Reporting Scenario # 4 September 18, 2005. Scenario # 4 Mr Brando is entered on single- arm phase I/II tiral of allogeneic unrelated donor MSCs for the.

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Presentation transcript:

Reporting Scenario # 4 September 18, 2005

Scenario # 4 Mr Brando is entered on single- arm phase I/II tiral of allogeneic unrelated donor MSCs for the treatment of GvHD. Mr Brando is entered on single- arm phase I/II tiral of allogeneic unrelated donor MSCs for the treatment of GvHD. MSCs are manufactured & released by study sponsor using proprietary methods. MSCs are manufactured & released by study sponsor using proprietary methods. The hospital Cell Therapy Lab stores, thaws and issues the cells. The hospital Cell Therapy Lab stores, thaws and issues the cells.

Scenario # 4 Four hrs after infusion of the 3 rd MSC product, the patient has Four hrs after infusion of the 3 rd MSC product, the patient has Temp 39C, hypotension, chills, arthralgias, sever headache. Temp 39C, hypotension, chills, arthralgias, sever headache. This reaction has been observed in patients who receive cells cultured in FBS. This reaction has been observed in patients who receive cells cultured in FBS. You are aware the FBS is part of the proprietary manufacturing process. You are aware the FBS is part of the proprietary manufacturing process. Informed consent (sponsor- prepared) doesn’t mention this side effect. Informed consent (sponsor- prepared) doesn’t mention this side effect.

Scenario # 4 Is this an adverse event? Is this an adverse event? Yes. Yes.

Scenario # 4 If an adverse event, is the event serious? Life-threatening? Unexpected? If an adverse event, is the event serious? Life-threatening? Unexpected? This meets the definition of serious and unexpected AE. This meets the definition of serious and unexpected AE. It was not life-threatening. It was not life-threatening.

Scenario # 4 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? Yes, the laboratory should report the event immediately to the Sponsor. Yes, the laboratory should report the event immediately to the Sponsor. The IND sponsor should report this to the FDA within 15 calendar days. The IND sponsor should report this to the FDA within 15 calendar days.

Scenario # 4 What else should you do? What else should you do? Notify your IRB. Notify your IRB. The sponsor will notify other study participants. The sponsor will notify other study participants. With the sponsor you should: With the sponsor you should: Evaluate this patient for anti-bovine protein antibodies. Evaluate this patient for anti-bovine protein antibodies. Consider monitoring other patients. Consider monitoring other patients. Amend study informed consent to discuss this risk. Amend study informed consent to discuss this risk.