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news.Bioheart has reported final six-month, follow-up patient data from Seismic trial, which shows that MyoCell myoblast clinical cell therapy is a safe and potentially effective alternative treatment to standard medical therapy alone, for improving heart function among patients with previously implanted cardiac devices who are experiencing congestive heart failure.
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On admission to the trial, patients were randomized on a two-to-one ratio into the treatment versus control groups with 26 patients receiving MyoCell therapy and 14 patients in the control group. All patients were experiencing congestive heart failure and were previously fitted with implanted cardiac defibrillators (ICDs) and receiving standard medical therapy.
Final six-month results show that 84% of treated patients experienced improved or unchanged six-minute walking test scores compared to 16% of the control group and 69% of the control group’s results worsened, versus only 16% of the treated group. While 94% of treated patients experienced improved or unchanged New York Heart Association (NYHA) classification compared to 58% of the control group, 42% of the control group’s results worsened, versus only 6% of the treated group.
Patrick Serruys, principal investigator of the trial, said: “The results from the Seismic trial are encouraging. While the study was specifically designed to show safety, the findings also suggest positive trends in clinical benefits when evaluating the treated group versus the control group at six months.”