Long Term Follow-up of Autologous Bone Marrow Mononuclear Cells Therapy in STEMI

Air Force Military Medical University of People's Liberation Army

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Myocardial Infarction

Treatments: Procedure: autologous bone marrow mononuclear cells infusion; Procedure: saline infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT00626145

00200301

Details and patient eligibility

About

The benefit of current reperfusion therapies for ST-elevation myocardial infarction (STEMI) is limited by post-infarction left ventricular (LV) dysfunction. Many clinic trails showed the short term outcome of bone marrow stem cell transplantation for MI patients, but rare report of long term follow-up results. Our aim was to investigate 4 years' efficacy and LV functional improvement of autologous bone marrow mononuclear cells (BMMC) transplantation in patients with ST-elevation myocardial infarction.

Full description

The benefit of current reperfusion therapies for ST-elevation myocardial infarction (STEMI) is limited by post-infarction left ventricular (LV) dysfunction. Many clinic trails showed the short term outcome of bone marrow stem cell transplantation for MI patients, but rare report of long term follow-up results.

Aim is to evaluate the long term efficiency of unselected bone marrow mononuclear cells in treatment of patients with ST-elevation myocardial infarction (STEMI), especially with regard to the left ventricular function. The cells are delivered by intracoronary infusion 7 days after the PCI. Outcomes including LVEF, myocardial viability and coronary artery status are assessed by echocardiography, SPECT and coronary angiography.

Enrollment: 37 patients

Sex: All

Ages: 45 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ST segment elevation myocardial infarction, according to the WHO definition.
• <24 hour from the origin of symptoms.
• Single left anterior descending coronary artery disease.
• Successful revascularization of culprit lesion with PCI.
• Age between 45 and 65 years old.
• Written informed consent.

Exclusion criteria

• Previous MI.
• Cardiomyopathy.
• Atrial fibrillation or fluctuation.
• Previous heart surgery.
• Severe valvular heart disease.
• Disease of the hematopoetic system.
• NYHA functional class IV at baseline.
• Severe renal, lung and liver disease or cancer.
• Significant coronary lesion in one or more major coronary vessels, requiring revascularization.
• Intra-cardiac thrombus.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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37 participants in 2 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Patients receive intracoronary injections of saline 7 days after PCI.

Treatment:

Procedure: saline infusion

2

Experimental group

Description:

Patients receive intracoronary injections of autologous bone marrow mononuclear cells 7 days after PCI.

Treatment:

Procedure: autologous bone marrow mononuclear cells infusion