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

Purpose

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.

Condition	Intervention	Phase
Myocardial Infarction	Procedure: saline infusion Procedure: autologous bone marrow mononuclear cells infusion	Phase 1 Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Long Term Functional Evaluation After Intracoronary Delivery of Autologous Bone Marrow Mononuclear Cells in Patients With ST-Elevation Myocardial Infarction

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack

U.S. FDA Resources

Further study details as provided by Xijing Hospital:

Primary Outcome Measures:

Left Ventricular Ejection Fraction(LVEF) [ Time Frame: 1, 3, 6 months, 1, 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

in-stent restenosis [ Time Frame: 1, 3, 6 months, 1, 4 years ] [ Designated as safety issue: Yes ]
cardiac shock [ Time Frame: 1, 3, 6 months, 1, 4 years ] [ Designated as safety issue: Yes ]
myocardial viability of the infarcted area [ Time Frame: 1, 3, 6 months, 1, 4 years ] [ Designated as safety issue: No ]
end-diastolic Volume/end-systolic Volume(EDV/ESV) [ Time Frame: 1, 3, 6 months, 1, 4 years ] [ Designated as safety issue: No ]
wall motion score index(WMSI) [ Time Frame: 1, 3, 6 months, 1, 4 years ] [ Designated as safety issue: No ]
cumulative MACE(including cardiac death, non-fetal myocardial infarction and target lesion revascularization) [ Time Frame: 1, 3, 6 months, 1, 4 years ] [ Designated as safety issue: Yes ]

Enrollment:	37
Study Start Date:	March 2003
Estimated Study Completion Date:	March 2008
Estimated Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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: saline placebo placebo control
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

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.

Eligibility

Ages Eligible for Study:	45 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00626145

Locations

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

Sponsors and Collaborators

Xijing Hospital

Investigators

Principal Investigator:

Haichang Wang, MD,PHD

Xijing Hospital

More Information

No publications provided

Responsible Party:	Haichang Wang / Director of Department of Cardiology of Xijing Hospital, Xijing Hospital of Fourth Military Medical University
ClinicalTrials.gov Identifier:	NCT00626145 History of Changes
Other Study ID Numbers:	00200301
Study First Received:	February 20, 2008
Last Updated:	February 28, 2008
Health Authority:	China: Food and Drug Administration

Keywords provided by Xijing Hospital:

BMMNC
STEMI
stem cell
intracoronary delivery

Additional relevant MeSH terms:

Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis

Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013