OBJECTIVE: We tested the hypothesis that direct intramyocardial injection of bone marrow mononuclear cells in patients with non-ischemic dilated cardiomyopathy can improve left ventricular function and physical capacity. METHODS:Thirty non-ischemic dilated cardiomyopathy patients with left ventricular ejection fraction <35% were randomized at a 1:2 ratio into two groups, control and treated. The bone marrow mononuclear cells group received 1.06±108 bone marrow mononuclear cells through mini-thoracotomy. There was no intervention in the control group. Assessment was carried out through clinical evaluations as well as a 6-min walk test, nuclear magnectic resonance imaging and echocardiogram. RESULTS: The bone marrow mononuclear cells group showed a trend toward left ventricular ejection fraction improvement, with magnectic resonance imaging - at 3 months, showing an increase from 27.80±6.86% to 30.13±9.06% (P=0.08) and returning to baseline at 9 months (28.78%, P=0.77). Magnectic resonance imaging showed no changes in left ventricular ejection fraction during follow-up of the control group (28.00±4.32%, 27.42±7.41%, and 29.57±4.50%). Echocardiogram showed left ventricular ejection fraction improved in the bone marrow mononuclear cells group at 3 months, 25.09±3.98 to 30.94±9.16 (P=0.01), and one year, 30.07±7.25% (P=0.001). The control group showed no change (26.1±4.4 vs 26.5±4.7 and 30.2±7.39%, P=0.25 and 0.10, respectively). Bone marrow mononuclear cells group showed improvement in New York Heart Association functional class, from 3.40±0.50 to 2.41±0.79 (P=0.002); patients in the control group showed no change (3.37±0.51 to 2.71±0.95; P=0.17). Six-minute walk test improved in the bone marrow mononuclear cells group (348.00±93.51m at baseline to 370.41±91.56m at 12 months, P=0.66) and there was a non-significant decline in the control group (361.25±90.78m to 330.00±123.42m after 12 months, P=0.66). Group comparisons were non-significant. CONCLUSION: The trend of intragroup functional and subjective improvement was not confirmed when compared to the control group. Direct intramyocardial application of bone marrow mononuclear cells in non-ischemic dilated cardiomyopathy was not associated with significant changes in left ventricular function. Differences observed within the bone marrow mononuclear cells group could be due to placebo effect or low statistical power.
RCT Entities:
OBJECTIVE: We tested the hypothesis that direct intramyocardial injection of bone marrow mononuclear cells in patients with non-ischemic dilated cardiomyopathy can improve left ventricular function and physical capacity. METHODS: Thirty non-ischemic dilated cardiomyopathypatients with left ventricular ejection fraction <35% were randomized at a 1:2 ratio into two groups, control and treated. The bone marrow mononuclear cells group received 1.06±108 bone marrow mononuclear cells through mini-thoracotomy. There was no intervention in the control group. Assessment was carried out through clinical evaluations as well as a 6-min walk test, nuclear magnectic resonance imaging and echocardiogram. RESULTS: The bone marrow mononuclear cells group showed a trend toward left ventricular ejection fraction improvement, with magnectic resonance imaging - at 3 months, showing an increase from 27.80±6.86% to 30.13±9.06% (P=0.08) and returning to baseline at 9 months (28.78%, P=0.77). Magnectic resonance imaging showed no changes in left ventricular ejection fraction during follow-up of the control group (28.00±4.32%, 27.42±7.41%, and 29.57±4.50%). Echocardiogram showed left ventricular ejection fraction improved in the bone marrow mononuclear cells group at 3 months, 25.09±3.98 to 30.94±9.16 (P=0.01), and one year, 30.07±7.25% (P=0.001). The control group showed no change (26.1±4.4 vs 26.5±4.7 and 30.2±7.39%, P=0.25 and 0.10, respectively). Bone marrow mononuclear cells group showed improvement in New York Heart Association functional class, from 3.40±0.50 to 2.41±0.79 (P=0.002); patients in the control group showed no change (3.37±0.51 to 2.71±0.95; P=0.17). Six-minute walk test improved in the bone marrow mononuclear cells group (348.00±93.51m at baseline to 370.41±91.56m at 12 months, P=0.66) and there was a non-significant decline in the control group (361.25±90.78m to 330.00±123.42m after 12 months, P=0.66). Group comparisons were non-significant. CONCLUSION: The trend of intragroup functional and subjective improvement was not confirmed when compared to the control group. Direct intramyocardial application of bone marrow mononuclear cells in non-ischemic dilated cardiomyopathy was not associated with significant changes in left ventricular function. Differences observed within the bone marrow mononuclear cells group could be due to placebo effect or low statistical power.
Authors: Saskia L M A Beeres; Douwe E Atsma; Arnoud van der Laarse; Daniël A Pijnappels; John van Tuyn; Willem E Fibbe; Antoine A F de Vries; Dirk L Ypey; Ernst E van der Wall; Martin J Schalij Journal: J Am Coll Cardiol Date: 2005-10-21 Impact factor: 24.094
Authors: Daniël A Pijnappels; Martin J Schalij; John van Tuyn; Dirk L Ypey; Antoine A F de Vries; Ernst E van der Wall; Arnoud van der Laarse; Douwe E Atsma Journal: Cardiovasc Res Date: 2006-07-29 Impact factor: 10.787
Authors: Michael Hofmann; Kai C Wollert; Gerd P Meyer; Alix Menke; Lubomir Arseniev; Bernd Hertenstein; Arnold Ganser; Wolfram H Knapp; Helmut Drexler Journal: Circulation Date: 2005-04-25 Impact factor: 29.690
Authors: Wayne C Levy; Dariush Mozaffarian; David T Linker; Santosh C Sutradhar; Stefan D Anker; Anne B Cropp; Inder Anand; Aldo Maggioni; Paul Burton; Mark D Sullivan; Bertram Pitt; Philip A Poole-Wilson; Douglas L Mann; Milton Packer Journal: Circulation Date: 2006-03-13 Impact factor: 29.690
Authors: Ahmed Abdel-Latif; Roberto Bolli; Imad M Tleyjeh; Victor M Montori; Emerson C Perin; Carlton A Hornung; Ewa K Zuba-Surma; Mouaz Al-Mallah; Buddhadeb Dawn Journal: Arch Intern Med Date: 2007-05-28
Authors: Satsuki Fukushima; Anabel Varela-Carver; Steven R Coppen; Kenichi Yamahara; Leanne E Felkin; Joon Lee; Paul J R Barton; Cesare M N Terracciano; Magdi H Yacoub; Ken Suzuki Journal: Circulation Date: 2007-04-16 Impact factor: 29.690
Authors: Antonio Carlos Campos de Carvalho; Tais H Kasai-Brunswick; Adriana Bastos Carvalho Journal: Front Pharmacol Date: 2021-04-12 Impact factor: 5.810
Authors: Rienzi Diaz-Navarro; Gerard Urrútia; John Gf Cleland; Daniel Poloni; Francisco Villagran; Roberto Acosta-Dighero; Shrikant I Bangdiwala; Gabriel Rada; Eva Madrid Journal: Cochrane Database Syst Rev Date: 2021-07-21
Authors: Evelien Nollet; Vicky Y Hoymans; Inez R Rodrigus; Dina De Bock; Marc Dom; Bruno Vanassche; Viviane O M Van Hoof; Nathalie Cools; Katrijn Van Ackeren; Kristien Wouters; Katrien Vermeulen; Christiaan J Vrints; Emeline M Van Craenenbroeck Journal: J Cardiovasc Transl Res Date: 2016-07-25 Impact factor: 4.132