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ARTICLE | Clinical News

Helical Infusion System: Phase I/II data

December 16, 2013 8:00 AM UTC

The double-blind, placebo-controlled, U.S. Phase I/II TAC-HFT trial in 65 patients with chronic ischemic left ventricular dysfunction due to ischemic cardiomyopathy showed that 200 million autologous culture-expanded mesenchymal stem cells (MSCs) or minimally-processed whole bone marrow mononuclear cells (BMCs) delivered via transendocardial injection with BioCardia's Helical Infusion System each met the primary endpoint by demonstrating no treatment-emergent serious adverse events at day 30. At 12 months, there was 1 major adverse cardiac event (MACE) in the MSC arm, 0 events in the BMC arm and 2 events in the placebo arm. There was 1 death each in the MSC and placebo arms and no incidence of ectopic tissue formation was evident with either active therapy.

On secondary endpoints, MLHF questionnaire scores significantly improved from baseline to 12 months by 6.3 points with MSCs (p=0.02) and by 8.2 points with BMCs (p=0.005). There was no improvement on the endpoint in the placebo arm (p=0.38). At 12 months, mean changes from baseline in 6MWD were 32.6 meters in the MSC arm (p=0.12), 16.9 meters in the BMC arm (p=0.3) and 6.3 meters for placebo (p=0.7). Additionally, NYHA classification improved at 12 months compared to baseline in 35% of patients in the MSC arm, 53% of patients in the BMC arm and 44% of patients in the placebo arm. Furthermore, infarct size as a percentage of left ventricular mass was reduced by 18.9% with MSCs, 7% with BMCs and 5.2% with placebo. There were no significant changes in left ventricular chamber volume or LVEF between treatment groups. The University of Miami co-sponsored the trial with BioCardia. Data were published in the Journal of the American Medical Association and presented at the American Heart Association meeting in Dallas. ...