Ever since nephrologist Robert Brenner joined Burlington, MA-based AlloCure in 2010, he’s been eager to find out how the company’s experimental stem-cell treatment for acute kidney injury would perform in people. Last week, he got his first hint of the answer—and it was a positive one.
On Nov. 12, AlloCure presented results from a Phase 1 study of its treatment at Kidney Week 2011, the annual meeting of the American Society of Nephrology, held in Philadelphia. There were 16 patients in the trial, and it was mostly designed to test the safety of the cells, which are found in adult bone marrow. But AlloCure also used the trial as an opportunity to measure efficacy, by comparing how the patients fared after the treatment to so-called historical controls—people who had suffered from acute kidney injury (AKI) in the past but not been given the cell treatment.
The risk of acute kidney injury, also known as AKI or acute renal failure, is particularly high in patients undergoing coronary bypass surgery or heart-valve surgery. All 16 patients in the trial who received AlloCure’s stem cell treatment, called AC607, were undergoing heart surgery and deemed to be at high risk of developing AKI. But only two of them developed AKI, amounting to 12.5 percent of the total patient universe. By contrast, 29.7 percent of the historical controls developed AKI.
AlloCure also looked at length of stay in the hospital, as well as readmission rates. Patients who got AC607 had a mean length-of-stay of 6.5 days, versus the non-treated patients,