Timeline

Beginnings

Dr. Fissell was awarded undergraduate degrees in Physics and Electrical Engineering from M.I.T. in 1992. While an undergraduate, he conducted research in X-ray spectroscopy at M.I.T.’s McNair Center for Space Research under the supervision of Claude Canizares. One project developed an X-ray transmission grating spectrometer, which is now in orbit on NASA’s Chandra Observatory. The X-ray transmission gratings are arrays of gold bars one tenth of one millionth of a meter apart, made using silicon nanotechnology.

Later, when Fissell was a medical resident studying for his board exams, he noticed that the filtration structures in the kidney, called podocyte foot processes, had an uncanny resemblance to the transmission gratings he had worked to develop a decade earlier. This was the “lightbulb moment” that started The Kidney Project. Fissell wondered if using a new technology to make membranes that had pores shaped like the pores in the kidney itself could make a better treatment for patients with kidney failure.

Fissell teamed with visionary biomedical engineers at Cleveland Clinic, Shuvo Roy and Aaron Fleischman to prototype experimental membranes using the novel tools of microelectromechanical systems. At the same time, Dr. Fissell completed a nephrology fellowship at University of Michigan with Dr. H. David Humes, the inventor of a large-scale bioartificial kidney, the Renal Assist Device (RAD). During his fellowship, Dr. Fissell conducted preclinical testing of the RAD at university of Michigan.The team demonstrated the basic feasibility of both components of the bioartificial kidney: the hemofilter and the cell bioreactor. The first component filters blood using silicon membranes. The second component is a supply of human cells that can reabsorb water and salts, just like a healthy kidney.

Going Forward

The second phase of the project began in 2011 as the team sought to refine the engineering of the device components. In this phase, the parts of the bioartificial kidney are being tested for safety before being tested pre-clinically.

In 2014, the team refined their surgical procedure so that they are now able to implant test polycarbonate cartridges in animals for up to one month with no evidence of blood clotting.

In 2013, the FDA selected The Kidney Project to pilot a new regulatory approval program called Innovation Pathway 2.0. It is intended to bring breakthrough biomedical technologies to patients more quickly and more efficiently. The Kidney Project was then selected (2015) as the first participant in the FDA’s Expedited Access Program.

Beginning in 2017, the team will work with industry partners to conduct clinical trials and market the device. Candidates for clinical trials will likely be patients that have high levels of antibodies and have been waiting on a transplant for a long time. Dr. Fissell and Dr. Roy hope to market the artificial kidney to patients beginning in 2020.