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SCIPIO: Cardiac Stem Cell Treatment Looks Promising in Early Results

By Yael L. Maxwell

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Intracoronary infusion of autologous cardiac stem cells safely improves left ventricular systolic function and reduces infarct size in patients with heart failure after myocardial infarction (MI), according to results of a pilot study published November 14, 2011, online ahead of print in the Lancet. The findings were released in conjunction with a presentation at the American Heart Association Scientific Sessions in Orlando, FL.

For the open-label single-center SCIPIO (Stem Cell Infusion in Patients with Ischemic cardiOmyopathy) study, Roberto Bolli, MD, of the University of Louisville (Louisville, KY), and colleagues randomized patients who had undergone CABG and who had post-infarction LV dysfunction in a 2:3 fashion to either stem cell treatment or no treatment. Patients in the treatment arm (for this analysis, n = 16; n = 7 for controls) were given autologous cardiac stem cells via intracoronary infusion at a mean of 113 days after surgery.

Baseline characteristics were similar between the 2 groups, with the exception of tobacco use being more prevalent in the control arm.

Improvements in LV Function, Infarct Size

In the 14 treated patients for whom echocardiographic results were available, LVEF increased from 30.3% before infusion to 38.5% at 4 months after infusion (P = 0.001). By contrast, in the 7 control patients, LVEF did not change over the corresponding time interval. In the 8 patients followed up at 1 year, the positive effects of stem cell treatment were even greater, with LVEF increasing by 12.3 ejection fraction units from baseline (P = 0.0007).

The increase in LVEF with stem cell treatment was paralleled by improvement in the regional wall motion score index from baseline to 4 months in the infused LV regions (1.97 vs. 1.78; P = 0.007). In the control group, there was no significant change in the regional wall motion score index, either in infarcted LV segments or in all LV segments combined.

In addition, cardiac MRI with gadolinium (performed in 7 treated patients) showed that infarct size decreased by 24% at 4 months (P = 0.004) and 30% at 1 year (P = 0.04). Measurements of LV wall thickening also showed improvement at 4 months (P = 0.01).

Although the numbers were small, treated patients also showed clinical improvements. NYHA functional class decreased from a mean of 2.19 before infusion to 1.63 at 4 months, while quality of life as assessed by the Minnesota Living with Heart Failure Questionnaire (MLHFQ) improved significantly (P < 0.0001). No such positive changes were seen in control patients.

Importantly, no adverse effects attributable to the cardiac stem cells were observed. The study is still in progress.

Benefits of an ‘Unexpected Magnitude’

Dr. Bolli and colleagues write that although the optimum dose of cardiac stem cells remains to be established, cell therapy for “patients with chronic ischemic cardiomyopathy and severe heart failure is feasible, safe, and apparently highly efficacious in restoring LV systolic function up to 1 year after treatment.”

In an editorial accompanying the publication, Gerd Heusch, MD, PhD, of the University of Essen Medical School (Essen, Germany), says the research “[raises] new optimism because the study is based on rigorous quality standards and the reported benefits are of an unexpected magnitude.”

According to Dr. Heusch, it will be important to follow these patients over a longer time period. In addition, he suggests that future trials use a “blinded protocol with coronary catheterization and a placebo infusion during a conditioning protocol, with several cycles of brief coronary occlusion and reperfusion,” so as to eliminate any bias.

Study Details

An over-the-wire balloon catheter (Quantum Maverick noncompliant balloon, Boston Scientific, Natick, MA, or Voyager RX balloon, Abbott Laboratories, Abbott Park, IL) was advanced into the proximal coronary artery or graft supplying the infarcted LV region.

The number of cardiac stem cells infused depended on the number and location of the infarcts. For example, in patients with 1 myocardial scar, 1 million cells were infused into anterior wall infarcts and 500,000 cells into infarcts within the left circumflex or right coronary artery territories.

 

Sources:
1. Bolli R, Chugh AR, D’Amario D, et al. Cardiac stem cells in patients with ischemic cardiomyopathy (SCIPIO): Initial results of a randomized phase 1 trial. Lancet. 2011;Epub ahead of print.

2. Heusch G. SCIPIO brings new momentum to cardiac cell therapy. Lancet. 2011;Epub ahead of print.

 

 

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Disclosures
  • Drs. Bolli and Heusch report no relevant conflicts of interest.

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