20 Dec Mesenchymal Stem Cells Did Not Prevent Kidney Injury After Heart Surgery
MedicalResearch.com Interview with:
Madhav Swaminathan, MBBS, MD, FASE, FAHA
Associate Professor with Tenure
Clinical Director, Division of Cardiothoracic Anesthesiology & Critical Care Medicine Department of Anesthesiology
Duke University Health System Durham, NC 27710
Medical Research: What is the background for this study? What are the main findings?
Dr. Swaminathan: The background is the need for salvage therapies for acute kidney injury (AKI,) which is a common complication in hospitalized patients. It is particularly a problem in the postoperative period after cardiac surgery. Preventive strategies have not worked well for decades. Hence the focus on strategies that target kidney recovery. Mesenchymal stem cells have been shown to be useful in enhancing kidney recovery in pre-clinical trials. We therefore hypothesized that administration of human Mesenchymal stem cells (AC607, Allocure Inc, Burlington, MA) to patients with established post-cardiac surgery AKI would result in a shorter time to kidney recovery. We conducted a phase 2, double blinded, placebo controlled, randomized clinical trial to test our hypothesis. Unfortunately we could not confirm the hypothesis and there were no significant differences in time to kidney recovery among patients that received AC607 versus placebo in 156 randomized cardiac surgery subjects.
Medical Research: What should clinicians and patients take away from your report?
Dr. Swaminathan: There may be several reasons that we could not see an effect of MSCs in cardiac surgery acute kidney injury AKI, including issues with delivery to the right location, timing, dosage and etiology of AKI. Furthermore the problem of ongoing insult could confound results. The clinical setting of AKI is complex and a simple salvage strategy is unlikely to show a significant effect.
Medical Research: What recommendations do you have for future research as a result of this study?
Dr. Swaminathan: Further research into dosage, timing and mode of delivery. Also testing in a homogenous subject population may be a better strategy.
A Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of AC607 for the Treatment of Acute Kidney Injury in Cardiac Surgery Subjects