Timing for Bone Marrow Mononuclear Cells After Acute Myocardial Infarction
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Most studies on intracoronary bone marrow mononuclear cell (BMC) transplantation for acute
      myocardial infarction (AMI) involve treatment 3-7 days after primary percutaneous coronary
      intervention (PCI); however, the optimal timing is unknown. The present study assessed the
      therapeutic effect at different times after ST-elevation myocardial infarction (STEMI).
    

Detailed description: 
      On the basis of experimental studies that bone marrow mononuclear cells (BMCs) transfer in
      the injured tissue can promote regional myocardial perfusion and improved cardiac function,
      several clinical trials have shown that intracoronary bone marrow mononuclear cell (BMC)
      transplantation in acute myocardial infarction (AMI) patients several days after myocardial
      reperfusion is safe and may enhance the improvement of left ventricular ejection fraction
      (LVEF). The timing of BMC administration, baseline LVEF, dosage of BMC and other factors has
      been linked to improvement in LVEF after BMC transplantation. In our previous work, we gave
      BMCs within 24 hours after emergency percutaneous coronary intervention (PCI) and found that
      it was safe and effective . In addition, there are another report about longer time from
      symptom onset to BMC infusion (2-4 weeks), which also appeared effective . The timing of
      intracoronary stem cell administration may have a critical effect on cell engraftment and may
      be responsible for the various biological and functional responses to therapy. However, few
      studies have directly addressed the optimal timing of cell injections. Therefore, in this
      prospective randomized study, BMCs were given at different times (within 24 hours, 3 to 7
      days, or 7 to 30 days after reperfusion) to investigate whether the timing of therapy affects
      the therapeutic response of AMI patients.
    

Intervention name(s): BMC therapy within 24 hours; BMC therapy within 3-7 days; BMC therapy within 7-30 days; PCI only
Intervention type(s): Other; Other; Other; Other
Intervention description(s): The BMCs were isolated by Ficoll density gradient centrifugation on Lymphocyte Separation Medium. BMCs were infused into IRA at the site of the previous occlusion. This was accomplished with the use of a microtubular. After positioning of the microtubular into the distal segment vessel of the stent position in the infarct-related artery, 15 milliliter of the whole cell suspension was slowly administered via microtubular. The usual time should be over 10min to prevent back-flow and to prolong cellular contact time for cellular migration into the tissue. Patients in BMC therapy group within 24 hours remained in the cath-lab until the entire procedure, including primary PCI and intracoronary BMC infusion, was completed.; Patients in this group, who underwent a second procedure, to receive BMC transplantation in the cath-lab during the same hospitalization or returned for a second hospitalization.; Patients in this group, who underwent a second procedure, to receive BMC transplantation in the cath-lab during the same hospitalization or returned for a second hospitalization.; The saline was intracoronary infusion with the use of microtubular.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cell therapy; BMC; timing