A Phase I - II Safety Study of Filgrastim (Neupogen) to Improve Left Ventricular Function After Severe Acute Myocardial Infarction

Summary

The objective is to obtain initial information regarding the safety and efficacy of the use of Filgrastim in the setting of acute myocardial infarction. The secondary objectives are to obtain information regarding the mobilization of relevant stem cell progenitor cells by Filgrastim in this setting and to obtain further clinical information that may be helpful in the assessment of safety and efficacy of this drug as utilized. It is a one center, randomized, placebo controlled, dose escalation, blinded study. It will be 2:1 randomization with 9 patients total. Filgrastim 10 mcg/kg/day will be administered SQ for 5 days vs. placebo. Primary endpoint is death /or myocardial rupture or change in left ventricular ejection fraction from baseline to 30 days. 9 pts. have already completed the first phase of the trial using Filgrastim 5 mcg/kg/day.

Timeline

Start

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Primary completion

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Completion

2007-02

Publications

• Ellis SG, Penn MS, Bolwell B, Garcia M, Chacko M, Wang T, Brezina KJ, McConnell G, Topol EJ. Granulocyte colony stimulating factor in patients with large acute myocardial infarction: results of a pilot dose-escalation randomized trial. Am Heart J. 2006 Dec;152(6):1051.e9-14. doi: 10.1016/j.ahj.2006.09.003.

Drugs

Indications