This Small Business Innovation (SBIR) Phase I project will provide critical advances in the understanding of interactions between mesenchymal stem cells and a novel fibrin microthread suture construct in an effort to overcome significant inefficiencies in the field of cell therapy delivery. This work will develop a novel seeding vessel and associated regimen for highly efficient mesenchymal stem cell loading to be applied to fibrin microthread sutures. Once such a regimen has been developed, resultant devices will be implanted intramuscularly in a rat model to explore cell delivery efficiency and host response to the cell-loaded fibrin microthread device. The resultant cell seeding data will provide insight into the extent to which cell seeding efficiency in vitro may be manipulated by simplistic modifications to common seeding conditions including vessel geometry, cell concentration, and total cell load. The in vivo work will provide critical information describing the biocompatibility of fibrin microthreads, cell delivery efficiency of syringe-mediated compared to fibrin microthread-mediated interventions, and inflammatory/fibrotic potential of these interventions respectively. In turn, the systems developed in this project will be expected to provide a platform for further research of cell therapy performed with discreetly delivered, highly viable, and accurately dosed cell populations.
The broader impact/commercial potential of this project relates not only to the specific indication targeted, Achilles tendon, but more broadly to other connective tissue repairs, other enhanced healing indications, and other cell delivery applications. Once fully realized, the Achilles tendon repair augmentation market alone is projected to be worth $500M annually in the United States. While the suture-like form factor may not be ideal for all applications, several types of open surgeries performed upon poorly healing or non-healing organ systems could readily benefit from cell delivery by this technology. This would include indications such as myocardial infarct repair, neural tissue regeneration in cases of stroke, and cochlear tissue regeneration. The successful commercialization of our project represents a significant step forward in tissue engineering and next generation cell-based medicines, promising to improve both longevity and quality of life for countless people.
