The phase I/II study enrolled 10 patients at UMHS and the Cleveland Clinic Foundation. Patients were seriously ill, with acute renal failure and multiple other illnesses, including sepsis, multiple organ failure, acute respiratory distress syndrome and postoperative complications.
Each patient received up to 24 hours of treatment with the renal tubule assist device. Several patients were taken off the treatment earlier because of reactions such as hypoglycemia or low platelet counts, or because of complications related to their other medical conditions.
The bioartificial kidney includes a cartridge that filters the blood as in traditional kidney dialysis. That cartridge is connected to a renal tubule assist device, which is made of hollow fibers lined with a type of kidney cell called renal proximal tubule cells. These cells are intended to reclaim vital electrolytes, salt, glucose and water, as well as control production of immune system molecules called cytokines, which the body needs to fight infection.
Conventional kidney dialysis machines remove these important components of blood plasma, along with toxic waste products, and cannot provide the cytokine regulation function of living cells. Traditional therapy for patients with acute or chronic renal failure involves dialysis or kidney transplant, both of which have limitations.
Humes and his colleagues began developing this technology a decade ago, identifying the adult progenitor/stem cells and testing the device in animals. Initial testing in animals, published in the journal Nature Biotechnology in April 1999, found the cells in the RAD perform the metabolic and hormonal functions lost in acute renal failure.
Eventually, researchers hope the device can become implantable in patients with chronic renal failure as a long-term replacement for kidney function. More testing is needed before that can become a reality, and any standard use of this therapy is still many years off.
“The long-term goal, if this shows effectiveness in patients with end stage renal disease, is to build a fully implantable device. Our lab is working with engineers at U-M and the Cleveland Clinic to make nanofabricated membranes that can miniaturize the device so it can be implanted and fully replace organ function,” Humes says.
In addition to Humes, U-M study authors were William Weitzel, M.D., assistant professor of Nephrology; Robert Bartlett, M.D., professor of Surgery; and Fresca Swaniker, M.D., assistant professor of Surgery. Other authors were Emil Paganini, M.D., of the Cleveland Clinic, and Jack Luderer, M.D., and Joseph Sobota, M.D., of Nephros Therapeutics.
Text for this article was taken from a a UM press release.