Prochymal Clinical Trial for the Treatment of Damaged Myocardium Following an Acute Myocardial Infarction

This Phase II study is currently enrolling patients.
The objective of this Phase II study is to evaluate the safety and efficacy of Prochymal for the treatment of symptoms associated with continued heart damage in patients who have just experienced their first acute myocardial infarction (AMI) or heart attack.

This year alone, more than half a million Americans will experience their first heart attack. According to the American Heart Association, within six years of a recognized heart attack, 18% of men and 35% of women will have another heart attack. It is critical that we find new and effective ways to treat the thousands of people who enter hospital emergency rooms suffering from a heart attack.

Click here to read more about the Phase I results.

Trial Overview

Approximately 220 patients will be enrolled in this trial. Male and female patients are eligible and must be between the ages of 21 and 85 years old. Also, patients must have experienced a first myocardial infarction within 7 days prior to trial entry and have a baseline ejection fraction between 30 and 45%.

If you or someone you know has recently experienced a heart attack and would like more information, please contact us at AMI@Osiris.com.

Prochymal for AMI - 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 the body, reducing inflammation and assisting in tissue repair. The characteristics and biologic activity of Prochymal, along with a good safety profile in human trials to date, suggest that Prochymal may be a good candidate for treating acute myocardial infarction.

Q: Is Prochymal safe?

A: Prochymal has 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: If you meet the study criteria and decide to participate, you will receive one intravenous infusion of either Prochymal or a placebo within 7 days following your acute myocardial infarction. Neither you nor your physician will know whether you receive Prochymal or a placebo treatment. In addition to treatment with the study drug, you will continue to receive standard therapies for acute myocardial infarction.

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 two years. You will visit the research location at set points during the two 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: For more information about our AMI clinical trials, please contact us at AMI@Osiris.com