Status:
UNKNOWN
Stem Cell Therapy to Improve Myocardial Function in Patients Undergoing Coronary Artery Bypass Grafting (CABG)
Lead Sponsor:
China National Center for Cardiovascular Diseases
Conditions:
Coronary Disease
Myocardial Infarction
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to determine whether intracoronary transfer of autologous bone marrow cells can induce angiogenesis, subsequently improving regional myocardial perfusion, and finally resu...
Detailed Description
This research study is being performed to find out more information about the safety and efficacy of autologous bone marrow stem cells transplantation. In patients with myocardial infarction, the hear...
Eligibility Criteria
Inclusion
- Patients with coronary disease undergoing CABG.
- At least 3 months since last episode of myocardial infarction
- Patients fulfilling either of the following criteria based on the extent of CAD by coronary angiography and LVEF by echocardiography.
- Reversible myocardial ischemia as revealed by SPECT. ejection fraction \>=40% \<=50%. Age \>=18 years and \<=70 Patients who can give informed consent themselves in writing.
- Negative pregnancy test (in women with childbearing potential).
Exclusion
- Any one of the following exclusion criteria is sufficient to disqualify a patient from the study.
- Sustained ventricular tachycardia in a 24-hour ECG.
- Chronic atrial fibrillation.
- Less than 3 months since last episode of cerebral infarction.
- Patients with a malignant tumor\*.
- Patients with chronic rheumatoid arthritis.
- Patients with a history of severe allergic reactions.
- Patients with hematological disease (leukemia, myeloproliferative disease, or myelodysplastic syndromes).
- Patients currently suffering from or having a history of interstitial pneumonitis.
- Leukocytes less than 4,000/µL or exceeding 10,000/µL.
- Platelets less than 100,000/µL.
- Hemoglobin less than 10 g/dL.
- AST (GOT) exceeding 100 IU/L or ALT (GPT) exceeding 100 IU/L.
- Patients for whom it is impossible to perform both cardiac MRI
- Pregnant or nursing patients, those who may be pregnant, or those who plan on becoming pregnant before the end of the study period.
- Any other reason that the Clinical Supervisors or Clinical Researchers may have for considering a case unsuitable for the study.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2009
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00395811
Start Date
January 1 2007
End Date
June 1 2009
Last Update
October 29 2008
Active Locations (1)
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1
Fuwai cardiovascular disease hospital
Beijing, China, 100037