January 30, 2015 | by Nicole White
The lack of a practical way to produce and store enough stem cells for larger-scale therapies and clinical trials is creating a bottleneck in stem cell research. A new grant to City of Hope from the California Institute for Regenerative Medicine (CIRM) will help solve that problem.
The $899,728 grant, awarded Thursday to City of Hope researchers, will enable researchers to adapt current cell culture techniques to a more scalable and controllable system that reflects Good Manufacturing Practices.
Existing cell production methods allow for pluripotent stem cells and progenitor cells, but these methods simply can’t be scaled up, from a practical perspective, to the level necessary for clinical trials and for some of the stem cell products expected to be in high demand. For example, cardiomyocytes – heart muscle cells – derived from stem cells show promise as a treatment for heart failure, which is occurring at epidemic rates. However, large doses of these cells would be required for sufficient therapeutic use, and current production practices don’t support that type of increase.
City of Hope scientists will develop a bag-based bioreactor system for stem cell expansion – a technique already shown to simply, safely and effectively cultivate other types of cells and therapeutic agents. Such bioreactors culture cells in specialized bags that are kept in motion, and have been shown to be superior and more cost-effective in many cases than stirred-tank bioreactors made of glass or stainless steel.
“This addresses an existing need in stem cell research, which has reached the point that projects are stymied by bottlenecks in cell production capacity,” said Larry Couture, Ph.D., senior vice president and founding director of the Sylvia R. & Isador A. Deutch Center for Applied Technology Development at City of Hope. “Success in this project will remove a key barrier to developing many regenerative medicine products, especially those where high human doses are required, such as cardiomyocytes.”
Current stem cell suspension culture systems, first developed at City of Hope, are limited to a few liters of production using spinner culture flasks, while a bag system could increase production to several hundred liters. This would open the door to large clinical trials and commercialization of other regenerative medicine cell products in coming years.
The award came as part of $30 million in Tools and Technology grants awarded by CIRM intended to overcome translational roadblocks to stem cell therapies.
“Sometimes even the most promising therapy can be derailed by a tiny problem,” said Jonathan Thomas, J.D., Ph.D., chair of the CIRM board. “These awards are designed to help find ways to overcome these problems, to bridge the gaps in our knowledge, and ensure that the best research is able to keep progressing and move out of the lab and into clinical trials in patients.”
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