|Humes holds the prototype bio-artificial kidney that he hopes will bring life-saving treatment for thousands with kidney disease. The prototype is being evaluated for FDA approval and may enter Phase I of clinical trials before the end of the year. Initially, Humes says, the device would be used outside the body and particularly in critical care units when life-threatening renal failure occurs. The prototype filters waste through human cells and returns to the body what it can still use. Current dialysis therapy cannot filter well enough to return anything to the bloodstream. Photo by Bob Kalmbach|
The kidney is the first human organ for which a mechanical substitutethe kidney dialysis machinewas designed, says H. David Humes, the John G. Searle Professor of Internal Medicine. We believe it also will be the first organ to have a fully functioning, implantable substitute created with the new science of tissue engineering.
Humes and his research team recently completed animal testing of a key component of the bio-artificial kidney, called a Renal Tubule Assist Device. This device is designed for use outside the body to treat acute kidney failure.
Each year in the United States, about 190,000 people face this life-threatening condition, in which the kidneys suddenly shut down as a result of infection or injury.
Individuals with acute renal failure typically spend at least 10 days in intensive care attached to a hemo-filtration unit, which removes toxic waste products from their blood. But even with advanced medical care, more than 50 percent of these patients die before their kidneys can recover.
In a study published in the May 1999 issue of NatureBiotechnology, Humes describes how the Renal Tubule Assist Device, connected to a standard hemofiltration unit, helped improve kidney function in laboratory animals with acute renal failure.
According to Humes, kidney cells lining hollow fibers in the device reabsorb vital electrolytes, water and glucose filtered out of blood during hemofiltration, in addition to producing other important molecules. Without these substances, the patient cannot fight off infections and maintain a normal fluid balance.
Pending FDA approval, human clinical trials for the Renal Tubule Assist Device in patients with acute kidney failure could begin as early as this fall. Within five years, Humes hopes to develop additional components of the bio-artificial kidney for patients with chronic renal failurea gradual deterioration of kidney function that currently affects over 300,000 people in the United States, a number that is growing by about six percent each year.
People with chronic kidney failure undergo kidney dialysis treatment several times each week to remove toxic waste products from their blood. The procedure is expensive and has serious side effects.
Our goal is to bring all the components for a bio-artificial kidney together in one implantable device that will carry out all the functions of a natural kidney, Humes says. We hope that one day it will be available as an universal-donor organ. This could eliminate the shortage of kidneys for transplant, end long waiting times for transplant organs and replace dialysis as a treatment for chronic renal failure.
Research on the bio-artificial kidney is being conducted at the Ann Arbor Veterans Administration (VA) Medical Center. Funding is provided by the National Institutes of Health, the VA Research Service and Nephros Therapeutics Inc., a private company established to develop U-M research on kidney tissue engineering into commercial products. Nephros holds exclusive licensing rights to develop the technology; and the U-M has applied for several patents. The U-M, Nephros and Humes hold a financial interest in this new technology.