Motivation: With the recent AHA conference, a flurry of new findings has been released. Although there have been many negative findings, there was one recent trial in particular that caught my attention. Wouldn't it be nice if we could somehow regrow heart cells in patients with heart failure? People have tried it in the past and failed. But, there was a recent report of success!
Paper: Bolli, R. et. al. "Cardiac stem cells in patients with ischaemic cardiomyopathy (SCIPIO): initial results of a randomised phase 1 trial" Lancet (2011) epub.
Methods: The full trial consisted of an early safety analysis and then a randomized portion. Given low recruitment so far, the reported results combine the results of the whole experience. The trial included patients of (1) less than 75 who were (2) undergoing CABG with (3) LVEF <= 40% and (4) history of previous MI. Initial screening occurred at time of CABG during which the right atrial appendage was harvested and cardiac stem cells bearing cell surface marker c-kit were isolated. At a mean of 113 days after CABG, the cardiac stem cells were infused into the infarcted territory using a balloon catheter.
Results:
Subjects: In total, 16 patients received stem cells while there were seven patients in the control group. The two groups were overall similar in terms of age, gender, and comorbidities though the number of patients in each group is obviously very small.
Treatment Effect: At four month follow-up, the left ventricular ejection fraction (LVEF) increased from mean of 30.3% to 38.5% (p = 0.001). By contrast, in the controls, the LVEF remained unchanged from mean of 30.1% to 30.2%. The authors had injected the stem cells into the infarcted territory of previous MI. In the infused territory, the regional wall motion score improved significantly (1.97 to 1.78, p = 0.007), with lower scores indicating less wall motion defect. The regional wall motion score did not change in the control group.
Cardiac MRI: Seven patients treated with cardiac stem cells underwent cardiac MRI to assess mean infarct weight. In the seven patients, the mean infarct weight decreased by 7.8 g (standard error, 1.7 g) at four months. A reduction in infarct size was also noted.
Functional Data: In the stem cell treated patient, the NYHA functional class decreased from mean of 2.19 to 1.63 four months after infusion. The NYHA class of control patients stayed identical.
Adverse effects: No serious adverse effects occurred more frequently in the treatment group including MI, arrhythmia, new tumor, or stroke.
Discussion: The trial is pretty exciting because it shows that a one-time procedure of stem cell infusion can generate long-lasting benefits including ejection fraction increase and functional benefit in terms NYHA heart failure severity. This trial, however, must be taken in the context of a proof-of-concept safety analysis trial. The number of patients in each group is pretty small. Also, the entire trial was not randomized, and there may have been non-obvious differences in the two cohorts. Despite media hype about this trial, both of these are strong limitations in extending stem cell infusions to routine practice just now. Nonetheless, this trial provides hope that rather than just thinking about slowing down the pace of heart failure progression, we may actually in the future think about reversing heart failure. Perhaps, in the future, standard therapy for STEMI will be PCI with stem cell infusion. There is much more to come from this field!
Paper: Bolli, R. et. al. "Cardiac stem cells in patients with ischaemic cardiomyopathy (SCIPIO): initial results of a randomised phase 1 trial" Lancet (2011) epub.
Methods: The full trial consisted of an early safety analysis and then a randomized portion. Given low recruitment so far, the reported results combine the results of the whole experience. The trial included patients of (1) less than 75 who were (2) undergoing CABG with (3) LVEF <= 40% and (4) history of previous MI. Initial screening occurred at time of CABG during which the right atrial appendage was harvested and cardiac stem cells bearing cell surface marker c-kit were isolated. At a mean of 113 days after CABG, the cardiac stem cells were infused into the infarcted territory using a balloon catheter.
Results:
Subjects: In total, 16 patients received stem cells while there were seven patients in the control group. The two groups were overall similar in terms of age, gender, and comorbidities though the number of patients in each group is obviously very small.
Treatment Effect: At four month follow-up, the left ventricular ejection fraction (LVEF) increased from mean of 30.3% to 38.5% (p = 0.001). By contrast, in the controls, the LVEF remained unchanged from mean of 30.1% to 30.2%. The authors had injected the stem cells into the infarcted territory of previous MI. In the infused territory, the regional wall motion score improved significantly (1.97 to 1.78, p = 0.007), with lower scores indicating less wall motion defect. The regional wall motion score did not change in the control group.
Cardiac MRI: Seven patients treated with cardiac stem cells underwent cardiac MRI to assess mean infarct weight. In the seven patients, the mean infarct weight decreased by 7.8 g (standard error, 1.7 g) at four months. A reduction in infarct size was also noted.
Functional Data: In the stem cell treated patient, the NYHA functional class decreased from mean of 2.19 to 1.63 four months after infusion. The NYHA class of control patients stayed identical.
Adverse effects: No serious adverse effects occurred more frequently in the treatment group including MI, arrhythmia, new tumor, or stroke.
Discussion: The trial is pretty exciting because it shows that a one-time procedure of stem cell infusion can generate long-lasting benefits including ejection fraction increase and functional benefit in terms NYHA heart failure severity. This trial, however, must be taken in the context of a proof-of-concept safety analysis trial. The number of patients in each group is pretty small. Also, the entire trial was not randomized, and there may have been non-obvious differences in the two cohorts. Despite media hype about this trial, both of these are strong limitations in extending stem cell infusions to routine practice just now. Nonetheless, this trial provides hope that rather than just thinking about slowing down the pace of heart failure progression, we may actually in the future think about reversing heart failure. Perhaps, in the future, standard therapy for STEMI will be PCI with stem cell infusion. There is much more to come from this field!
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