It’s not every day that Dr. William Fissell hosts tours of his lab at the Cleveland Clinic.
But one afternoon last month Fissell met with a group whose members had more than a passing interest in his research.
Fissell, a nephrologist who treats patients with kidney disease, has been working to perfect an implantable device that will allow patients to get more dialysis treatments while eliminating the need to be tethered to a machine.
The device is not meant to permanently replace a person’s need for a kidney.
A few weeks ago, three dialysis patients took Fissell up on his offer to drop in to talk about his bioartificial kidney project – bioartificial because it incorporates the use of natural or synthetic material with living tissue as part of a medical device.
Fissell and his lab are working to shrink the concept, called the Renal Assist Device, down to soda-can size, which then could be implanted inside a body cavity or in the soft tissues of the abdominal wall. Patients now must go through a procedure three times a week in which extra water, waste and chemicals are removed from the body through a catheter placed in the abdomen.
As the group gathered around a microscope for a glimpse at a silicon chip, Fissell and one of his postdoctoral lab assistants explained how the chip would be used in a membrane that would replace the kidney’s filter mechanism.
“What would be the integrity of the membrane?” asked Joe Blaha of Strongsville.
A local company is working on how to understand the risk profile of the membrane – how safe and effective it is – and how long it can last, Fissell said.
“The next challenge is to make sure that when they fail, they fail safely,” he said.
The discussion continued like that for more than an hour. Fissell said after the visit that such dialogues are invaluable.
“The more patients I hear from, the better I’ll take the lab values stuff and translate them into something that will let the patient have their life back,” Fissell said.
The device is exciting for dialysis patients like Evan Coaker of North Olmsted, who organized the trip to the Clinic’s Renal Nanotechnology Lab.
A genetic condition called Alport syndrome caused Coaker’s kidney failure in 1988. At first, he went on peritoneal dialysis, which uses the abdominal lining to filter blood. He received a transplant in 1990.
Several years later, the kidney slowly started to lose function. The kidney was removed in 2002, and Coaker resumed dialysis in 2002. Today he is on hemodialysis, in which the blood flows through a special filter, then is returned to the body.
“This [Renal Assist Device] is something that has been in science fiction lore for kidney patients for years – something manufactured and placed in someone’s body,” said Coaker, who is again on the kidney transplant wait list.
Fissell started work on the technology in the late 1990s, not long after graduating from Case Western Reserve University Medical School. He teamed up with Shuvo Roy and Aaron Fleischman, two biomedical engineers from the Clinic.
With two small grants from the National Institutes of Health and money from several other sources, they put together a proposal to submit to the NIH.
Team members from Ohio State University, Connecticut Reserve Technologies Inc. and five other companies and universities were chosen for their expertise in various areas.
By 2007, Roy had submitted an original proposal for the implanted device, which would filter the blood of excess fluid and waste products from the body.
The project is on track for the device to be tested in humans by 2017.
Although the implantable device that Fissell is creating is at least eight years away, the project is likely to yield incremental benefits – even if the final result is never achieved, he said.
“Miniaturized dialysis might not be such a bad thing,” he said. “Each component of the project has legs on its own to be able to be a benefit to real patients in the world.”
Not long ago, Fissell spoke to members of the support group Coaker organized three years ago. Fissell’s wife, nephrologist Dr. Rachel Fissell, is the medical director of the center where Coaker goes for dialysis.
Coaker formed the group so other dialysis patients could share their dialysis experiences and keep each other from avoiding the common mistakes of the newly diagnosed, such as eating too much protein, sodium and potassium.
The group also keeps up with new advances in dialysis and kidney disease treatment.
“The most important thing is that it’s a situation that you can live with,” Coaker said. “Like so many other things, at first it seems daunting.”
While Coaker said he hopes Fissell’s project will be developed soon enough so he can benefit, he also hopes he’ll have a successful kidney transplant before then.
Coaker said Fissell’s research is especially exciting because it takes out the “guilt level” that dialysis patients have of waiting to use someone else’s kidney.
“Here we have a miracle in its own way,” Coaker said. “If not for me, then for many others.”
Nanodialysis is bringing innovative products into the market of hemodialysis based on new nanostructured materials. These products allow direct blood filtration featuring:
Sorption filter pads to improve the blood clearance rate in current hemodialysis systems
Wearable artificial kidney offering direct and continuous blood filtration via a lightweight,
wearable dialysis device featuring a unique clearance of small and middle molecule toxins
The improvement in quality of life is being attained thanks to:
improved blood purification via absorption filtering
improved health condition thanks to continuous treatment
higher mobility and employability
curing of early kidney diseased patients by temporarily treatment
Thanks to the improved continuous and improved clearance, the costs for medical care and drugs can be reduced with €10.000/patient/year.
Nanodialysis is a spin-out of TNO and ICInnovation, www.icinnovation.nl