruses, bacteria, etc) before it is given by infusion into a vein.

Q: What does Prochymal do?

A: Animal studies have shown that MSCs move to damaged areas of your body. The MSCs interact with the immune cells in your body, reducing inflammation and assisting in tissue repair.

Q: Is Prochymal safe?

A: Prochymal is in clinical trials and not yet an approved and marketed therapy. To date, MSCs have been tested in multiple indications in over 1,000 patients and no major safety concerns have been encountered.

Q: Can the cells go to other areas of the body?

A: When MSCs are injected into animals that do not have damaged tissues, the cells return to the bone marrow. If tissue damage is induced, the cells then leave the bone marrow and travel to those damaged tissues. These cells have been studied for different diseases and have been shown to follow inflammatory signals to various areas of the body to aid in repair.

Q: What is the treatment in this trial?

A: Patients who met the study criteria received either Prochymal or a placebo treatment. Neither patients nor patients' physicians know which treatment they received. Participants will undergo tests prior to and at various timepoints after treatment to determine any changes in their Crohn's disease symptoms. In addition to study treatment, patients received standard medical therapies for Crohn's disease.

Q: How do I participate?

A: This trial is closed to enrollment. For more information, please contact us at IBD@Osiris.com.