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

NCT ID: NCT00626145

Last Updated: 2008-02-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2008-03-31

Brief Summary

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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

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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.

Conditions

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Myocardial Infarction

Keywords

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BMMNC STEMI stem cell intracoronary delivery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Patients receive intracoronary injections of saline 7 days after PCI.

Group Type PLACEBO_COMPARATOR

saline infusion

Intervention Type PROCEDURE

Patients receive intracoronary injections of saline 7 days after PCI.

2

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

Group Type EXPERIMENTAL

autologous bone marrow mononuclear cells infusion

Intervention Type PROCEDURE

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

Interventions

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saline infusion

Patients receive intracoronary injections of saline 7 days after PCI.

Intervention Type PROCEDURE

autologous bone marrow mononuclear cells infusion

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

Intervention Type PROCEDURE

Other Intervention Names

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saline placebo placebo control autologous BMMC infusion autologous bone marrow mononuclear cells transplantation autologous BMMC intracoronary injection

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xijing Hospital of Fourth Military Medical University

Principal Investigators

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Haichang Wang, MD,PHD

Role: PRINCIPAL_INVESTIGATOR

Xijing Hospital

Locations

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Department of Cardiology in Xijing Hospital

Xi'an, Shaanxi, China

Site Status

Countries

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China

Other Identifiers

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00200301

Identifier Type: -

Identifier Source: org_study_id