Humes' Research Update: April 2006
University of Michigan Medical
School
Published results and background information can be viewed
through links at the bottom of this page
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Humes' Research Update: April 2006
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Thank you for your interest in the research of David Humes, M.D., Professor of Internal Medicine at the University of Michigan, and staff nephrologist, VA Medical Center, Ann Arbor.
Phase II Clinical Trial Completed
The "bioartificial
kidney" invented by Dr. Humes has successfully completed Phase II evaluation for treatment
of patients in acute renal failure. A press release by RenaMed, Inc (the company commercializing Dr. Humes' discoveries in this area) can be read here.
Patients in the study were suffering acute renal failure and were already receiving hemofiltration therapy to clear their blood of toxins and excess water. Additionally, the treated patients all experienced the loss of at least one other major organ – many had lost several. All were desperately ill.
Phase I of this study 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. Results were published in the journal Kidney International (October 2004).
NO VOLUNTEERS WILL BE NEEDED FOR PHASE III OF THIS STUDY
Following a much larger Phase III trial (pending FDA approval) the device could be available for general use as an adjunct in treating acute renal failure within three years.
Chronic Renal Failure
Can living cells in the RAD alleviate the chronic hyperinflammatory state experienced by patients with chronic end stage renal disease? A separate Phase I-II study will soon commence to examine the effect of using the RAD in-line with dialysis. Patients may experience this state as a run-down feeling, as if they had the flu. Hyperinflammation may lead to infections and cardiovascular problems, leading causes of early death in chronic renal failure patients.
NO VOLUNTEERS WILL BE NEEDED FOR THIS STUDY, EITHER
A Replacement Kidney
Work is also underway on making an implantable filter and combining it with the RAD. Preliminary efforts in rodents are encouraging. We expect that to be a five to ten year development cycle.
About Acute Renal Failure
Acute renal failure is a sudden onset of kidney failure brought on by certain antibiotics, or when blood flow to the kidney is interupted due to accident, or as sometimes happens in the course of surgery. 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. Restoring these critical functions by use of the RAD may be key to helping patients survive acute renal failure. In large animal studies [reported in the journal Nature Biotechnology (April 30 1999)], the Humes lab demonstrated that the cells in the RAD perform metabolic and hormonal kidney functions lost in ARF.
Because the RAD contains living human tissue it is termed a bioartificial kidney.
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Human Trial The bioartificial kidney, attached to a pumping system, lies under a warming blanket in the ICU. Its living cells must be kept at the proper temperature. |
H.
David Humes, MD
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Many patients have asked
to support this research by participating in human trials of experimental devices.
Again, no volunteers are needed at this stage of clinical testing. Similarly,
many have asked to help move this technology forward with financial contributions.
In response, The University of Michigan has established a fund to advance academic
research and teaching of kidney tissue engineering*. For details contact: Medical
Center Alumni and Development Office, 301 E. Liberty, Suite 400, Ann Arbor,
Michigan 48104. If you wish to include a check, make it payable to the University
of Michigan and note on it that it is for the Kidney Tissue Engineering Research
Fund, reference 304441. Inquiries: tcichon@umich.edu.
* Disclosure:
Rights to commercialize these research findings have been licensed to RenaMed Biologics, a private company. Dr.
Humes and The
University of Michigan have financial interests in the company. For information
contact:
University of Michigan Tech Transfer, Wolverine Tower 2071. 3003 South State Street
. Ann Arbor, MI 48109-1280
Relevant publications and presentations.
Slide show on the Development of a Bioartificial Kidney