Prochymal Clinical Trial for the Treatment of Chronic Obstructive Pulmonary Disease

This Phase II study has completed patient enrollment.
The objective of this Phase II study is to evaluate the efficacy and safety of Prochymal in patients with moderate to severe chronic obstructive pulmonary disease (COPD). COPD is a form of lung disease characterized by limitation or obstruction of airflow in the airway.  COPD has no known cure, thus current therapeutic intervention is aimed at providing relief of symptoms. The characteristics and biological activity of Prochymal, along with a good safety profile in human trials to date, suggest that Prochymal may be a good candidate for addressing this unmet medical need.

Trial Overview
A total of 62 patients have been enrolled in this trial. Male and female patients were eligible and were between the ages of 40 and 80 years old. Patients must have been diagnosed with moderate or severe COPD and must have been a current or ex-smoker.

If you or someone you know has COPD and would like more information, please contact us at COPD@Osiris.com.

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

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 is 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 received four intravenous infusions of either Prochymal or a placebo once per month for each of four consecutive months. Neither the patient nor the physician is aware of the treatment assigned to a patient.

Q: How long is the trial?

A: The total time commitment for patients enrolled in the study is two years.

Q: How do I participate?

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