Manufacturing Cells for Clinical Use
1Kansas State University, Manhattan, USA
2Carpenter Group Consulting Inc., Washington, USA
3Athersys Inc, Cleveland, USA
4Justus Liebig University Giessen, Giessen, Germany
Manufacturing Cells for Clinical Use
Description
Over the past decade, cell therapy has moved forward on multiple fronts. For example, according to one report in 2014, 373 clinical trials worldwide use stem cell therapy (Bersenev Alexey. Cell therapy clinical trials – 2014 report. Cell Trials blog. January 22, 2015. Available: http://celltrials.info/2015/01/22/2014-report/). Most of these trials use mesenchymal stromal cells (116 in 2014, ibid) which require GMP grade manufacturing to produce cells of sufficient number and quality for a clinical product. Similarly, embryonic stem cells (3 trials in 2014, ibid) are in clinical trials. In the near future, induced pluripotent stem cells will provide patient-specific cells for clinical application. There are a number of considerations and regulatory requirements to move cellular therapy into the clinic. The field is rapidly evolving.
We invite reviews and original papers describing the current state of the art and the challenges along with potential solutions to be submitted for consideration in a special issue of Stem Cells International on Cell Manufacturing for Clinical use. Both experimental and applied papers are welcome.
Potential topics include, but are not limited to:
- Manufacturing MSCs for clinical use
- Use of bioreactors or other specialized equipment for cellular manufacturing
- Characterization of cells for clinical use
- Theoretical and applied scale-up of manufacturing processes for cellular therapy
- Special manufacturing considerations such as gene modified cells
- Regulatory considerations