Review reveals unproven clinical efficacy of angiogenic gene therapy in myocardial ischemia, highlighting the necessity of randomized placebo-controlled trials.
The current published clinical literature on angiogenic gene therapy for the treatment of myocardial ischemia does not include a single randomized, placebo-controlled trial. Based on current clinical literature, it is an unproven therapy. Successful animal studies combined with published reports of good outcomes in patients enrolled in uncontrolled trials has led to the expectation that angiogenic gene therapy will ultimately become a clinical reality. The next important landmark in the field will be the publication of data showing a favorable effect of angiogenic gene transfer in placebo-controlled, blinded clinical trials.
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H. Kirk Hammond (2001) studied this question.
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