Bone marrow mesenchymal stem cells transfer in patients with ST-segment elevation myocardial infarction: single-blind, multicentre, randomized controlled trial

Objective: Our aim was to evaluate the efficacy and safety of intracoronary autologous bone morrow mesenchymal stem cells (BM-MSCs) transplantation in patients with ST-segment elevation myocardial infarction (STEMI). Methods: In this randomized, single-blind, controlled trial, patients with STEMI (aged 39-76 years) were enrolled at 6 centers in Beijing (the People's Liberation Army Navy General Hospital, Beijing Armed Police General Hospital, Chinese People's Liberation Army General Hospital, Beijing Huaxin Hospital, Beijing Tongren Hospital, Beijing Chaoyang Hospital West Hospital). All patients underwent optimum medical treatment and percutaneous coronary intervention, and were randomly assigned in a 1:1 ratio to BM-MSCs group or control group. The primary endpoint was the change of myocardial viability at the 6th month's follow-up and left-ventricular (LV) function at the 12th month's follow-up.The secondary endpoints were the incidence of cardiovascular event, total mortality and adverse event during the 12 months' follow-up. The myocardial viability assessed by single- photon emission tomography (SPECT). The left ventricular ejection fraction was used to assess LV function. All patients underwent dynamic ECG and laboratory evaluations. This trial is registered with ClinicalTrails.gov, number NCT04421274. Results: Between March 2008, and July 2010, 43 patients who had underwent optimum medical treatment and successful percutaneous coronary intervention were randomly assigned to BM-MSCs group (n=21)or control group (n=22) and followed up for 12 months. At the 6th month's follow-up, there was no significant improvement in myocardial activity in the BM-MSCs group before and after transplantation. Meanwhile, there was no statistically significant difference between the two groups in the change of myocardial perfusion defect index (p=0.90) and myocardial metabolic defect index (p=0.37). The LV ejection fraction increased from baseline to 12 months in the BM-MSCs group and control group ( mean baseline-adjusted BM-MSCs treatment differences in LV ejection fraction 4.8% (SD 9.0) and mean baseline-adjusted control group treatment differences in LV ejection fraction 5.8% (SD 6.04) ). However, there was no statistically significant difference between the two groups in the change of the LV ejection fraction (p=0.23). We noticed that during the 12 months' follow-up, except for one death and one coronary microvascular embolism in the BM-MSCs group, no other events occurred and Alanine transaminase (ALT) and C-reactive protein (CRP) in BM-MSCs group were significantly lower than that in control group. Conclusions: The present study may have many methodological limitations, and within those limitations, we did not identify that intracoronary transfer of autologous BM-MSCs could largely promote the recovery of LV function and myocardial viability after acute myocardial infarction.