Cardiac

Phase 1 Acute Myocardial Infarction (AMI) Data

Click Here for more information about our clinical trial for AMI.

Prochymal is currently being evaluated in clinical trials for the preservation and improvement of cardiac function following an acute myocardial infarction, or heart attack. Prochymal has been demonstrated in animal models to prevent pathologic remodeling or scar formation in the infarcted area of the heart. Both animal and clinical studies have demonstrated Prochymal's potential to return heart function to near normal levels in as few as two months.

Prochymal has been demonstrated in animal models and in humans to improve cardiac function and improve patient outcomes. At the two year evaluation point, patients in the Phase I trial evaluating Prochymal for the treatment of AMI experienced significant improvement in a number of clinical outcomes including a reduction in chest pain events, arrhythmias, and improved ejection fraction.


Prochymal® Phase 1 Acute Myocardial Infarction (AMI) Clinical trial Data

Enrollment for this trial has been completed

The objective of this study was to establish the safety and preliminary efficacy of a single dose of Prochymal administered within ten days of a patient's first AMI.

Trial Overview

Fifty-three patients were were enrolled in the trial. Male and female patients in good overall health were elegible and must have been between the ages of 21 and 85 years. Trial entry occurred up to ten days after patients suffered their first AMI.

Trial Highlights

This study was conducted to investigate the treatment of symptoms associated with heart damage in patients who had just experienced their first heart attack.

Trial Design

  • 53 patient, double-blind, placebo controlled
  • Patients 21-85 years of age experiencing their first heart attack
  • Baseline ejection fraction between 30% and 60%

Efficacy Results at 2 Years

  • Overall Adverse Events
    • Prochymal 8 vs. Placebo 11
  • Arrhythmic Adverse Events
    • Prochymal 11.8% vs. Placebo 47.4% (p=0.006)
  • All-cause hospitalizations
    • Prochymal - 38.2%
    • Placebo - 47.4%

Safety Results

  • No attributed SAE’s
  • Well tolerated
  • Outpatient administration (20-70 min)
  • No signs of adverse immune response or infusional toxicity

Click here to read more about the Phase I results.

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

 

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