Status:
TERMINATED
Stem Cell Study for Patients With Heart Disease
Lead Sponsor:
Foundation for Biomedical Research and Innovation
Collaborating Sponsors:
Institute of Biomedical Research and Innovation, Kobe, Hyogo, Japan
Kobe City General Hospital
Conditions:
Chest Pain
Chronic Myocardial Ischemia
Eligibility:
All Genders
20-80 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to determine if stem cell therapy with your own cells (autologous cells) delivered with a catheter to regions of the heart with poor blood flow will be safe and if it will...
Detailed Description
Chronic myocardial ischemia (MI) is a progressive disease, which arises as a result of atherosclerosis in coronary arteries. Prognosis of chronic MI is poor, and no effective treatments have been esta...
Eligibility Criteria
Inclusion
- Chronic severe CAD patients fulfilling all the following criteria are considered suitable for inclusion in the study.
- At least 6 months since last episode of myocardial infarction or at least 3 months since initial anginal episode.
- Patients fulfilling either of the following criteria based on the extent of CAD by coronary angiography and LVEF by echocardiography.
- Patients with single vessel CAD and LVEF \< 50%
- Patients with multivessel CAD
- Reversible myocardial ischemia as revealed by sestamibi SPECT stress myocardial scintigraphy.
- Patients for whom angioplasty and bypass are not indicated because of anatomical or procedural reasons or frequent reocclusion/restenosis following traditional revascularization.
- Age is between 20 and 80 (at time of consent).
- Exercise tolerance time (ETT) duration ≥ 3 minutes and \< 13 minutes on a modified Bruce protocol on 2 consecutive tests (\> 24 hours but \< 2 weeks apart), with the difference between the 2 exercise times within 25% of their mean (Patients should not be informed of exercise restrictions required for entry into the study).
- Patients who can give informed consent themselves in writing.
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 6 months since last episode of cerebral infarction.
- Less than 6 months since last coronary angioplasty or less than 3 months since last bypass surgery.
- Patients with unstable angina, with a treatment rating of 3 in the Braunwald system (refer to 5.4.), but a severity of III and a clinical rating of B or C.
- Presence of left ventricular thrombus by echocardiography
- Patients with a malignant tumor\*.
- Patients with diabetic proliferating retinopathy\*\* (new Fukuda classification BI to BV).
- Patients with chronic rheumatoid arthritis.
- Patients with a history of severe allergic reactions or side effects to G-CSF preparations or apheresis.
- Patients with hematological disease (leukemia, myeloproliferative disease, or myelodysplastic syndromes).
- Patients currently suffering from or having a history of interstitial pneumonitis.
- Patients for whom cranial MRA reveals cerebral aneurysm.
- Patients for whom abdominal CT or ultrasonography reveals splenomegaly.
- Patients with cirrhosis of the liver.
- Patients who cannot discontinue Warfarin.
- 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 and left ventriculography (LVG) (see 9.2.4 for cardiac MRI details and 9.2.9 for LVG details).
- Patients with gate disturbance for reasons other than CAD (such as critical limb ischemia, sciatic neuralgia, or vasculitis), making exercise tolerance evaluation on a treadmill with stress ECG difficult.
- 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 :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00221182
Start Date
September 1 2005
End Date
September 1 2009
Last Update
June 22 2011
Active Locations (3)
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1
Kobe Institute of Biomedical Research and Innovation
Kobe, Hyogo-Pref., Japan, 650-0047
2
Kobe City General Hospital
Kobe, Hyōgo, Japan
3
Okayama University School of Medicine
Okayama, Okayama-ken, Japan, 700-8530