On World Kidney Day, March 14, 2013, The Kidney Project hosted a live chat on Facebook with the project's directors: Dr. Shuvo Roy & Dr. William Fissell. Here is an excerpt of the conversation about the implantable, bioartificial kidney under development at the University of California, San Francisco.

1. The Kidney Project
Excerpt of Live Facebook Chat with
Dr. Shuvo Roy & Dr. William Fissell
March 14, 2013
9am PST
Facebook.com/ArtificialKidney

2. The following slides are an excerpt of the live conversation
held on Facebook with the directors of The Kidney Project, a
national research project to create a small, surgically
implanted, bioartificial kidney to treat end stage renal disease
(ESRD).
William Fissell, MD, Medical Director & Shuvo Roy, PhD, Technical Director
We hope that the information shared in these slides is informative. Please be aware that nothing said is a
substitute for appropriate professional medical treatment or diagnosis. Always seek the advice of your
physician or other qualified health provider with any questions you may have regarding a medical condition.
Never disregard professional medical advice or delay in seeking it because of something you have read on
this chat. Except where explicitly stated otherwise, it is not intended as specific medical advice. Nothing said
in this chat is an official position of UCSF or Vanderbilt University.

3. What are the guidelines to become a candidate? Will there be
an age limit?
William Fissell That is probably the number one question we get! We hope that
there will be no barriers to candidacy. The limits on transplant today are (1) supply
of organs, which we address by manufacturing the artificial kidney, (2) risk of
immunosuppression (cancer, infection), which we address by eliminating
immunosuppression, and then finally (3) risk of surgery itself, which we address in
the same way we address risk of any surgery for a kidney patient.
In choosing your first group of people for clinical trials, will it be
based on need? Or first come first served?
William Fissell For the first studies, we are focused on safety, and we don't
want to over-promise what it will provide - so need won't play a big role.

4. Do you have a demo to show how the bioartificial kidney
works?

5. How long do clinical trials usually take before Medicare will
approve the treatment?
William Fissell We are not sure, but The Kidney Project was one of three
programs chosen by FDA for inclusion in their "Innovation Pathways" project,
designed by FDA to streamline and simplify the regulatory process.
How long are the cells able to last in the bioreactor before they
need replacement?
William Fissell We know a fair amount about cell lifetime from David Humes'
pioneering work on the RAD, where cells survived for many months in cell culture
without loss of function. In practice, we know patients are different. Every dialysis
unit has a few patients who get one fistula that lasts forever, a few patients who
wrestle with incessant access problems, and most patients are in the middle
somewhere. The same will be true of the bioartificial kidney- we target YEARS of life
before replacement, and we'll have to see how that plays out.

6. Will all insurance carriers pay for the bioartificial kidney or will it
be deemed experimental here in the USA?
Shuvo Roy In the US, Medicare covers the cost of ESRD treatment. So after our
device passes clinical trials, we anticipate that Medicare will cover the bioartificial
kidney as well, and private insurers will follow suit.
How successful is the transplant? If done, how long would it
last?
Shuvo Roy While the device is designed to be a permanent implant, it is possible
that certain components will need to be replaced. The internal components could be
exchanged (filter) or refreshed (cells) via minimally invasive surgical techniques
when such a situation arises.

7. What medications would be required after transplant of the
device?
William Fissell This is a crucial question. First, this isn't a transplant, it's a
medical device. We do not expect any immunosuppression. The cells in the
bioreactor are protected from the patient's immune system by the device itself. We
also don't expect as "much" function as a native kidney or a transplant, so some
blood pressure medicines, erythropoesis stimulating agents, and maybe some phos
binders might be needed.
Do you see this device being a replacement for transplantation
or will there be risks equivalent to immunosuppression?
William Fissell GREAT question. The bioartificial kidney, at least at first, won't
provide all the functions of a "real" kidney, such as blood pressure regulation
through the renin-angiotensin system, or epo production. It probably won't, at first,
provide as "much" function as a "real" kidney - so for now, if you are so fortunate as
to get an "offer" - transplant is the absolute best treatment for end-stage renal
disease.

8. Can you use only the bioreactor for CKD and dialysis patients?
Since kidney disease can progress due to the inability to
control hypertension, is it possible to test the bioreactor for use
with stage 2 or stage 3 patients?
William Fissell Great comment! We obviously would love to be able to prevent
progression, but we don't see a clear path to using the bioreactor alone for that
purpose. Sadly, there's very little evidence that starting treatment with dialysis
earlier does anything to preserve renal function.
What challenges are you working on?
Shuvo Roy We are currently working to build more prototypes for testing, and
evaluate them for their performance. It is an iterative process, but necessary to
ensure we arrive at a functional device that will be safe for patients.

9. Please tell us how can we help to get the artificial kidney closer
to reality and clinical studies? Fundraising? Kickstarter?
Shuvo Roy Thanks for offering to help. There are two main ways: raising
awareness and donations by sharing our website, FB page, publicizing our efforts in
the press, organizing fundraisers in the community, writing to your congressional
representatives, and recruiting celebrity spokespersons, etc.
What advice can you provide to potential recipients as we have
conversations about the artificial kidney with our local
nephrologists? Is there any "clinical pathway" or other protocol
to be followed now in order to be considered later?
William Fissell It's very early to say, but we imagine that the process at first will
work a little like the transplant process works now: patients will be referred by their
nephrologist to a speciality center. there, some operative risk stratification (is it even
safe to think about this?), then, hopefully, the operation and some post-op
monitoring, and then the patient goes back to their original nephrologist for all their
care.

10. I have read you are working on this project with several
American centres. Is there any research aide on the Canadian
side of the border on this project?
William Fissell We are in close communication with several leading centers in
Canada, and The Kidney Project is the Plenary Talk at the Canadian Society of
Nephrology meeting in Montreal in April.
Are there other groups working on artificial kidneys as well?
Shuvo Roy A few groups are working on next-generation renal replacement
devices, including wearable and portable dialysis machines. There are some efforts
on "growing" kidneys, but these are still in the early concept stage. To our
knowledge, we are the only group working on an implantable device that will provide
kidney replacement beyond dialysis.

11. Thank you!
You can see the whole conversation
about the bioartificial kidney on our
Facebook page.
Questions? Comments? Get in touch.
Facebook.com/ArtificialKidney
@KidneyProject #AskTKP
sara.getz@ucsf.edu
kidney.ucsf.edu