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

Myocardial Infarction Clinical Trial

Official title:

Long Term Functional Evaluation After Intracoronary Delivery of Autologous Bone Marrow Mononuclear Cells in Patients With ST-Elevation Myocardial Infarction

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00626145
• Other study ID #: 00200301
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: February 20, 2008
• Last updated: February 28, 2008
• Start date: March 2003
• Est. completion date: March 2008

Study information

• Verified date: February 2008
• Source: Xijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 37
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Procedure:
• saline infusion
Patients receive intracoronary injections of saline 7 days after PCI.
• autologous bone marrow mononuclear cells infusion
Patients receive intracoronary injections of autologous bone marrow mononuclear cells 7 days after PCI.

Locations

Country	Name	City	State
China	Department of Cardiology in Xijing Hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left Ventricular Ejection Fraction(LVEF)		1, 3, 6 months, 1, 4 years	No
Secondary	in-stent restenosis		1, 3, 6 months, 1, 4 years	Yes
Secondary	cardiac shock		1, 3, 6 months, 1, 4 years	Yes
Secondary	myocardial viability of the infarcted area		1, 3, 6 months, 1, 4 years	No
Secondary	end-diastolic Volume/end-systolic Volume(EDV/ESV)		1, 3, 6 months, 1, 4 years	No
Secondary	wall motion score index(WMSI)		1, 3, 6 months, 1, 4 years	No
Secondary	cumulative MACE(including cardiac death, non-fetal myocardial infarction and target lesion revascularization)		1, 3, 6 months, 1, 4 years	Yes