Randomization and intervention
microvascular obstruction, myocardial infarction, Vessel occlusion, arterial occlusion, TIMI
MYOCARDIAL INFARCTION, ARTERIAL OCCLUSION, COMPLICATIONS
Patients were randomized using a web-based randomization service (According to previous clinical and animal model studies, among the various sources of MSCs including bone marrow, adipose tissue, cord blood, Wharton’s jelly, etc., WJ-MCS were more efficacious in myocardial infarction and showed lower immunogenicity, higher immunomodulatory effect, smaller cell sizes and higher replication rate [The reason for transplanting 10 million cells goes back to the animal studies showing that a higher number of MSCs may cause microvascular obstruction [On each day of infusion, fresh cGMP-certified clinical-grade hWJ-MSCs (Cell Tech Pharmed Co. Ltd., Tehran, Iran) were transported to the catheterization laboratory in 0.9% normal saline. Cells were provided at the same day that procedure was planned to be performed from a cell bank. Qualification was performed according to GMP grade qualification protocols, and viability was assessed with methylene blue before transplantation. More details are provided on the published protocol of study [The patients were returned to the catheterization laboratory and received heparin if their activating clotting time was below 200 s. A therapeutic 6-Fr guiding catheter was inserted into the left main artery, and 200 μg of nitroglycerin was infused using the guiding catheter. Coronary angiography was done, and TIMI flow was documented. A 0.014-inch soft-tipped guidewire wire was entered into LAD distal to the stent. Vessel occlusion was achieved by inserting and inflating an over-the-wire balloon within the stented area. After removing the guidewire, an infusion syringe was connected to the infusion catheter. The micro-infusion of MSCs was initiated at 2.5 ml/min, and the cells were infused in three equal portions. Prior to the infusion of each portion, total arterial occlusion was confirmed through dye injection, and TIMI coronary flow was assessed. Intracoronary cell infusion complications were averted by the use of low balloon inflation pressure [2–4 bar] and divided infusion portions.