NCT02425358

Timing for Bone Marrow Mononuclear Cells After Acute Myocardial Infarction

Timing for Intracoronary Administration of Bone Marrow Mononuclear Cells After Acute ST-elevated Myocardial Infarction: a Pilot Study

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: The First Affiliated Hospital of Dalian Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myocardial Infarction

Interventions

Type	Name	Description
OTHER	BMC therapy within 24 hours	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.
OTHER	BMC therapy within 3-7 days	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.
OTHER	BMC therapy within 7-30 days	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.
OTHER	PCI only	The saline was intracoronary infusion with the use of microtubular.

Timeline

• Start date: 2005-02-01
• Primary completion: 2006-08-01
• Completion: 2006-08-01
• First posted: 2015-04-24
• Last updated: 2015-04-24