Hot Line Session Results: Heart Failure and innovative approaches
A single dose of mesenchymal stem cells delivered intravenously to patients with chronic non-ischaemic cardiomyopathy resulted in clinically relevant benefits in the "Safety and efficacy of intravenous infusion of ischemia tolerant allogeneic mesenchymal stem cells in patients with non-ischemic cardiomyopathy" study presented in yesterday’s Hot Line session.
‘Virtually all previous studies of stem cell therapy for heart failure have followed the concept that the cells must be injected directly into the heart to trigger new growth,’ said study presenter Javed Butler from Stony Brook University, New York. ‘But if stem cells have anti-inflammatory benefits, direct cardiac delivery may not be necessary.’
The study used ‘ischaemia tolerant’ mesenchymal stem cells (itMSC) donated by healthy volunteers and grown under chronic hypoxic conditions, which are believed to enhance immune modulatory properties. In this single-blind, placebo-controlled, crossover, multicentre study, 20 patients with non-ischaemic cardiomyopathy and left ventricular ejection fraction ≤40% and NYHA class II-III were randomised to receive intravenous itMSC therapy (n=10) or placebo (n=12) for 90 days and then crossed over to the other treatment.
Results at 90 days post itMSC infusion showed there were no major differences in primary safety endpoints of all-cause hospitalisation, and adverse events between the two groups. However, compared to placebo, itMSC therapy resulted in statistically significant improvements in the six-minute walk tests, as well as greater improvements in the Kansas City Cardiomyopathy Questionnaire scores.
‘To our knowledge, this trial represents the first experience with intravenously administered itMSCs in patients with any type of chronic cardiomyopathy,’ said Butler, adding that further studies should explore the efficacy of serial dosing for more sustained immunomodulatory effects.
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