Advances in Manufacturing of the Tissue Engineered Muscle Repair (TEMR) Technology Platform

The need for regenerative medicine is greater now than ever, as medical advancements allow survival of previously fatal conditions or injuries. However, with increased survival rates comes an escalation of tissue morbidity accompanied by permanent functional and aesthetic defects. Advances in tissue engineering have highlighted the potential of regenerative therapeutics to dramatically improve the treatment of these traumatic, genetic or acquired conditions. Even on a national scale, the massive potential impact of widespread regenerative medicine technology implementation has been recognized with the recent founding of the Advanced Regenerative Manufacturing Institute (ARMI); a ManufacturingUSA initiative funded by the Department of Defense, to provide a centralized consortium for development of breakthrough approaches to overcome the current hurdles preventing more efficient clinical translation of tissue engineering/regenerative medicine technologies.
Specifically in the realm of skeletal muscle tissue engineering, our lab has developed a tissue engineered muscle repair (TEMR) system which has shown great promise in preclinical studies, and is rapidly approaching submission of an IND application to support implementation in a “first in man” pilot study with our first generation TEMR technology. However, more widespread clinical application of the TEMR product will require further optimization of the production process, characterization of the various components of the TEMR technology, as well as refinement of the functional evaluation of the final product. To this end, this thesis has focused on improvements to the following:
- Bioreactor design, control and transportation of the engineered product
- Materials Characterization
- In situ assessment of functional recovery following implantation in a biologically relevant skeletal muscle traumatic injury model.