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TIME: Stem cell delivery did not improve LV function after MI
LOS ANGELES — The administration of intracoronary bone marrow mononuclear stem cells at 3 or 7 days after primary angioplasty and stenting, although safe, did not improve global or regional left ventricular function in patients with STEMI.
Jay H. Traverse, MD, of the Minneapolis Heart Institute at Abbott Northwestern Hospital and University of Minnesota Medical School, and colleagues conducted the randomized, 2 × 2 factorial, double blind, placebo-controlled TIME trial to evaluate the effects of intracoronary autologous bone marrow mononuclear cell delivery after STEMI and whether timing of delivery influences these effects.
“The optimal timing of cell delivery following MI is not known and has never been directly tested in a prospective clinical trial,” Traverse said during a presentation here at the American Heart Association Scientific Sessions 2012. “There are certain biochemical and structural changes in the myocardium and bone marrow in the first week that may create an optimal window for cell delivery.”
The researchers included 120 patients (mean age, 56.9 years; 87.5% men), all of whom underwent bone marrow aspiration and isolation of bone marrow cells using a local distributed, standardized automated system followed by intracoronary infusion of 150 million bone marrow cells or a cell-free solution within 12 hours of harvest at 3 or 7 days after PCI.
At 6 months, results showed no significant increase in LV ejection fraction in the cell therapy group (45.2% to 48.3%) compared with the placebo group (44.5% to 47.8%; P=.96). Additionally, the treatment effect on regional LV function in either the infarct or border zones was not significant.
Change in global LV function was not significantly different for patients treated at day 3 (–0.9%; 95% CI, –6.6 to 4.9) or day 7 (1.1%; 95% CI, –4.7 to 6.9). Further, the researchers found that timing of treatment did not significantly affect regional LV function recovery.
Secondary endpoints included changes in infarct size and LV volumes. Data showed small increases in LV end-diastolic and end-systolic volumes in both groups that were not significantly different. Infarct size also uniformly decreased in all patients during the 6-month period. Although the decreases in infarct size were slightly greater in the cell therapy group vs. placebo, the difference did not achieve statistical significance, Traverse said.
In a prespecified subgroup analysis, however, the researchers said younger patients assigned to cell therapy at day 7 experienced significant improvement in ejection fraction vs. placebo.
Major adverse events were uncommon in both groups.
The results of the TIME trial were simultaneously published in The Journal of the American Medical Association. – by Melissa Foster
For more information:
Traverse JH. 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.
Traverse JH. JAMA. 2012;doi:10.1001/jama.2012.28726.
Disclosure: Traverse reports no relevant financial disclosures.