Digital Optical Imaging for Tracking Vascular Gene Expression and Early Diagnosis of Atherosclerosis

Atherosclerotic cardiovascular disease remains the leading cause of mortality in the United States. Gene therapy is a rapidly expanding field with great potential for the treatment of atherosclerotic cardiovascular diseases. Several genes have been shown to be useful for preventing acute thrombosis, blocking post-angioplasty restenosis, and stimulating growth of new blood vessels (angiogenesis). However, precise monitoring of gene expression within targeted atherosclerotic plaques is a challenging task. To date, most investigations about imaging of gene therapy have been primarily focused on non-cardiovascular systems, and no in vivo imaging modalities are currently available for vascular gene therapy. The present invention provides for the digital optical imaging of gene expression from the vasculature, which involves fully applying the prominent advantages of optical imaging technology to vascular gene therapy. These advantages include: 1) portability for bedside or operating room monitoring; 2) lack of exposure to ionizing radiation; 3) relatively low cost; and 4) the ability to directly detect commercially-available imaging markers, such as any biological fluorescent/luminous material used in gene therapies. In addition, using the digital optical imaging system, the invention provides for the examination of the internal elastic lamina (IEL) by detecting the autofluorescence emitted from the fiber component of the vessel wall. This is of important clinical significance for the diagnosis of diseased states in the vessel wall. In particular, the invention provides for three novel optical imaging systems: (a) an intravascular digital optical imaging system; (b) an external, non-invasive optical imaging system; and (c) a minimal invasive percutaneous optical imaging system. All three systems can be used to monitor vascular gene therapy procedures and imaging of the internal elastic lamina of any small-, middle-, and large-sized vessels, including arteries and veins as well as capillaries. Description (Set) Proposed Use (Set) Gene therapy is an exciting frontier in medicine today. Our current knowledge about the biodistribution and/or in vivo pharmacokinetics of gene therapy is incomplete and relies mainly on staining of biopsied or post-mortem tissues. Hence, there exists a need to monitor and detect the location of gene therapeutic agents. Preferably, this need is met with minimal invasive or non-invasive means of optically detecting the gene therapeutic agents. The three novel optical imaging systems developed in the present invention provides a series of useful in vivo imaging tools, to not only track vascular gene expression after administration of vascular gene therapy, but also to detect any early pathological changes of the internal elastic lamina of vasculatures for early diagnosis of atherosclerotic cardiovascular diseases. Such tracking and diagnostic capabilities add value for the payer entities and patient population by helping to increase the effectiveness of vascular gene therapy and maximize patient health Patent (Set) aban WO 02/080756

Inventor(s): Yang, Xiaoming

Type of Offer: Licensing



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