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CAUSMIC: Myoblast implantation via catheter in patients with HF feasible
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Patients who received transplanted myoblasts via catheter showed improvement in NYHA functional class, ventricular viability and quality of life measurements.
As part of a one-year follow-up to the CAUSMIC study, researchers randomly assigned patients (n=23) to receive either maximum medical therapy (n=11) or autologous myoblast transplantation plus maximum medical therapy.
The researchers reported no serious adverse events related to the transplantation. NYHA functional class improved from baseline (2.7) to three months (1.9; P<.016), from baseline to six months (1.5; P<.0043) and from baseline to one year (1.7; P<.0029) in the group receiving autologous myoblasts, with no patients in the group worsening.
The researchers also observed additional changes in quality of life measurements using the Minnesota Living with HF Questionnaire, noting improvements between baseline and one year in patients receiving the autologous myoblast transplantation (P=.004). Changes in ventricular dimensions did not attain statistical significance in either group between baseline and one year, although patients receiving autologous myoblast implantation showed a trend toward decreasing ventricular systolic and diastolic diameters.
“This study demonstrates that myoblasts can be safely and feasibly administered in patients by a transcatheter technique in the hands of a trained investigator,” the researchers wrote in their conclusion. “Training will be a key factor in the success of this technique, because not all studies have shown similar freedom from complications as shown here. Larger, randomized, double blind, placebo-controlled and multicenter clinical trials are warranted to further test this therapeutic approach.”
J Am Coll Cardiol Intv. 2009;2:9-16.
This is an important step forward but everyone needs to remember this was a safety and feasibility study rather than an efficacy determination effort. The bottom line is to stay tuned for bigger trials with more solid efficacy endpoints.
– James B. Young, MD
Cardiology Today Section Editor
