Reporting Scenario # 2 September 18, 2005

Scenario # 2 Mr. Hall, 62 yr old man with acute MI, is to receive autologous mobilized PBSCs delivered via intracoronary catheter 5 days post MI. Mr. Hall, 62 yr old man with acute MI, is to receive autologous mobilized PBSCs delivered via intracoronary catheter 5 days post MI. Clinical Study has 2 arms, patients receive either PBSCs or control (placebo). Clinical Study has 2 arms, patients receive either PBSCs or control (placebo). Investigator is blinded to cell therapy arm. Investigator is blinded to cell therapy arm.

Scenario # 2 Shortly after infusion, the patient suddenly develops ventricular fibrillation, requiring electrical defibrillation. Shortly after infusion, the patient suddenly develops ventricular fibrillation, requiring electrical defibrillation. Normal sinus rhythm is restored. Normal sinus rhythm is restored. Catheter is removed. Catheter is removed. Patient shows frequent ventricular premature beats and runs of ventricular tachycardia (not present before infusion). Patient shows frequent ventricular premature beats and runs of ventricular tachycardia (not present before infusion).

Scenario # 2 Is this an adverse event? Is this an adverse event? Yes. Yes.

Scenario # 2 If an adverse event, is the event serious? Life-threatening? Unexpected? If an adverse event, is the event serious? Life-threatening? Unexpected? This AE meets the FDA & ICH definition of Serious AE. This AE meets the FDA & ICH definition of Serious AE. This AE meets the FDA definition of Life Threatening. This AE meets the FDA definition of Life Threatening.

Scenario # 2 Is the Unexpected? Is the Unexpected? That depends on the information presented in the Investigator Brochure, protocol and/or the informed consent. NOTE: The possibility of this event (acute arrhythmia) should be described in these documents. That depends on the information presented in the Investigator Brochure, protocol and/or the informed consent. NOTE: The possibility of this event (acute arrhythmia) should be described in these documents.

Scenario # 2 Is this reportable to the FDA? If so, how should it be reported? Is this reportable to the FDA? If so, how should it be reported? Since the AE was life- threatening, it should be reported to the FDA by phone or fax within 7 calendar days, written report within 15 calendar days. Since the AE was life- threatening, it should be reported to the FDA by phone or fax within 7 calendar days, written report within 15 calendar days.

Scenario # 2 What else should you do? What else should you do? Report the event to the IRB as per SOP. Report the event to the IRB as per SOP. Investigate for potential causes of ventricular fibrillation: Is it related to the cells? The catheter? The infusion technique? Investigate for potential causes of ventricular fibrillation: Is it related to the cells? The catheter? The infusion technique?