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Technology Overview
Magnelle® (magnetic organelles) contrast agents are magnetic resonance imaging (MRI) beacons that can be incorporated into a variety of cells, allowing for non-invasive tracking of transplanted cells in vivo using standard MRI instruments.

Through statements and guidance documents, the FDA and other governing bodies such as the CIRM and ISSCR are requesting that non-invasive cell tracking be included in IND (investigational new drug) data packages in pre-clinical and human subject clinical trials.1 The Magnelle technology provides researchers and cell therapy developers with the comprehensive data sets they need to satisfy these requests and is the only cell tracking solution developed specifically for use in cell therapies that provides information on both the location and the viability of cells in vivo over time. Alternative options, like passive contrast agents, do not generally enable live cells to be distinguished from dead cells and can create false positive signals.
 
The information provided by incorporating Magnelle cell tracking into your pre-clinical or clinical studies (i.e. Magnelle-powering your cell assets) could dynamically improve how a clinical research team monitors and manages treatment.
 
Overall, Magnelle-powered TM cell therapies enable better assessment of dosing, durability, and fate under MRI of transplanted therapeutic cells while also supplementing regulatory datasets.
 
For more information on Magnelles and how to order them, please visit our Products and Services page.




References:
  1. Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products FDA. 2015. Key Tools and Technology Hurdles in Advancing Stem-Cell Therapies, CIRM. 2013. Guidelines for Stem Cell Research and Clinical Translation, ISSCR 2016.
 
 
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