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SCIPIO: Cardiac stem cells may be effective HF treatment
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LOS ANGELES — Patients with HF who received an infusion of their own cardiac stem cells experienced significant increases in viable myocardium, left ventricular systolic function and functional capacity, Roberto Bolli, MD, said during a presentation of 2-year follow-up data from the SCIPIO trial.
For the phase 1, open-label, randomized trial, Bolli and colleagues harvested cardiac tissue from 33 patients with HF who underwent CABG. They then isolated cardiac stem cells from the harvested tissue, which were almost entirely positive for c-kit, and grew additional cells. These cells were reinfused back into the same patient from whom they were harvested (n=20).
In terms of efficacy, the researchers noted no significant change in ejection fraction in the 13 control patients at 12 months. In contrast, treated patients experienced significant improvement in ejection fraction, with observed increases of 7% at 4 months, 8.1% at 1 year and 12.9% at 2 years, according to a press release.
Roberto Bolli
“This kind of analysis enables us to see how the function of the heart changes at 4, 12 and 24 months in the same patient over time among the subset of patients for whom 2-year follow-up data were available. In controls, there is no significant change over the 2 years of follow-up, but in the treated patients, you can appreciate the progressive increase in ejection fraction,” Bolli, of the Institute of Molecular Cardiology and division of cardiothoracic surgery at University of Louisville in Kentucky, said during a presentation. “A single injection of these stem cells is sufficient to improve ejection fraction for up to 2 years in these patients.”
Regional ejection fraction data showed that improvement in infarcted segments by MRI persisted at 4 months, 1 year and 2 years, with the most substantial improvement at 2 years. Bolli also said improvement was even greater in the dyskinetic segments.
Additionally, treated patients experienced a significant 46% reduction in infarct size at 2 years, accompanied by a significant increase in viable tissue 1 year. This increase was not yet statistically significant at 2 years, although 2-year follow-up data were only available for six patients, Bolli said.
At baseline, most patients were NYHA Class II. Results revealed no long-term improvement in control patients, but a stepwise, significant improvement in treated patients, which persisted and actually became more pronounced at 2 years, Bolli said. These patients experienced a 1-unit decrease in functional class; most patients were in NYHA Class I at 2 years.
Quality of life, as measured by the Minnesota Heart Failure Risk score, improved markedly in patients who received cardiac stem cells, with scores decreasing from 44.1 before treatment to 19.5 at 2 years.
The researchers found no significant adverse events that could be ascribed to the cardiac stem cells, suggesting that the treatment is safe in the short term.
“This study shows that the administration of these cells in patients with ischemic cardiomyopathy is feasible and safe, at least in the short term,” Bolli said. “Now, we need to perform larger, multicenter, randomized, blinded, phase 2 and phase 3 studies to confirm these data.” – by Melissa Foster
For more information:
Bolli R. Late-breaking clinical trials: Cell-based therapies for myocardial regeneration. Presented at: the American Heart Association Scientific Sessions 2012; Nov. 3-7, 2012; Los Angeles.
Disclosure: Bolli reports no relevant financial disclosures.