Celsense posts new whitepaper providing guidance to IND sponsors
May 1, 2019 – Pittsburgh, Pennsylvania
Celsense, Inc. (Celsense) announced today that it posted a new whitepaper on its website providing customers and potential customers with general guidance on the experimental data required to add MRI cell tracking using Cell Sense CS-1000 (CS-1000) to a cell therapy IND application. The whitepaper, authored by Celsense personnel, describes a series of in vitro experiments where the results are used to demonstrate that CS-1000 labeled cells are pharmacologically equivalent to unlabeled cells. To help investigators plan actual experiments, the whitepaper includes pro forma data sets for different cell types and tissue culture conditions.
“We have worked one-on-one with multiple customers to help them navigate the regulatory requirements to track the administration, migration, and persistence of therapeutic cells in early clinical studies. We recognize that planning to add an MRI tracer agent to product manufacturing process can be daunting. With the general guidance in this whitepaper, we hope we can eliminate much of the mystery regarding the experimental data needed to support a successful IND application,” said Charlie O’Hanlon, the President and CEO at Celsense.
About Cell Sense CS-1000
Cell Sense is a patented fluorocarbon tracer agent used that enables researchers and clinicians to non-invasively track the administration and migration of therapeutic cells using MRI. Cell Sense CS-1000 is the subject of a Drug Master File at US FDA and Health Canada, and is the only clinical grade MRI cell tracking reagent available in North America.
Celsense, Inc. develops and offers novel product that enable the non-invasive imaging of cells in vivo using magnetic resonance imaging (MRI). The company’s lead product Cell Sense CS-1000 is a patented fluorocarbon tracer agent used to safely and efficiently label cells ex vivo without the use of transfection agents. Cell Sense CS-1000 is the subject of a Drug Master File at US FDA and Health Canada, and is the only clinical grade MRI cell tracking reagent available in North America. Using software developed by Celsense, investigators can quantify the number of labeled cells in a user-specified region of interest. Celsense’s mission is to be the standard for cellular imaging in human health.
Charlie O’Hanlon, President and CEO
Real-Time Results,<br />Faster and More Accurate
Celsense offers products that enable real-time MRI detection of inflammation and cellular therapeutics. The mission of the company is to be the standard for cellular imaging in human health.
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