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Research at Vanderbilt

Project seeks to create ‘bioartificial’ kidney

by | Posted on Thursday, Jul. 11, 2013 — 9:01 AM

William Fissell IV, M.D., holds up a silicon nanotechnology chip, a crucial component in his effort to create an implantable bioartificial kidney. (photo by John Russell)

Nephrologist William Fissell IV, M.D., associate professor of Medicine and Biomedical Engineering, is intent on creating and mass-producing an implantable bioartificial kidney that can transform quality of life and prospects for survival for people with chronic kidney disease who would otherwise be forced onto dialysis.

Donor kidneys are in very short supply for the approximately 600,000 Americans who have end-stage renal disease. Only 50 percent of dialysis patients are still alive three years after the start of therapy for kidney disease, compared with 91 percent survival at three years for those who instead receive a preemptive kidney transplant.

Dialysis costs $80,000 per patient per year, and the total U.S. cost for treatment of end-stage renal disease is upward of $40 billion.

Vanderbilt and the University of California at San Francisco are the lead institutions for development of the bioartificial kidney. Fissell, who relocated from the Cleveland Clinic to Vanderbilt last August, has invested years of groundwork in the device, in collaboration with bioengineer Shuvo Roy, Ph.D., of UCSF, and other far-flung researchers.

Fissell estimates the project has garnered $7 million in funding to date from the National Institutes of Health (NIH) and private benefactors. Last year the project received a significant boost when the Food and Drug Administration selected it for a new fast-track approval program.

Fissell had kidney troubles as a child, from which he has recovered. When he worked as an emergency medical technician (during an extended break from college) he got to know many patients on dialysis.

As he was studying for his medical boards, Fissell found himself contemplating the miniscule structure of the glomerular slit diaphragm, the filter that is broken in chronic kidney disease. His mind suddenly cast back to work he had done as an MIT undergrad in physics and electrical engineering.

“I had this epiphany, as it were. I said to myself, ‘I’ve seen something like that before; in fact I’ve made something like that before.’”

At MIT Fissell had worked in a lab that was developing a piece of technology called an X-ray diffraction grating, used by astronomers to analyze the atomic constituency of stars.

“I saw that the very structures destroyed in most chronic kidney disease had the same approximate size and shape as these devices I had been involved in making and testing as an undergraduate. That’s what started the journey: could we bring these tools from electrical engineering to bear to assist a population of patients that had immense unmet need?”

Vanderbilt and the University of California at San Francisco are the lead insitutions working to develop the implantable bioartificial kidney.

Fissell is still struck by the next coincidence in this story. Even before completing his residency at Case Western, he met Shuvo Roy, who was already making similar nanostructures for a drug delivery application. They’ve been pursuing the bioartificial kidney ever since.

Using silicon nanotechnology similar to computer microprocessor technology, the bioartificial kidney marries nano filters made of silicon with living human kidney cells cultured in the lab from samples harvested from deceased donors. The donated cells form a membrane positioned downstream from the device’s intake filter, out of reach of the body’s immune response, so rejection is not an issue. The device will run on the body’s normal blood pressure, with no other power source required.

Beyond filtering waste from the blood, the bioartificial kidney will also perform other vital functions of the kidney, including maintenance of blood pressure and pH levels and vitamin synthesis.

In clinical research conducted at the University of Michigan, intensive care patients with kidney failure were greatly helped by an externally deployed, large-scale version of the device, developed by H. David Humes, M.D., with whom Fissell trained. The challenge now is to stuff this successful new technology into a mass-producible package the size of a bar of soap.

“Phase one, the proof of concept stuff, all of that is done. Phase two is the difficult task of scaling up the prototype devices to clinical function. We can make one or two at a time, but can we make four million that all work exactly the same? And how long can we make the cells last? How often will you have to come back to the clinic for a replace/renew/refresh cycle?”

Preclinical testing is ongoing and Fissell hopes to begin testing an implantable device in humans in 2017.

“My professional identity is that I’m the nephrologist who’s trying to make an implantable artificial kidney. I’m pursuing this approach because I think it’s not susceptible to some of the vulnerabilities of other approaches. If someone else succeeds meanwhile with another strategy, God bless.

“I’d love it if someone put us out of business. I’ll be the first person to cheer.”

Contact:
Paul Govern, (615) 343-9654
paul.govern@Vanderbilt.Edu


  • Tina French

    I was very hopeful when I read this article, although a little deflated when I saw it would be 2017 before this might be available for use in humans. Having many members affected/deceased by ADPKD I am constantly on the lookout for alternatives to dialysis or even better yet a cure. I appreciate the value of VADs for heart failure patients, yet there is nothing comparable for patients with renal failure. PD and HD are restrictive and typically have a negative impact on ones quality of life.
    I do know someone who would like to enroll in your clinical trial when you reach that point…if he can hang on that long.
    Thank you for your passion in this work!

  • picnicfun

    Go for it and make it happen!

  • Eileen Boyce Cowling

    If you need a trial person, my 24 yr old daughter would be very interested. She started dialysis in 2/2012, and her transplant was removed 5/2012. Her original transplant was in 2006, lasted 6 years. It was only a 3 pt match out of 6.

  • Terry Blythe FederalGrove

    This is very exciting news! I have 2 sons that have Polycystic Kidney Disease. They both have had living donor transplants there at Vanderbilt. My late husband also had this disease and so did his father. They both are doing great with their transplants but we know any day that that could change, I have 4 grandchildren that may also have this horrible disease so this is very exciting and promising news to us.
    Thanks for your endless time and energy that you have put into this life changing implantable artificial kidney. If my family can do anything to further this project please let us know.
    Sincerely,
    Terry Blythe
    Federal Grove
    475 East Main Street
    Auburn, Ky . 42206
    270 542 6106

  • Terry Hopkins

    Happy To Hear Of The Progress Being Made In The Kidney Program ! I Was Diagnosed With ESRD In Jan. ’09 & Have Been On Peritoneal Dialysis At Home For The Past Two Years . Keep Up The Great Work & God Bless You & Your Entire Team !

  • Fawzy Bebawy

    great discovery

  • Nancy Kephart

    You keep that vision and you will have a huge number of people who will benefit from your work. Those with kidney failure need another option other than dialysis and transplant, please keep working on this!

  • Lisa VanValkenburg

    You all are a God send! I hope the time flies until it’s time for human trials. I have spoken with my husband about this and he is excited. He started dialysis late 2012, and is already jaded. Please, please keep up your wonderful work so my husband and many thousands of people can be free to live more normal healthy lives. Thank you so very much for all you are doing.

  • Mary

    Thank you for trying to make this kidney. You give me hope! I am looking at having a third kidney transplant. I have had two and both have failed. I am 39 years old, so not as young as many but younger than most with this disease, and as far as I’m concerned, everybody is too young for dialysis! Anyway, I am very sensitized, so it will be difficult for me to find a transplant, and everyday I consider giving up. So thanks!

  • Tinku

    your success is eagerly awaited. Millions of lives will be blessed from
    ur endeavour. thanks a ton.

  • akash more

    but when u r launching this precious thing plz plz publish the date of launching

  • Earl Eckert

    Is the device suitable for 3D printer production?

  • Earl Eckert

    Is the device suitable for 3D printer production?

  • Roger Mims

    We attend Vanderbilt for a lot. My husband was asked to go to Vanderbilt East Clinic for nocturnal dialysis, with Dr. Rachel Fissel. I pray for this to be used sooner, we are awaiting a transplant. I hope our Dr.Fissel is a part of this, we love Vanderbilt. Praying for your success!!!

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