Timing for Bone Marrow Mononuclear Cells After Acute Myocardial Infarction

The First Affiliated Hospital of Dalian Medical University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Myocardial Infarction

Treatments: Other: BMC therapy within 7-30 days; Other: BMC therapy within 24 hours; Other: PCI only; Other: BMC therapy within 3-7 days

Study type: Interventional

Funder types: Other

Identifiers

NCT02425358

2004BA714B05-2

Details and patient eligibility

About

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).

Full 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.

Enrollment: 104 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• a history of first acute ST-elevation myocardial infarction
• treatment with successful PCI two to twelve hours after symptom onset
• LVEF less than 50% on angiography immediately after emergency PCI or rescue PCI

Exclusion criteria

• previous Q-wave myocardial infarction
• cardiogenic shock
• severe coexisting conditions such as acute and chronic heart failure, malignant
• arrhythmia, renal failure and severe bleeding that interfered with the ability of the
• patient to comply with the protocol

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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104 participants in 4 patient groups

BMC therapy within 24 hours

Experimental group

Description:

Patients with acute myocardial infarction who receive intracoronary infusion of BMC within 24 hours after successful primary PCI.

Treatment:

Other: BMC therapy within 24 hours

BMC therapy within 3-7 days

Experimental group

Description:

Patients with acute myocardial infarction who receive intracoronary infusion of BMC within 3-7days after successful primary PCI.

Treatment:

Other: BMC therapy within 3-7 days

BMC therapy within 7-30 days

Experimental group

Description:

Patients with acute myocardial infarction who receive intracoronary infusion of BMC within 7-30days after successful primary PCI.

Treatment:

Other: BMC therapy within 7-30 days

PCI only

Active Comparator group

Description:

Patients with acute myocardial infarction who were performed successful primary PCI.

Treatment:

Other: PCI only