Pittsburgh, PA (PRWEB) April 11, 2013
Celsense, Inc. announced today that the first patient to have transplanted cells imaged by magnetic resonance imaging (MRI) using the company’s Cell Sense technology has been treated at the University of Pittsburgh Cancer Institute (UPCI). The Phase 1 clinical trial was cleared by the US FDA for the purposes of developing information regarding cell migration following administration of live cells.
This application, involving the use of an autologous dendritic cell vaccine to treat colorectal cancer, is the first time the trafficking of a live cell cancer vaccine in patients has been visualized by MRI in the United States. The administration of live cell vaccines is an emerging strategy to treat a variety of cancers.
Investigators believe that the unaided trafficking of dendritic cells to the lymph node is fundamental to the success of this therapeutic strategy. "We are excited that this study is finally moving forward. While this is only the first patient to be imaged in the clinical trial, we expect that data from this study as a whole will lead to improved outcomes for patients receiving live cell vaccines for cancer," said Charlie O'Hanlon, President and CEO of Celsense.
“Where infused therapeutic cells migrate, how many go where, and how long they stay is something about which we have very little data in a clinical setting. To-date there have been few, if any, tools at our disposal to use in obtaining this information in humans,” says cell therapy industry analyst, Lee Buckler, Managing Director of the Cell Therapy Group. “Cell Sense certainly represents one of the first and only cell imaging technologies that has been cleared by a regulatory agency for human use and to that extent it signals a significant step forward in our ability to learn from what it tells us the cells do post-transplant.”
This clinical trial has been funded by an RO1 grant from the National Cancer Institute at the National Institutes of Health. The co-investigators at UPCI are Drs. Pawel Kalinski and David Bartlett. Other investigators include Dr. Eric Ahrens at Carnegie Mellon University and Dr. Amy Wesa at Celsense.
About Colorectal Cancer (CRC)
CRC is the third leading cancer in the United States and the most common form of gastrointestinal malignancy. CRC accounts for approximately 150,000 new cases annually. Immunotherapeutic interventions using live-cell DC vaccines may potentially be effective in CRC patients. To date, the inability to accurately follow the location of the cells after transfer to the patient is one of the critical bottlenecks in the development and delivery of cancer immunotherapies.
About Cell Sense
Cell Sense is a patented fluorocarbon tracer agent used to safely and efficiently label cells ex vivo without the use of transfection agents. Labeled cells are transplanted into the patient enabling researchers and clinicians to non-invasively track the administration and migration of therapeutic and/or diagnostic cells using 19F MRI or MRS. Applications include tracking cells in immunotherapy or regenerative medicine as well as diagnosis of inflammatory sites by tracking selected populations of immune cells. Cell Sense 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. It is expected that in vivo cellular imaging will routinely be used to provide a surrogate biomarker for certain cellular therapeutic and drug trials.
Celsense, Inc. develops and offers novel pre-clinical and clinical-grade products that enable the non-invasive imaging of cells in vivo using MRI. Celsense’s mission is to be the standard for cellular imaging in human health.