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

February 28, 2008 updated by: Xijing Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

37

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Department of Cardiology in Xijing Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 1
Patients receive intracoronary injections of saline 7 days after PCI.
Procedure: saline infusion
Patients receive intracoronary injections of saline 7 days after PCI.
Other Names:
  • placebo control
  • saline placebo
Experimental: 2
Patients receive intracoronary injections of autologous bone marrow mononuclear cells 7 days after PCI.
Procedure: autologous bone marrow mononuclear cells infusion
Patients receive intracoronary injections of autologous bone marrow mononuclear cells 7 days after PCI.
Other Names:
  • autologous BMMC infusion
  • autologous bone marrow mononuclear cells transplantation
  • autologous BMMC intracoronary injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Left Ventricular Ejection Fraction(LVEF)
Time Frame: 1, 3, 6 months, 1, 4 years
1, 3, 6 months, 1, 4 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital

Investigators

  • Principal Investigator: Haichang Wang, MD,PHD, Xijing Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2003

Primary Completion (Anticipated)

March 1, 2008

Study Completion (Anticipated)

March 1, 2008

Study Registration Dates

First Submitted

February 20, 2008

First Submitted That Met QC Criteria

February 28, 2008

First Posted (Estimate)

February 29, 2008

Study Record Updates

Last Update Posted (Estimate)

February 29, 2008

Last Update Submitted That Met QC Criteria

February 28, 2008

Last Verified

February 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00200301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe