500 Boylston Street, Boston, MA 02116 617-419-4700
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The purpose of this study is to determine if 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 relieve your chest pain and/or your ability to exercise.
Ages:21 and older
Inclusion Criteria: - Subjects with functional class (CCS) III or IV angina. - Subjects who have attempted "best" medical therapy without control of symptoms. - All subjects must have a recent coronary angiogram (within the last 3 months). - Clinical signs and symptoms of clinically significant ischemia on nuclear perfusion imaging. - Subjects must be able to complete a minimum of 1 minute but no more than 6 minutes of the Standard Bruce Protocol. - Subject experiences angina during the baseline exercise tolerance test. - Subjects must either be no longer capable of reproduction or taking acceptable measures to prevent reproduction during the study. - Normal renal function. - Normal liver function. - Normal blood count. Angiographic Inclusions: - Total occlusion of an epicardial coronary artery. - Candidates at high risk for percutaneous coronary angioplasty of treatment zone(s) based upon clinical or anatomic considerations including but not limited to the following: diabetes, congestive heart failure (severe right heart failure, NYHA class III or IV), left main disease, pulmonary hypertension, severe proximal vessel tortuosity, severe bendpoint obstructions, diffuse disease (>2 cm in length), small vessel (<2 mm reference diameter), stenosis which are either diffuse (>2 cm in length) or distal, incessant restenosis lesions, unfavorable bifurcation stenosis, and degenerated or thrombosed saphenous vein grafts. Exclusion Criteria: - Predominant congestive heart failure symptoms. - Patients who have been hospitalized with a primary diagnosis of CHF in the prior 6 months. - Patients who have had diuretics added to their medical regimen or an increase in diuretic dosage for signs or symptoms of CHF in the past 6 months. - Patients with a left ventricular ejection fraction of less than 25% as determined by transthoracic echocardiography. - Patients with physical findings consistent with ongoing uncontrolled CHF. - Myocardial infarction within 30 days of treatment. - Successful coronary revascularization procedures within 3 months of study enrollment. - Documented stroke or transient ischemic attack (TIA) within 60 days of study enrollment. - History of severe aortic stenosis or insufficiency; severe mitral stenosis; or severe mitral insufficiency. - Severe co-morbidity associated with a reduction in life expectancy of less than 1 year. - Subjects with PT, PTT or platelet counts greater than the upper limit of normal and those with a hematocrit <35%. - Subjects with uncontrolled hypertension. - Currently enrolled in another investigational device or drug trial (IDE or IND) that has not completed the required follow-up period. - History of alcohol or drug abuse within 3 months of screening. - Joint or peripheral vascular disease that severely limits treadmill walking. - Chronic obstructive pulmonary disease that severely limits walking or FEV1.0<30% predicted. - Subjects who are pregnant or lactating. - Males and females who are capable of reproduction and will not take acceptable measures to prevent reproduction during the study. - Subjects who test positive for HIV, hepatitis B or hepatitis C, have a chronic inflammatory disease, autoimmune disease or are on chronic immunosuppressive medications. - Subjects with a known hypersensitivity to E. coli-derived proteins. - Subjects with evidence (clinical, laboratory, or imaging) of cancer recurrence within the past 5 years (other than non-melanoma skin cancer or in situ cervical carcinoma).
Sponsor: Losordo, Douglas, M.D.
Phase: Phase 1
Trial ID: NCT00081913
Not Accepting Healthy Volunteers