Patients undergoing heart surgery have a high risk of experiencing acute kidney injuries, a life-threatening rapid loss of kidney function due to damage.
About 500,000 people in the U.S. each year experience AKIs, also called acute renal failure, with at least 20,000 of those injuries related to complications of heart surgery.
While some patients are able to recover from AKIs on their own, a proportion of patients will never regain full renal function and will require lifelong renal replacement therapy, such as hemodialysis. Once patients are on dialysis, mortality rates dramatically increase.
Salt Lake City-based AlloCure Inc., which was spun out of the University of Utah in 2004, is hoping to have the first cell-based therapy on the market for repairing kidneys damaged as a result of heart surgery complications and other AKIs, said CEO John Wirthlin.
The firm's technology, which was discovered by Christof Westenfelder, a professor of nephrology at the University of Utah, and Axel Zander, a hematologist and the director of the transplant center at the University Hospital Hamburg-Eppendorf, Germany, uses bone marrow-derived stem cells of adult donors to stimulate organ repair, Wirthlin explained.
Because AKI is a serious and complex condition involving a complex organ, there has been little success in developing therapies to reverse the course of the disease, he said.
While dialysis replaces the general function of the kidneys, it does not heal the organs, Wirthlin noted.
The goal of AlloCure's cell-based therapy, he said, is to "stop the continued degradation of the kidney function and then heal the kidney and return that kidney to full function."
AlloCure's therapy, which has shown success in animal models, works by honing in on the damaged kidney and stimulating organ repair, which improves recovery and survival of patients, Wirthlin said.
The cells possess powerful immunomodulatory properties through anti-inflammatory actions and suppression of the T-cell response. AlloCure's cells are immune-privileged, which makes them virtually invisible to the intrinsic immune system.
The cells do not require any blood or tissue matching to the donor, so therefore, the firm can manufacture thousands of doses of the therapy based on donor cells for an "off-the-shelf" product that can be used in any patient much like most typical drug treatments, Wirthlin explained.
"That's why this is so groundbreaking," he declared. "The way that it works is we process and grow up our particular cell, and then we administer those in the ephemeral artery, and these cells are naturally honed to the damage kidney," Wirthlin explained, noting that after a few days, the cells are naturally flushed out of the kidney after completing their job of stimulating organ repair.
AlloCure plans to soon start Phase I testing of its therapy in cardiac surgery patients at high risk of developing AKI, Wirthlin said.
The study will be conducted at Intermountain Medical Center in Salt Lake City, he added.
AlloCure recently raised $14.5 million in a Series A financing to fund its Phase I and II trials of the cell-based therapy over the next three years, Wirthlin noted.
The round was led by SV Life Sciences, joined by Novo AS, the holding company for the Novo Group, a subsidiary of the Novo Nordisk Foundation, of Copenhagen, Denmark.
The company also plans to use the funds for its ongoing research in other areas, Wirthlin added.
"We plan on developing a broad-based platform based on this technology," he said, noting that AKI is just the first target.
Cell-based therapies, Wirthlin said, will be "the next wave in technological development for the health care community" in treating complex medical conditions.
"There's a lot of work going on in cell therapy right now, some exciting work, and it's a very promising and growing field," he said, noting that AlloCure's cell-based therapy will be one of the first to enter clinical trials in AKI.
"We are very excited about the opportunity to give these kidney patients something to help their condition, because up to this point, there really hasn't been anything that doctors can do beyond dialysis," Wirthlin said.