Innovative Dialysis Incubator
“I understand why I need dialysis, but how can something that makes me feel so terrible not be hurting me?”
-dialysis patient -
Hemodialysis (HD) is the dominant form of kidney dialysis used in Canada and around the world. It provides effective management of the uremic state. However, HD is associated with very high rates of cardiovascular mortality and poor health-related quality of life. We desperately need improved therapies that can be rapidly translated into clinical care.
Innovative Dialysis Incubator
The current proposal is for the establishment of a clinical research area dedicated to the study of advanced new forms of treatment, for dialysis patients, and sited within the current footprint of the Kidney Clinical Research Unit (KCRU). This facility would be the only one of its kind in the world, permitting intensive cutting edge assessment of newly developing therapies for dialysis patients.
What kind of groundbreaking new research would Innovative Dialysis Incubator enable?
There is already an established active program of cutting edge therapies for dialysis patients under development within KCRU. This list contains innovations invented within London or being developed with external academic or commercial partners. Current examples include:-
Wearable artificial kidney (WAK). This is an in house development of a wearable dialysis system. All preclinical trials are complete and approvals for first in man testing are in place.
Leukocyte Modulatory Device (LMOD). We have developed a method to capture and deactivate inflamed white blood cells. We have already successfully performed world‘s first treatments with the LMOD (for the treatment of severe COVI9-19) but this therapy holds considerable promise in the treatment of people needing long-term dialysis by helping to protect critical organs such as the heart and brain from the effects of conventional dialysis.
Direct sodium removal (DSR). Patients on dialysis are unable to clear salt out of their bodies. We are world leaders in the imaging of salt (using a dedicated type of MRI scanner) and identifying the harms occurring from storage in the body. DSR is a treatment using a fully implanted invisible system; to take extra salt out through the lining of the abdomen and deliver it into the bladder to be passed like urine later. This has been developed with Yale University and commercial partners based in Belgium. We have all permissions in place to treat the world’s first dialysis patient in this way.
Mobius implant. We are leading the application of a new kind of arterial implant to increase the ability of dialysis patients to tolerate removal of fluid (in partnership with a US company). This commonly makes patients feel terrible and results in damage to the heart and brain by starving them of blood supply during the dialysis treatment session. World first patient is planned to be treated at LHSC.
Intradialytic exercise to prevent HD-associated cardiac injury. We are working in collaboration with colleagues across Canada to deliver a RCT addressing this issue (recently secured full CIHR). KCRU will provide patients and act as the core lab for all of the intradialytic echocardiograms from the entire study cohort.
What could we do that we can’t do already?
All of the above examples require very intensive study, therapies which are complex to operate (in development), utilizing multiple physiological monitoring devices and attended by multiple members of the team on each study visit. This is very challenging to perform within busy clinical units, and the environment and footprint is entirely inadequate for these purposes. The IDI would provide a step change in our capabilities, massively accelerating research process and shortening the time to translation of therapies into hospital practice. IDI would significantly reduce barriers to patient participation by providing flexibility of session scheduling improved environment promoting privacy and dignity and reducing potential exposure to viral transmission in busy open unit (during pandemic conditions). Around half of the LHSC Renal Program patients dialyze in satellite facilities, not situated within London. These patients belong to our program but are systematically excluded from our research program opportunities, as we are unable to offer them temporary treatment in current constrained clinical capacity.
Entirely space and cost neutral
We have already identified 600 sq/ft of space within current KCRU footprint (repurposed from office/storage space) to provide dedicated clinical area and associated workshop facilities. Modest modifications are required. These principally include installation of a sink, water supply, power and drainage for the dialysis machines- which would allow the centralized research team to deal with up to 4 patients simultaneously. This proposal is entirely space neutral and funds to cover substantive changes are already in place. We have already sourced all ancillary items (e.g. dialysis chairs, machine, water treatment equipment etc.). All appropriate human resources to deliver therapies and maintain equipment are already in place, and we already routinely deliver research based dialysis therapies outside of the VH/UH dialysis units within LHSC, SJF and Robarts locations (appropriate SOPs and risk management approvals are already in place).
An enhanced ability to rapidly and effectively tackle the scope of research work initially laid out opens up considerable diversified funding opportunities to help KCRU retain and expand its current capacity. We have already secured undertakings (pending the ability to deliver the work streams) for $2m of support for the example activity outlined above (which is only part of our current pipeline) from competitive grant funding (CIHR), commercial partnerships (Sequana Medical, Vascular Dynamics), leveraged federal funds (MITACS) and directed charitable contributions (LHSC and SJH Foundations).
The rapid establishment of the Innovative Dialysis Incubator will provide critically important momentum and capacity to pursue a world class program of novel disruptive therapies to transform the lives of patients living with kidney disease in London, Canada and across the globe.