Autologous bone marrow mononuclear cell transplantation in ischemic heart failure: A prospective, controlled, randomized, double-blind study of cell transplantation combined with coronary bypass

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• 作者：Tommi Pä ; tilä ; MD ; PhD^a ; Miia Lehtinen ; MD^a ; Antti Vento ; MD ; PhD^a ; Jukka Schildt ; MD^b ; Juha Sinisalo ; MD ; PhD^c ; Mika Laine ; MD ; PhD^c ; Pekka Hä ; mmä ; inen ; MD ; PhD^a ; Anne Nihtinen ; MD ; PhD^d ; Riitta Alitalo ; MD ; PhD^e ; Pä ; ivi Nikkinen ; PhD^b ; Aapo Ahonen ; MD ; PhD^b ; Miia Holmströ ; m ; MD ; PhD^f ; Kirsi Lauerma ; MD ; PhD^f ; Reino Pö ; yhiä ; MD ; PhD^g ; Markku Kupari ; MD ; PhD^c ; Esko Kankuri ; MD ; PhD^h ; Ari Harjula ; MD ; PhD^a ; ^h ; ^{ari.harjula@hus.fi" class="auth_mail}
• 关键词：myocardial infarction ; heart failure ; bypass surgery ; bone marrow mononuclear cells ; cell therapy ; clinical trial
• 刊名：The Journal of Heart and Lung Transplantation
• 出版年：June 2014
• 年：2014
• 卷：33
• 期：6
• 页码：567-574
• 全文大小：1414 K

文摘

Bone marrow mononuclear cell (BMMC) transplantation for heart failure has shown inconsistent therapeutic efficacy.

Methods

We enrolled 104 ischemic heart failure patients scheduled for coronary artery bypass surgery (CABG). After 4- to 12-week pharmacotherapy optimization, 39 patients with left ventricular ejection fraction (LVEF) of ≤45% received injections of BMMC or vehicle intra-operatively into the myocardial infarction border area in a randomized, double-blind manner.

Results

The median number of cells injected was 8.4 × 10⁸ (interquartile range [IQR]: 5.2 × 10⁸ to 13.5 × 10⁸). We measured LV function and myocardial scar size by magnetic resonance imaging (MRI), and viability by positron emission tomography (PET) and single-photon emission computed tomography (SPECT), pre-operatively and after 1-year follow-up. LVEF, the pre-defined primary end-point measure, improved by a median of 5.6% in the control group (IQR 0.2 to 10.1) and by 4.8% in the BMMC group (IQR −0.5 to 8.2) (p = 0.59). Wall thickening in injected segments rose by a median of 4.5% among controls (IQR −18.1 to 23.9) and by 5.5% in the BMMC group (IQR −6.6 to 26.5) (p = 0.68). Changes in viability by PET and SPECT did not differ between groups. Myocardial scar size by MRI in injected segments rose by a median of 5.1% among controls (IQR −3.3 to 10.8), but fell by 13.1% in the BMMC group (IQR −21.4 to −6.5) (p = 0.0002).

Conclusions

BMMC therapy combined with CABG failed to improve LV systolic function, or viability, despite reducing myocardial scar size.