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Randomized Controlled Trial
. 2009 Aug;30(16):1986-94.
doi: 10.1093/eurheartj/ehp220. Epub 2009 Jun 9.

Long-term myocardial functional improvement after autologous bone marrow mononuclear cells transplantation in patients with ST-segment elevation myocardial infarction: 4 years follow-up

Feng Cao  1 , Dongdong Sun, Chengxiang Li, Kazim Narsinh, Li Zhao, Xue Li, Xuyang Feng, Jun Zhang, Yunyan Duan, Jing Wang, Dingjing Liu, Haichang Wang
Affiliations
Randomized Controlled Trial

Long-term myocardial functional improvement after autologous bone marrow mononuclear cells transplantation in patients with ST-segment elevation myocardial infarction: 4 years follow-up

Feng Cao et al. Eur Heart J. 2009 Aug.

Abstract

Aims: To evaluate the safety profile and efficacy of bone marrow mononuclear cells (BMMNC) transplantation for ST-segment elevation myocardial infarction (STEMI) by assessing patients and their left ventricular function at up to 4 years follow-up.

Methods and results: Eighty-six patients with STEMI who had successfully undergone percutaneous coronary intervention (PCI) were randomized to receive intracoronary injection of BMMNC (n = 41) or saline (n = 45). Left ventricular ejection fraction, as evaluated by UCG, was markedly improved at 6 months (0.484 +/- 0.5 vs. 0.457 +/- 0.6, P = 0.001), 1 year (0.482 +/- 0.7 vs. 0.446 +/- 0.6, P < 0.001), and 4 years (0.505 +/- 0.8 vs. 0.464 +/- 0.8, P < 0.001) after BMMNC transplant when compared with control group. However, the current cell therapy did not improve the myocardial viability of the infarcted area as assessed by single-photon emission computed tomography analysis at 4 years post-transplant (0.263 +/- 0.007 in BMMNC group vs. 0.281 +/- 0.008 in control group, P = 0.10). During the follow-up period, one control group case (2.2%) of in-stent restenosis was confirmed by coronary angiography and underwent repeat PCI. Also during follow-up, one death (2.2%) occurred in the control group, and one patient (2.4%) in the BMMNC group had transient acute heart failure.

Conclusion: This study indicates that intracoronary delivery of autologous BMMNC is safe and feasible for STEMI patients who have undergone PCI, and can lead to long-term improvement in myocardial function.

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Figures

Figure 1
Figure 1
Flowchart outlining the study protocol.
Figure 2
Figure 2
Improvement of LVEF and ESV evaluated by echocardiography. LVEF and ESV changes were recorded in a representative patient from baseline (Day 7) to 4 years after MI. (A) LVEF measured at 6 months, 1 and 4 years’ follow-up was increased significantly in the BMMNC group when compared with the control group (B). ESV in the BMMNC group was decreased significantly more than in the control group at 6 months, 1 and 4 years follow-up (*P < 0.05 vs. control) (C). Changes in LVEF and ESV between Day 7 and 4 year were significant in the BMMNC group (D–G). LVEF, left ventricular ejection fraction; ESV, end-systolic volume. Solid circles represent the mean, T bars the standard error (SE).
Figure 3
Figure 3
Changes of EDV and WMSI between Day 7 and 4 years after the myocardial infarction evaluated by echocardiography. Changes in EDV between Day 7 and 4 year were not significantly different between the two groups (A and B). WMSI improved significantly in the BMMNC group compared with control (C and D). EDV, end-diastolic volume; WMSI, wall motion score index. Solid circles represent the mean, T bars the standard error (SE).
Figure 4
Figure 4
Infarct size evaluated by single-photon emission computed tomography analysis (SPECT). Infarct size decreased in both the bone marrow mononuclear cells (BMMNC) and the control group (A and B). Comparison of infarct size between the two groups showed no statistical difference (C). Changes in infarct size between Day 7 and 4 years follow-up were not significantly different between the two groups (D).
Figure 5
Figure 5
Subgroup analysis. Principle transverse lines represented the mean changes in left ventricular ejection fraction (LVEF) between baseline and 4 years follow-up. DM, diabetes mellitus; Non-D, non-diabetic patients; HBP, high blood pressure; NBP, normal blood pressure; HL, hyperlipidaemia; NL, normal lipidaemia.
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