July 02, 2003
Bioartificial Kidneys And Livers Under Development

Technology Review has a good review article on various efforts to use cells grown in mechanical devices to create temporary organ replacements for kidneys, livers,

“Patients who are undergoing chronic dialysis become malnourished, and they sort of wither,” says Harmon. The solution, believes Humes, lies in harnessing kidney cells themselves—cells that can rapidly react to changes in the body’s environment in a way that machines simply can’t.

The kidney-in-a-cartridge, which is being developed by Lincoln, RI-based University of Michigan spinoff Nephros Therapeutics, could be ready for widespread use in as little as three years. And it’s only one example of the increasingly popular strategy of using living cells to do the heavy lifting in artificial organs. Several academic labs are developing similar devices packed with liver cells to chew up the toxins that accumulate in the blood when the liver suddenly fails. Already in human trials, these bioartificial livers could help patients in acute liver failure, whose only chance today is a rare organ transplant.

Nephros Therapeutics, Inc. has received a lot of funding to bring the Renal Assist Device to market.

Nephros Therapeutics, Inc. announced today the successful completion of a Series C financing totaling $17 million to accelerate the clinical development of its lead product, the Renal Assist Device (RAD). Based on patented renal stem cell technology licensed from the University of Michigan and invented by Dr. H. David Humes, Nephros is developing the RAD for the potential treatment of Acute Renal Failure (ARF). Lurie Investments of Chicago, IL led the financing round. New investors participating in this round include CDP Capital of Montreal, QC, as well as Foster & Foster of Greenwich, CT. All of Nephros’ existing investors, including BD Ventures, Portage Venture Partners, North Coast Technology Investors, Palermo Group (an affiliate of the Apjohn Group), and the founding investor, Seaflower Ventures, also participated in this round.

Nephros’ Renal Assist Device (RAD) is a cellular replacement therapy system that leverages the Company’s proprietary Renal Proximal Tubule (RPT) cell technology for the potential treatment of ARF patients. RPT cells play a key role in the regulation of response to inflammation and stress and are critical to normal kidney function and the patient’s ability to fight infection. Nephros has established pioneering technologies to isolate and expand (ex vivo) kidney-derived stem cells and to then create delivery systems. In contrast to the limitations associated with current replacement therapy (e.g. hemodialysis), the RAD’s RPT therapy is being investigated for the potential to replace and maintain a full range of key functions of the kidney, including endocrine equilibrium, metabolic activity and immune surveillance. Nephros is currently supporting two Phase I/II physician-sponsored clinical trials for RAD, at the University of Michigan and the Cleveland Clinic, for the potential treatment of ARF.

David Humes, M.D., Professor of Internal Medicine at the University of Michigan has worked for a decade to develop the bioartificial kidney that is going thru clinical trials.

A bioartificial kidney device invented by Dr. Humes is being clinically evaluated for treatment of patients in acute renal failure. Phase II human trial of the device has been approved by FDA and is expected to commence in the Fall of 2003.

The same core technology using adult kidney stem cells will be soon be tested in a device designed to ameliorate hyperinflammation associated with End Stage Renal Disease. Hyperinflammation may lead to infections and cardiovascular problems, leading causes of early death in chronic renal failure patients.

No volunteers are needed for either of these studies.

Phase I trial recently concluded on the device for treating acute renal failure was led by principal investigator Robert Bartlett and co-investigators William (Rick) Weitzel and Fresca Swaniker in Ann Arbor and by Emil Paganini in Cleveland. The initial study demonstrated that the device is safe for further testing. The next investigations will measure the treatment's effectiveness. Published results, as they become available, will be added to the link at the bottom of this page.

Acute renal failure is a sudden onset of kidney failure brought on by accident or poisoning. Unlike chronic renal failure, acute renal failure is potentially reversible, if the patient can be sustained through the episode. Most cannot. The mortality rate of ARF is greater than 50%.

The poor survivability of ARF appears to be linked to the loss of certain functions of the kidney that reside in cells called renal proximal tubule (RPT) cells. The RAD conceived by Dr. Humes contains living human renal proximal tubule cells. In large animal studies [reported in the journal Nature Biotechnology (April 30 1999)], the Humes lab demonstrated that the cells in the RAD perform the metabolic and hormonal functions lost in ARF. Restoring these critical functions by use of the RAD may be key to helping patients survive acute renal failure.

Because the RAD contains living human tissue it is termed a bioartificial kidney.

Initial trials with patients suffering from acute kidney failure were more successful than expected probably because the bioartifiical kidney cells released chemical messengers that suppressed an immune response that was damaging the kidneys of the patients experiencing kidney failure.

In early clinical trials at the University of Michigan, a bioartificial kidney has been used in a handful of intensive-care patients who were deemed very likely to die because kidneys and other organs were failing. All but one recovered with normal kidney function.

Also see this previous post entitled Device Maintains External Liver Cells For Blood Filtration.

Current purely artificial kidney dialysis machines do only a subset of what a real kidney does and there is a clear need for functionally richer replacement devices. Bioartificial livers and kidneys which use living cells are going to reach the market well before fully functional purely artificial versions of those same organs are ready. In large part this is because we do not know all the functions that livers and kidneys carry out. Best to use cells that know how to do all the functions while scientists try to figure out how those organs work in greater detail.

Complete organs grown to replace diseased organs are also further into the future than bioartificial devices. The tissue engineering problems involved in growing complete organs are also a lot tougher to solve than problems involved in growing cells in artificial apparatuses. My guess is that for more complex organs such as the liver and the kidney the ability to grow replacement organs will be achieved many years before the ability is developed to build a totally artificial organ that carries out all the functions that the real organs do.

Share |      Randall Parker, 2003 July 02 02:21 AM  Biotech Organ Replacement

Sam Rubinstein said at November 13, 2003 8:42 AM:

I am 86 years old and am currently on hemodialysis. I started in 1998 and except for the kidney failure am in reasonably good health. The kidney failure was probably caused by high blood pressure which currently is under control. Please let me know if I should have interest in this new way to fight Kidney failure.

Armine Kazazian said at March 29, 2004 12:24 AM:

Dear Dr.humes
I'm an undergraduated student ,I'm intersted in your research of bioartificial kidney.
I want some help from you ,if you please can give me any information about the materials used & their testing,and about the prototype that you made for the bioartificial kidney

ashima said at May 21, 2004 5:34 AM:


D.S.Kohli said at December 26, 2004 11:35 AM:

Dear Dr. Humes,

Im writing to you all the way from India.

I have been doing some searches on the internet regarding ARF diseases & remidies, unfortunately the only remedy as of now is to undergo Dialysis or go in for a transplant which again is not a 100% chance by itself.

My father is aged 65, He had contracted Pneumonia in December 2003, Which went a little un-noticed to the fact that it was treated as a normal routine viral fever. Some checks were done when the fever didnt subside & it was found out that he had contracted Pneumonia instead which resulted in his Lungs being filled with water. He was put on a rather strong dose of Antibiotics to clear his chest & subside the fever. Unfortunately that episode has left him with a CRF presently. The unfortunate part is that he has only One Kidney which is the kidney in question here & is not working properly. The other Kidney it seems had been shrunk since long back.

He is undergoing Dialysis after every 3-4 days for about 3-4 hours. His creatnine levels are around 8-9 & his Urea is about 170-185. He is a strong will powered individual. He had underwent a ByPass surgery in April 2002 & is all hale & hearty except for his Kidney problem.

My request to you is to advise what remedial should be undertaken to easen his life what follows & also am very keen to find out more about when your artificial kidney would be made available as a transplant to benefit unfortunate people like my father.

Any further information that might be needed, Please do advise.

Best regards & hope the good work done by you & your team would bring smiles into many lives.

Cell: +

Mary Anne Loewe said at March 10, 2005 2:51 PM:

Dear Dr Humes,

I am writing this for my mother. She is 80 years Old this year in 2005.
She was told by a kidney specialist that she has 98% Kidney failure.
She also suffers from high blood pressure.
She refuses to go on dialysis. She has witnessed my brother suffer
through dialysis therapy, to her it is a cruel way to live.

Would someone like her benefit form the new bioartificial kidney,
at such a late stage of the disease?

Carmen Martinez said at July 10, 2005 12:36 PM:

Dear Dr Humes:

I am currently studying with the open university and been asked to write about the advatages and disadvatages of the RAD,i have read that the proximal convoluted cells in RAD are able to produce substances on their own and i would like to ask you which substances are refered to . I am refering my self to the paper in http://www.abe.msstate.edu/classes/abe4513/groupB-2003/Bioartificial.htm

kirron saha said at July 16, 2005 1:40 AM:

cause of high blood pressure i have my left kidney shrunkso can i revive it again? what medicines should use what exercises should i do;i am from india so kindly tell me what n how much i eat THanks

M.SAMPATH KUMAR said at October 3, 2005 1:15 AM:

Dear sir,

Please let me , whether my cousin who is sufferuing from Accute Renal Problem and taking a treatment of Peritonial Dialysis cna have a STEM CELL CULTURE TREATMENT instead of a KIDNEY TRANSPLANT. Currently he is fine, but has Diabites , Cordioric problem. He now developed a pain in the right leg bone.

Any early reply is very much appreciated. If you can kindly suggest Doctor/Surgeon in INDIA it would be verymuch useful and appreciated.


Cynthia Curinton said at October 24, 2005 3:14 PM:


I went in the hospital for a simple 1 day out patient surgery for removal of a left ovarian cyst. I left the hospital 14 days later after having pnumonia, extensive blood loss and in renal failure. I have never had high blood pressure or any kidney disease and the doctors think the renal failure was brought on by my massive blood loss. Currently I go to dialysis 3 days a week and my doctor expects my kidneys to recover but can not give me a tine frame. When I left the hospital my creatin levels were 8 and at my last blood work they were 4.6. I just read your info. on this site and was wondering if this is something that may be able to help me.

Thanks, Cynthia

ROBERT WILKERSON said at November 7, 2005 5:39 PM:


satisch ray hiera said at November 11, 2005 2:02 AM:

Dear Dr Humes

Do you know how long it will take before this technology will be used
in the usa or in netherlands ( europe)

I have a mother who is on dialysis for both kidneys and who has some heart

with kind regards

vijay said at November 14, 2006 4:43 PM:

Dear DR. Humes

IT IS HEARTENING TO NOTE YOUR RESEARCH WHICH EVENTUALLY WILL BENEFIT MILLIONS OF HUMANS FOR WHOM ORGAN TRANSPLANTATION IS THE ONLY ALTERNATIVE. I too write this note with a hope of a recovery. I suffer from a polycystic kidney,inherited from my mother, and am on Peritonial Dialysis for the past one year. MY creatinine level is 15.5 and tne urea levels are between 45 and 50. I FORTUNATELY ENJOY A HEALTHY LIFE AS I am devoid of any other complications.Your advice is sought for a speedy recovery.
Thanks and god bless.

kalyani kosaraju said at March 7, 2007 1:17 PM:

Dear Dr. Humes,

I have been doing some searches on the internet regarding "Congestive heart failure" and "Acute Renal Failure".
This is regarding my father. He is 59 years old. He has the "CHF"(congestive Heart failure) since 1993 and now the pumping rate is 40% as per the last week disgnosis. He also has diabetes since 1989. And he developed Acute Renal failure in 2003. And he is undergoing HemoDialysis every alternate day since then. I have seen the article about your invention of "A bioartificial kidney device" on the net. This really has lit our hopes. I would like to know if this helps my father in any way. I would really appreciate your reply.

Any further information that might be needed, Please do advise.

Best Wishes for you & your team that are striving hard to bring smiles into many lives.

Thank you for your time

Kalyani Kosaraju
Email: kalyanikosaraju@gmail.com
Cell: 703-870-0944

Penny Tiliakos said at June 30, 2008 4:40 AM:

Dear Dr Humes,
Is this Bioarticial Kidney technology available now for american patients?
If yes how long will it take for this technology to be available for renal patients in Australia or Greece?
Thankyou for your time.


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