Prochymal Clinical Trial for the Treatment of Steroid-Refractory Acute GvHD

This Phase III trial has completed enrollment.
The objective of this Phase III study is to evaluate the efficacy and safety of Prochymal in those patients who are not responding to steroid therapy. It is expected that the stem cells will distribute to areas of inflammation where they can repair the damaged tissue.

Trial Overview
244 patients were enrolled in this trial. Male and female patients between the ages of 6 months and 70 years old were enrolled in this global trial. All patients had a diagnosis of steroid refractory Grade B-D acute GvHD.

Prochymal for GvHD - 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 long is the trial?
   
7. 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. Previous clinical trial data suggest that symptoms of GvHD have improved in many patients receiving MSCs. In these cases, diarrhea was reduced, ulcerated intestinal lining improved, and skin lesions healed.

Q: Is Prochymal safe?

A: MSCs have been tested in multiple indications in over 1,000 patients to date and no unforeseen events have been encountered. Prochymal is currently in clinical trials and not yet an FDA approved and marketed therapy.

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 and decided to participate in this study, received either Prochymal or a placebo twice per week for each of four consecutive weeks. Neither the patient nor the physician is aware of the treatment assigned to a patient. Patients continued to receive standard therapies for GvHD.

Q: How long is the trial?

A: The total time commitment for patients enrolled in the study was 180 days.

Q: How do I participate?

A: This trial is closed to enrollment. For more information about our other GvHD clinical trials, please contact us at Prochymal@Osiris.com