Prochymal™ Clinical Trial for the Treatment of Damaged Myocardium Following an Acute Myocardial Infarction (AMI)

This Phase I study has completed enrollment.
This study was conducted to investigate the treatment of symptoms associated with continued heart damage in patients who have just experienced their first heart attack. The objective of this Phase I study was to demonstrate the safety of the product in the acute myocardial infarction patient, and to evaluate preliminary efficacy data.

Trial Overview

Fifty-three (53) patients were enrolled in the trial. Male and female patients were eligible and must have been between the ages of 21 and 85 and in good overall health. Trial entry occurred within 7 days of suffering from first heart attack.

Trial Highlights

• Administration of PROCHYMAL was found to be well tolerated at all dose levels


• Patients in the PROCHYMAL group were four times less likely to experience an arrhythmic event compared to those receiving placebo (9% vs. 37%, p=0.025)


• Fewer patients experienced clinically significant premature ventricular contractions after receiving PROCHYMAL as compared to placebo across all time points (11% vs. 24%, p less than 0.001)


• PROCHYMAL patients with major "anterior wall" heart attacks had a statistically significant 7.0 point (24%) improvement in ejection fraction at three months and a 7.3 point (25%) improvement at six months over baseline (p less than 0.05), while similar patients receiving placebo did not have significant improvement


• Patients receiving PROCHYMAL had significantly improved lung function as measured by improvement in FEV1 % predicted values (17 point PROCHYMAL vs. 6 point placebo, p less than 0.05)


• Significantly more patients who received PROCHYMAL experienced improvement in their overall condition at six months as compared to those receiving placebo (42% vs. 11%, p=0.027)

Click here to read more about the Phase I results.

If you have questions about this clinical program, please email us at Prochymal@Osiris.com