A clinical trial has suggested MyoCell myoblast clinical cell therapy is a safe and potentially effective alternative treatment to standard medical therapy alone for improving heart function.
The final six-month, follow-up patient data was presented during the late-breaking clinical trial sessions at the American College of Cardiology and studied patients with previously implanted cardiac devices who are experiencing congestive heart failure.
The findings from the SEISMIC Trial, a 40-patient, randomised, multicenter, controlled Phase II-a study conducted in Europe, evaluated MyoCell myoblast clinical cell therapy delivered via the MyoCath, endoventricular needle-injection catheter in patients previously fitted with implanted cardiac defibrillators.
The trialist were receiving standard medical therapy and experiencing congestive heart failure.
On admission to the trial, patients were randomised 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 ICDs and receiving standard medical therapy.
Both the MyoCell biologic therapy and the MyoCath needle-injection catheter, developed by Bioheart Inc, are currently being studied as investigational products.
Final six-month results found 84 of treated patients experienced improved or unchanged six-minute walking test scores compared to 16% of the control group and 94% of treated patients experienced improved or unchanged NYHA classification compared to 58% of the control group.
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