AKI is a relatively common condition and is often associated with serious consequences. Recent epidemiologic assessments indicate that approximately 5 to 7% of all hospitalized patients may develop some degree of AKI. Moreover, when AKI occurs, the complications are potentially catastrophic both from patient and health-economic perspectives. AKI is associated with significantly increased in-hospital morbidity, mortality, and associated costs. While there have been a number of strategies evaluated for the treatment of AKI, no effective therapies are available beyond supportive measures including dialysis. AlloCure's innovative cell therapy, AC607, offers the promise of improving outcomes in patients afflicted with this serious condition.

AlloCure, in partnership with Outcomes Insights, Inc. (Thousand Oaks, California), conducted an epidemiological study of cardiac surgery patients that evaluated different definitions of AKI and determined the risk of death, dialysis, time to kidney recovery, and duration of hospital stay (Griffiths et al, 2011). The study analyzed data from 33,249 patients collected from 53 U.S. hospitals. The study found that patients who developed AKI within 24 hours after surgery were at greater risk of in-hospital death and dialysis (10.3% and 3.5% respectively), than those who developed AKI between 25 – 48 hours after surgery (5.3% and 2.2% respectively). Patients with a 0.5 mg/dL rise (approximately 5% of the total study population) in serum creatinine within 24 hours of surgery had worse outcomes compared to patients with a 0.3 mg/dL rise within the same timeframe (16.0% death and 6.2% dialysis vs. 10.3% death and 3.5% dialysis, respectively).

AlloCure has completed a phase 1, dose escalation clinical trial of AC607 (Doty et al, 2011). Enrolled subjects were scheduled for elective cardiac surgery and were at high risk for developing AKI. The phase 1 clinical trial was designed to evaluate the safety of AC607. Additionally, a preliminary assessment of efficacy was conducted comparing AC607-treated subjects to matched historical controls.

Study results demonstrated that the adverse event profile observed in AC607-treated subjects was consistent with that expected for this subject population and no serious adverse events were attributed to AC607 therapy. Also, AC607-treated subjects appeared to have a decreased incidence of post-operative AKI, decreased hospital readmission rates, and a significant decrease in length of hospital stay, when compared to historical controls.

ACT-AKI is a randomized, double-blind, placebo-controlled, multicenter clinical trial evaluating the safety and efficacy of AC607 in cardiac surgery subjects who have laboratory evidence of post-operative AKI (NCT01602328). AlloCure will enroll approximately 200 cardiac surgery subjects at leading tertiary care centers in the United States.

Doty, J., Affleck, D G., Horne, B D., Muhlestein, J B., Psioda, M., Paragamian, V., Warnock, D.G. A phase 1 trial of human allogeneic mesenchymal stem cells for the prevention of acute kidney injury in cardiac surgery subjects. Abstract. Am Soc Neph Kidney Week. Nov 8-13, 2011. Phil, PA. Abs# 20519.

Griffiths, R I., Gleeson, M L., Paragamian, V., Danese, M D., Brenner, R M. Epidemiology and outcomes of acute kidney injury after cardiac surgery. Abstract. Am Soc Neph Kidney Week. Nov 8-13, 2011. Phil, PA. Abs# 24135.

For more information on AlloCure clinical trials, please send an email to allocure@allocure.com.