The Kidney Project development timeline is in three phases:
- Phase 1: Proof of concept
- Phase 2: Preclinical and pilot study
- Phase 3: Clinical trial and marketing
Phase 1: Proof of concept
Through initial development in Phase 1 we demonstrated the feasibility of the device components individually. We:
- Fabricated robust silicon membranes and tested them to confirm satisfactory toxin clearance at pressures comparable to blood.
- Assessed the membrane materials for safety and blood compatibility.
- Established a reliable supply of human-derived cells and suitable methods of storage for the bioreactor.
- Conducted experiments to show that the cells in a miniature bioreactor provide biological activity including the ability to reabsorb water and salts, just like in the healthy kidney.
Phase 2: Preclinical and pilot study
We are now in Phase 2 during which our collaborators—engineers, scientists, and doctors from across the United States—will build and test increasingly complex prototypes in stages. The work will involve a combination of:
- Engineering improvements to silicon membranes.
- Bench-top experiments with the combined hemofilter and cell bioreactor.
- Packaging of the device for pre-clinical testing.
Phase 3: Clinical trial and marketing
After laboratory experiments show successful device performance, we will implant the bioartificial kidney in human clinical trials during Phase 3.
Significant engineering work remains, but these are not new bioengineering challenges. The approach to the design of the implanted device is guided by two critical aspects of the planned therapeutic strategy:
- patient self-monitoring and reprogramming of the device for truly independent self care and a return to normal life
- patient and clinician recognition of impending device failure and a minimally invasive approach to renewing or replacing failed components
These challenges are being met by the revolutionary innovations already achieved in medical electronics, biomaterials, and minimally invasive surgery. Together, our team is finding answers to the overwhelming burden of illness faced by patients with renal failure and the financial toll on individuals and the health care system.