Finalist: Building New Kidneys

Kidney transplantation provides the best clinical outcomes for patients with kidney disease with better survival and quality of life compared to dialysis. Unfortunately, there is a severe shortage of donor kidneys for transplantation. Using multiple patented technologies, Miromatrix is working to bioengineer new kidney grafts that consist of human cells grown in pig extracellular matrix (ECM) scaffolds. Perfusion decellularization removes the native cells from pig kidneys while leaving behind a transplantable scaffold that provides the framework needed to grow a new kidney graft. This matrix is completely free of cells and is therefore well-tolerated in humans, as demonstrated by two commercial products developed through decellularization of pig livers, MIROMESH® (soft tissue reinforcement) and MIRODERM® (advanced wound care), that have been implanted into thousands of patients. Perfusion recellularization is used to grow human cellular tissues within pig ECM scaffolds, creating functional tissue.

Miromatrix' perfusion software drives cells to regenerate kidney structures, including blood vessels and nephrons, in laboratory bioreactors. As an initial step, Miromatrix has developed a process to revascularize kidney grafts with consistent performance in vivo. Revascularized kidney grafts have shown sustained vascular patency on follow-up angiographies in chronic pig transplantation models without evidence of blood clotting. This strategy provides the blood vessels required for future implantation of grafts with kidney cells to restore kidney function. To that end, we developed a method to deliver kidney epithelial cells, collected from donor pig kidneys, to the nephrons and collecting system of decellularized kidney scaffolds. These cells repopulate the pig matrix, grow, and regenerate tubule structures, indicating great potential for functional regeneration. The approach to kidney cell isolation, seeding, and co-culture recellularization is being optimized first using pig kidneys, and will then be translated using discarded human kidneys for eventual human kidney bioengineering.

Submitted by Jeff Ross, Dominique Davidow, Joseph Uzarski, Emily Beck, Emmy Russell, Isaac Bergstrom, Shawn Riesgraf, and Nick Wesche on behalf of Miromatrix Medical Inc.

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