Prochymal Crohn's Disease Clinical Trial

This Phase III trial is currently 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 will be enrolled, and must have confirmed active Crohn’s disease. Patients must have non-obstructive ileitis, colitis, or ilecolitis and must be 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. What does it cost to participate in this study?
   
7. Will I be paid if I decide to join this study?
   
8. What are the risks of participation?
   
9. 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 400 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: If you meet the study criteria and decide to participate, you will receive either Prochymal or a placebo treatment. Neither you nor your physician will know which treatment you receive. You will undergo tests prior to and at various timepoints after treatment to determine any changes in your Crohn's disease symptoms. In addition to study treatment, you will receive standard medical therapies for Crohn's disease.

Q: What does it cost to participate in this study?

A: The study sponsor will pay for the procedures, tests and treatments performed for research purposes. The expense of any procedures, tests or treatments related to your normal medical care would be billed to you or your insurance in the regular way.

Q: Will I be paid if I decide to join this study?

A: People who decide to participate in this study are not paid for their participation. Some sites may offer minor compensation for time lost and expenses incurred during study visits such as parking vouchers, meal vouchers, etc. However, this compensation is not guaranteed.

Q: What are the risks of participation?

A: Any associated risks will be fully explained to participants by the physician before trial entry.

Q: How do I participate?

A: Please send an email, including the nearest major city, to IBD@Osiris.com. We will contact you about participating sites in your area.