Prochymal Clinical Trial for the Treatment of Newly Diagnosed Acute GvHD

This Phase III trial is currently enrolling patients.
The objective of this Phase III study is to evaluate the efficacy of Prochymal in combination with corticosteroids in subjects experiencing newly diagnosed Grade B-D acute GvHD. It is expected that the stem cells will distribute to areas of inflammation where they can repair the damaged tissue.

Trial Overview

Up to 184 patients will be enrolled in this trial. Male and female patients are eligible and must be between the ages of 18 and 70 years old. Patients must have newly diagnosed Grade B-D acute GvHD secondary to allogeneic hematopoietic stem cell transplant (HSCT) or post donor leukocyte infusion (DLI).

If you have GvHD or know someone who does and would like more information, please contact us at Prochymal@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. How long is the trial?
   
9. What are the risks of participation?
   
10. 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 400 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: If you meet the study criteria and decide to participate in this study, you will receive a total of six infusions of either Prochymal or a placebo.  Four infusions will be administered during the first two weeks (twice weekly), followed by two infusions administered during the next two weeks (once weekly).  Neither you nor your physician will know whether you receive Prochymal or a placebo treatment. You will undergo tests prior to and at various time points after treatment to determine the improvement in GvHD. In addition to Prochymal treatment, you will receive standard therapies for GvHD.

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 the study are not paid for their participation. Some sites may offer compensation for expenses incurred during study visits such as parking vouchers, meal vouchers etc., however, this compensation is not guaranteed.

Q: How long is the trial?

A: The total time commitment for the study is one year. You will visit the research location during set time points during the one year study to assess your level of health.

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: If you (or a family member) have received or will receive a bone marrow transplant and are at risk for GvHD, contact your treating physician. For more information about our GvHD clinical trials, please contact us at Prochymal@Osiris.com