Tansplantation of autologous bone marrow derived mesenchymal stem cells trans-epicardially in patients undergoing coronary bypass surgery.

BACKGROUND: Myocardial Infarction (MI) hampers cardiac performance by ventricular remodeling which is a major cause of heart failure or death. Conventional drug therapies like beta blockers, angiotensin-converting enzyme may delay remodeling but there is no single therapeutic regimen available that can prevent or reverse the process of myocardial injury. Interventional therapies and surgical procedures improve or normalize coronary blood flow greatly. Experimental data suggests that bone marrow derived Mesenchymal Stem Cells (MSCs) may contribute to the healing of Myocardial infarction. We present our findings on the use of bone marrow derived MSCs for Myocardial Infarction wherein the cells were injected in and around the infarct region epicardially during coronary bypass surgery. METHODS & MATERIALS: 31 patients selected to undergo Coronary Artery Bypass Graft (CABG) as a treatment option for myocardial infarction formed the subject matter of our study. One patient withdrew consent before receiving our therapy and was excluded from the study. 15 patients (all men, average age 57) formed the test arm who underwent CABG plus Bone Marrow Mesenchymal Stem Cells (BMMSCs) transplantation whereas another 15 patients underwent conventional CABG only (14 men and 1 woman, mean age 57) served as the control arm. The cell transplantation consisted of injecting BMMSCs in the border zone of the clearly visible infarcted area transepicardially. The absolute number of MSCs injected ranged between 3 million and 26 million cells.
RESULTS: The data for change from baseline in the area of infarct was collected at 3 months and 6 months during the study and analyzed using paired t-tests. The mean percentage perfusion improvement from baseline in the area of infarct supplied by the Left Anterior Descending Artery (LAD) was higher in the cases (35.8%) as compared to the controls (11.3%) at 3 months post treatment (p value < 0.05). There were three cases of arrhythmia, and none of the adverse events recorded were due to the investigational product. Improvement in the ejection fraction was similar in the cases and controls.
CONCLUSIONS: This study demonstrates that trans-epicardial uses of mesenchymal stem cells are very safe and feasible. Correction of perfusion defect is very encouraging. Larger studies using higher doses of mesenchymal stem cells may bring about better understanding.