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Human mesenchymal stem cells safe for use in patients after MI
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Patients with MI receiving an infusion of human mesenchymal stem cells displayed no safety signals and improved in several measures after the stem cell therapy, new study results suggest.
Researchers enrolled 53 patients with MI (either STEMI or non-STEMI) in the study and randomly assigned them to receive a single intravenous infusion of bone marrow-derived human mesenchymal stem cells (n=34) or placebo (n=19). The primary study endpoint was the incidence of treatment-emergent adverse events within six months. Ejection fraction and left ventricular volumes were included as exploratory secondary efficacy endpoints.
The researchers reported 313 adverse events over the study period. No trend within any adverse event class suggested an increased likelihood of adverse events in the cell-treated group vs. placebo. In addition, there was a fourfold decrease in the arrhythmia event rate in the cell-treated group vs. placebo (8.8% vs. 36.8%, P=.025). There was an improvement in LV ejection fraction at three months in the cell-treated group vs. placebo, although the difference between groups was not sustained at six months. Reductions in ventricular tachycardia episodes and improved expiratory volumes (P=.003) were also reported in the cell-treated group vs. placebo. A global assessment of overall patient health suggested that patients in the cell-treated group were judged to have improved overall conditions at six months vs. those receiving placebo (42% vs. 11%, P=.027), and that the conditions of those in the cell-treated group remained higher while those judged as improved in the placebo group declined over the course of the study (from 47% at 10 days to 11% at six months, P=.016).
“Importantly, this study met its primary objective and demonstrated safety both with regard to acute infusions of human mesenchymal stem cells as well as long-term absence of ectopic tissue formation,” the researchers said. “These findings support the conduct of more extensive studies assessing the value of allogeneic human mesenchymal stem cells for the treatment of CV disorders.”
In an accompanying editorial, Mark S. Penn, MD, PhD, director of the experimental animal laboratory at the Lerner Research Institute in Cleveland, and colleagues noted that the study results, although not powered to demonstrate true efficacy, suggest promise for the use of allogeneic stem cells without immunosuppression for the treatment of acute MI.
“This study represents an important step along the path toward defining strategies for optimization of LV function after acute MI,” they wrote in the editorial. “With only modest observed benefits with initial studies of cell therapy, many questions remain, but there is excitement in what the future holds with regard to advances in this field. Hare et al are to be congratulated on the completion of this highly novel protocol that serves to highlight that the careful translation of well-founded preclinical strategies can be done safely and offers hope for improved patient outcomes in the future.”
For more information:
- Hare JM. J Am Coll Cardiol. 2009;54:2277-2286.
- Penn MS. J Am Coll Cardiol. 2009;2287-2289.