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Clinical Trial
. 2020 Apr;109(4):1142-1149.
doi: 10.1016/j.athoracsur.2019.07.093. Epub 2019 Sep 14.

Intramyocardial Bone Marrow Stem Cells in Patients Undergoing Cardiac Surgical Revascularization

Joshua L Chan  1 , Justin G Miller  1 , Yifu Zhou  1 , Pamela G Robey  2 , David F Stroncek  3 , Andrew E Arai  4 , Vandana Sachdev  5 , Keith A Horvath  6
Affiliations
Clinical Trial

Intramyocardial Bone Marrow Stem Cells in Patients Undergoing Cardiac Surgical Revascularization

Joshua L Chan et al. Ann Thorac Surg. 2020 Apr.

Abstract

Background: Bone marrow stromal or stem cells (BMSCs) remain a promising potential therapy for ischemic cardiomyopathy. The primary objective of this study was to evaluate the safety and feasibility of direct intramyocardial injection of autologous BMSCs in patients undergoing transmyocardial revascularization (TMR) or coronary artery bypass graft surgery (CABG).

Methods: A phase I trial was conducted on adult patients who had ischemic heart disease with depressed left ventricular ejection fraction and who were scheduled to undergo TMR or CABG. Autologous BMSCs were expanded for 3 weeks before the scheduled surgery. After completion of surgical revascularization, BMSCs were directly injected into ischemic myocardium. Safety and feasibility of therapy were assessed. Cardiac functional status and changes in quality of life were evaluated at 1 year.

Results: A total of 14 patients underwent simultaneous BMSC and surgical revascularization therapy (TMR+BMSCs = 10; CABG+BMSCs = 4). BMSCs were successfully expanded, and no significant complications occurred as a result of the procedure. Regional contractility in the cell-treated areas demonstrated improvement at 12 months compared with baseline (TMR+BMSCs Δ strain: -4.6% ± 2.1%; P = .02; CABG+MSCs Δ strain: -4.2% ± 6.0%; P = .30). Quality of life was enhanced, with substantial reduction in angina scores at 1 year after treatment (TMR+BMSCs: 1.3 ± 1.2; CABG+MSCs: 1.0 ± 1.4).

Conclusions: In this phase I trial, direct intramyocardial injection of autologous BMSCs in conjunction with TMR or CABG was technically feasible and could be performed safely. Preliminary results demonstrate improved cardiac function and quality of life in patients at 1 year after treatment.

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Figures

Figure 1.
Figure 1.
CONSORT Flow Diagram.
Figure 2.
Figure 2.
Left Ventricular Ejection Fraction as Assessed by Echocardiography. * P < 0.05 compared to baseline CABG: Coronary artery bypass graft surgery; LVEF: Left ventricular ejection fraction; BMSCs: Bone marrow stromal/stem cells; TMR: Transmyocardial revascularization
Figure 3.
Figure 3.
Wall Motion Score Index as Assessed by Echocardiography. * P < 0.05 compared to baseline CABG: Coronary artery bypass graft surgery; WMSI: Wall motion score index; BMSCs: Bone marrow stromal/stem cells; TMR: Transmyocardial revascularization
Figure 4.
Figure 4.
Regional Myocardial Contractility of Treated Segments as Assessed by Cine Cardiac Magnetic Resonance Imaging. CABG: Coronary artery bypass graft surgery; CMR: Cardiac magnetic resonance imaging; BMSCs: Bone marrow stromal/stem cells; TMR: Transmyocardial revascularization
Figure 5.
Figure 5.
Postoperative Quality of Life and Symptom Improvement. * P < 0.05 CABG: Coronary artery bypass graft surgery; CCS: Canadian Cardiovascular Society; BMCS: Mental component summary; BMSCs: Bone marrow stromal/stem cells; PCS: Physical component summary; SAQ: Seattle Angina Questionnaire; SF-36: Short Form 36 Health Survey; TMR: Transmyocardial revascularization
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