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

Primary Purpose

Myocardial Infarction

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
saline infusion
autologous bone marrow mononuclear cells infusion
Sponsored by
Xijing Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring BMMNC, STEMI, stem cell, intracoronary delivery

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Department of Cardiology in Xijing Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

1

2

Arm Description

Patients receive intracoronary injections of saline 7 days after PCI.

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

Outcomes

Primary Outcome Measures

Left Ventricular Ejection Fraction(LVEF)

Secondary Outcome Measures

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

Full Information

First Posted
February 20, 2008
Last Updated
February 28, 2008
Sponsor
Xijing Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00626145
Brief Title
Long Term Follow-up of Autologous Bone Marrow Mononuclear Cells Therapy in STEMI
Official Title
Long Term Functional Evaluation After Intracoronary Delivery of Autologous Bone Marrow Mononuclear Cells in Patients With ST-Elevation Myocardial Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
February 2008
Overall Recruitment Status
Unknown status
Study Start Date
March 2003 (undefined)
Primary Completion Date
March 2008 (Anticipated)
Study Completion Date
March 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Xijing Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
BMMNC, STEMI, stem cell, intracoronary delivery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Patients receive intracoronary injections of saline 7 days after PCI.
Arm Title
2
Arm Type
Experimental
Arm Description
Patients receive intracoronary injections of autologous bone marrow mononuclear cells 7 days after PCI.
Intervention Type
Procedure
Intervention Name(s)
saline infusion
Other Intervention Name(s)
saline placebo, placebo control
Intervention Description
Patients receive intracoronary injections of saline 7 days after PCI.
Intervention Type
Procedure
Intervention Name(s)
autologous bone marrow mononuclear cells infusion
Other Intervention Name(s)
autologous BMMC infusion, autologous bone marrow mononuclear cells transplantation, autologous BMMC intracoronary injection
Intervention Description
Patients receive intracoronary injections of autologous bone marrow mononuclear cells 7 days after PCI.
Primary Outcome Measure Information:
Title
Left Ventricular Ejection Fraction(LVEF)
Time Frame
1, 3, 6 months, 1, 4 years
Secondary Outcome Measure Information:
Title
in-stent restenosis
Time Frame
1, 3, 6 months, 1, 4 years
Title
cardiac shock
Time Frame
1, 3, 6 months, 1, 4 years
Title
myocardial viability of the infarcted area
Time Frame
1, 3, 6 months, 1, 4 years
Title
end-diastolic Volume/end-systolic Volume(EDV/ESV)
Time Frame
1, 3, 6 months, 1, 4 years
Title
wall motion score index(WMSI)
Time Frame
1, 3, 6 months, 1, 4 years
Title
cumulative MACE(including cardiac death, non-fetal myocardial infarction and target lesion revascularization)
Time Frame
1, 3, 6 months, 1, 4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haichang Wang, MD,PHD
Organizational Affiliation
Xijing Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Cardiology in Xijing Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China

12. IPD Sharing Statement

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

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