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

Phase 1

• Conditions: Myocardial Infarction
• Interventions: Procedure: saline infusion; Procedure: autologous bone marrow mononuclear cells infusion

• Registration Number: NCT00626145
• Lead Sponsor: Xijing Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2003-03
• Status Verified: 2008-02
• Study First Submitted: 2008-02-20
• Study First Submitted QC: 2008-02-28
• Last Update Submitted: 2008-02-28
• Study First Posted: 2008-02-29
• Last Update Posted: 2008-02-29
• Primary Completion: 2008-03
• Study Completion: 2008-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 37

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	saline infusion	Patients receive intracoronary injections of saline 7 days after PCI.
2	autologous bone marrow mononuclear cells infusion	Patients receive intracoronary injections of autologous bone marrow mononuclear cells 7 days after PCI.

Primary Outcome Measures

Name	Time	Method
Left Ventricular Ejection Fraction(LVEF)	1, 3, 6 months, 1, 4 years

Secondary Outcome Measures

Name	Time	Method
in-stent restenosis	1, 3, 6 months, 1, 4 years
cardiac shock	1, 3, 6 months, 1, 4 years
myocardial viability of the infarcted area	1, 3, 6 months, 1, 4 years
end-diastolic Volume/end-systolic Volume(EDV/ESV)	1, 3, 6 months, 1, 4 years
wall motion score index(WMSI)	1, 3, 6 months, 1, 4 years
cumulative MACE(including cardiac death, non-fetal myocardial infarction and target lesion revascularization)	1, 3, 6 months, 1, 4 years

Trial Locations

Locations (1)

Department of Cardiology in Xijing Hospital; 🇨🇳 Xi'an, Shaanxi, China