This project aims to develop and commercialize a novel and highly sensitive MRI probe technology for the cell therapy tools market. This project will transfer technology invented in the academic lab of Dr. Ahrens at UCSD, to Celsense, Inc., an established company that offers imaging agents for visualizing the trafficking of cell therapies and inflammation in the body using magnetic resonance imaging (MRI). Overall, the Company?s products are tools that provide quantive data on the in vivo trafficking of cells. The core products of the Company are imaging agents based on unique perfluorocarbon (PFC) emulsion compositions. The Company generates revenue by international sales of its proprietary imaging agent products for clinical and preclinical use, as well as specialized software, licensing fees, and fee-for-service contracts. A common need for developers of cell therapies is a non-invasive means to visualize the biodistribution of cells following injection. Imaging of cell trafficking can provide crucial feedback regarding the persistence, motility, optimal routes of delivery and therapeutic doses. This same information can also help to overcome regulatory barriers. The PFC agents are designed to be taken up by cells in culture, and following transfer to the subject, cells are tracked in vivo using fluorine-19 (19F) MRI. The fluorine inside the cells yields cell-specific images, with no background signal. Images are readily quantified to measure apparent cell numbers at sites of accumulation. We and others have demonstrated that these methods can track a wide range of cell types including various stem cells and immune cell types. Importantly, a collaboration between Celsense and the Ahrens lab has demonstrated clinical use with this technology to detect cellular immunotherapy in cancer patients. Looking forward, improving the sensitivity of 19F cell detection will lower the barriers for using this technology in a wider range of biomedical applications. Recent preclinical results from the Ahrens lab demonstrate dramatically-enhanced sensitivity of fluorine MRI by the invention of a new class of molecules that combine highly fluorinated nanoemulsions with the magnetic properties of metals that are solubilized into the fluorous phase. The resulting 19F MRI detection sensitivity boost is conservatively estimated to be at least 8-fold at a clinical field strength of 3 T. These recent advances in imaging probe technology will fit perfectly into Celsense?s reagent product line. The goal of this project is to initiate this technology transfer and make the transformation to commercial product, initially for the preclinical market.
The Specific Aims of this project are: (1) Chemistry optimization and scale-up; (2) Physical analytical characterization and stability testing of prototype nanoemulsion agent; (3) In vitro biological testing of cell uptake, cytotoxicity and cell phenotype in cells labeled with FETRIS; (4) Generation of in vivo preclinical MRI datasets in rodents for agent evaluation and marketing purposes. Our view is that the new FETRIS imaging probe technology will be attractive to customers due to its greatly enhanced sensitivity and image quality.
This project aims to commercialize a novel reagent technology used to tag and image new types of therapeutic cells, such as stem cells and immune cells, that are delivered to the body to treat life-threatening diseases. The cells are imaged using magnetic resonance imaging (MRI). Imaging the therapeutic cells after they are placed in the body helps scientists and clinicians understand the best way to deliver the cells and how they behave afterwards. This information can be used to help speed the adoption of these new therapies.
