Autologous Stem Cell Therapy Provides Significant Benefits in Patients With Dilated Cardiomyopathy Presented at HF2009
By Chris Berrie
NICE, France -- June 6, 2009 -- Intracoronary autologous stem cell therapy provides significant benefits that are sustained for 3 years in patients with dilated cardiomyopathy, according to a randomised, controlled study presented here at the European Society of Cardiology Heart Failure Congress 2009 (HF2009).
Principal Investigator Sandeep Seth, MD, Department of Cardiology, All India Institute of Medical Sciences (AIIMS), New Delhi, India, presented this study on behalf of the AIIMS Stem Cell Study Group here on June 2.
Stem cell transplantation is known to be useful for patients with ischaemic cardiomyopathy, but evidence for a role in nonischaemic dilated cardiomyopathy is limited to some case reports and small studies.
Thus, as Dr. Seth indicated, these results represent the 3-year follow-up of an assessment of the role of intracoronary autologous stem cell transplantation in dilated cardiomyopathy.
The study included patients with dilated cardiomyopathy with normal coronaries, of a duration of >6 months, and with a left ventricular ejection fraction (LVEF) <40%. Exclusion was for severe noncardiac comorbidities or significant coronary obstructive disease.
Of the 85 patients, 20 were originally allocated to active treatment, and 65 were randomised to no stem cell transplantation (control, n = 40) or to stem cell transplantation (n = 45). The 3-year follow-up data includes all of the control group, and 41 of the active-treatment group.
Patient evaluation was based on functional capacity (one class improvement in New York Heart Association [NYHA]) and quality of life (Kansas City Cardiomyopathy Q [KCCQ]) improvements at 3 years following treatment. LVEF and histopathology were also monitored.
In the control arm, improvement in NYHA class was seen for 4 patients (10.0%), no change for 17 (42.5%), deterioration for 7 (17.5%), and death with 12 (30.0%). In contrast, the active-treatment arm saw improvements in 22 patients (53.7%), no change for 5 (12.2%), deterioration for 2 (4.9%), and death with 10 (24.4%).
For the KCCQ quality-of-life measures, there were significant improvements (P < .05) seen for active treatment that were not seen for control, both for the clinical summary (67.02 to 75.22 vs 59.95 to 61.17, respectively) and for overall summary (51.19 to 59.81 vs 51.52 to 52.74). Similarly, the LVEF saw significant improvements with active treatment (P < .05): 22.5% to 28.4% vs 20.8% to 21.2%.
Finally, histopathology from the endomyocardial biopsies showed no evidence of persisting stem cells or new immature myocytes, no evidence of inflammation, infarction, or neovascularisation, and no change in the number of capillary endothelial cells. There were, however, indications of an increased in the ratio of capillaries to myocytes.
As Dr. Seth said, "The main result here is that more than 50% of patients showed improvement, and that improvement was sustained for more than 3 years." Furthermore, as the only study with human tissue biopsies, he added, "The main change was that there was some suggestion of an increase in vascularity, although we did not see any new cells."
This absence of regeneration on histopathology thus suggests that the benefits could be due to a paracrine effect.
[Presentation title: A Randomised Trial of Autologous Bone Marrow Cells in Dilated Cardiomyopathy (ABCD). Abstract 1400]
By Chris Berrie
NICE, France -- June 6, 2009 -- Intracoronary autologous stem cell therapy provides significant benefits that are sustained for 3 years in patients with dilated cardiomyopathy, according to a randomised, controlled study presented here at the European Society of Cardiology Heart Failure Congress 2009 (HF2009).
Principal Investigator Sandeep Seth, MD, Department of Cardiology, All India Institute of Medical Sciences (AIIMS), New Delhi, India, presented this study on behalf of the AIIMS Stem Cell Study Group here on June 2.
Stem cell transplantation is known to be useful for patients with ischaemic cardiomyopathy, but evidence for a role in nonischaemic dilated cardiomyopathy is limited to some case reports and small studies.
Thus, as Dr. Seth indicated, these results represent the 3-year follow-up of an assessment of the role of intracoronary autologous stem cell transplantation in dilated cardiomyopathy.
The study included patients with dilated cardiomyopathy with normal coronaries, of a duration of >6 months, and with a left ventricular ejection fraction (LVEF) <40%. Exclusion was for severe noncardiac comorbidities or significant coronary obstructive disease.
Of the 85 patients, 20 were originally allocated to active treatment, and 65 were randomised to no stem cell transplantation (control, n = 40) or to stem cell transplantation (n = 45). The 3-year follow-up data includes all of the control group, and 41 of the active-treatment group.
Patient evaluation was based on functional capacity (one class improvement in New York Heart Association [NYHA]) and quality of life (Kansas City Cardiomyopathy Q [KCCQ]) improvements at 3 years following treatment. LVEF and histopathology were also monitored.
In the control arm, improvement in NYHA class was seen for 4 patients (10.0%), no change for 17 (42.5%), deterioration for 7 (17.5%), and death with 12 (30.0%). In contrast, the active-treatment arm saw improvements in 22 patients (53.7%), no change for 5 (12.2%), deterioration for 2 (4.9%), and death with 10 (24.4%).
For the KCCQ quality-of-life measures, there were significant improvements (P < .05) seen for active treatment that were not seen for control, both for the clinical summary (67.02 to 75.22 vs 59.95 to 61.17, respectively) and for overall summary (51.19 to 59.81 vs 51.52 to 52.74). Similarly, the LVEF saw significant improvements with active treatment (P < .05): 22.5% to 28.4% vs 20.8% to 21.2%.
Finally, histopathology from the endomyocardial biopsies showed no evidence of persisting stem cells or new immature myocytes, no evidence of inflammation, infarction, or neovascularisation, and no change in the number of capillary endothelial cells. There were, however, indications of an increased in the ratio of capillaries to myocytes.
As Dr. Seth said, "The main result here is that more than 50% of patients showed improvement, and that improvement was sustained for more than 3 years." Furthermore, as the only study with human tissue biopsies, he added, "The main change was that there was some suggestion of an increase in vascularity, although we did not see any new cells."
This absence of regeneration on histopathology thus suggests that the benefits could be due to a paracrine effect.
[Presentation title: A Randomised Trial of Autologous Bone Marrow Cells in Dilated Cardiomyopathy (ABCD). Abstract 1400]