Cardiac Stem Cells in Patients With Ischaemic Cardiomyopathy (SCIPIO): Initial Results of a Randomised Phase 1 Trial

Study Questions:

What is the effect of cardiac stem cell (CSC) infusion on post-myocardial infarction (MI) left ventricular (LV) function?

Methods:

Patients with post-MI LV dysfunction (ejection fraction [EF] ≤40%) before CABG were randomly assigned to treatment or control group (2:3 ratio). One million autologous c-kit-positive, lineage-negative CSCs were administered by intracoronary infusion 113 days after surgery, whereas the control group received no treatment. The primary endpoint was short-term safety of CSCs and the secondary endpoint was efficacy.

Results:

No CSC-related adverse effects were reported. In 14 CSC-treated patients, LVEF increased from 30.3 ± 1.9% before CSC infusion to 38.5 ± 2.8% at 4 months following infusion (p = 0.001), whereas in seven control patients, LVEF did not change (30.1 ± 2.4% vs. 30.2 ± 2.5%). The beneficial effects of CSCs were even more pronounced at 1 year in eight patients (LVEF increased by 12.3 ± 2.1% vs. baseline, p = 0.0007). In seven treated patients, MRI confirmed a significant reduction in infarct size at 4 months and 1 year.

Conclusions:

The authors concluded that intracoronary infusion of autologous CSCs is effective in improving LV systolic function and reducing infarct size in patients with heart failure after myocardial infarction, and warrant further, larger, phase 2 studies.

Perspective:

Repair of infarcted myocardium remains one of the holy grails of cardiology. Cell-based therapies hold great promise, but several previous clinical studies have reported modest or negative results. Even in trials with positive results, the mechanism(s) by which transplanted cells confer benefit remains obscure. The current trial casts a ray of hope on this field and suggests that if the correct cell type is used, this approach may work. However, this is an interim analysis from an ongoing study and additional patients and follow-up will be needed to confirm these exciting preliminary results.

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention

Keywords: Myocardial Infarction, Myocardial Ischemia, Follow-Up Studies, Ventricular Function, Left, Cardiovascular Diseases, Stroke Volume, Coronary Artery Bypass


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