REgenerative CardiOsphere iNjection to STRengthen dysfUnCTional Hearts
Status: | Completed |
---|---|
Conditions: | Peripheral Vascular Disease, Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/1/2014 |
Start Date: | July 2012 |
End Date: | September 2014 |
Contact: | Tracey S. Gerez, BS, MA, CCRP |
Email: | tracey.gerez@cshs.org |
Phone: | 310.423.1231 |
A double blinded and placebo-controlled, dose escalation, single-center safety and
preliminary efficacy study of cardiospheres delivered via NOGA MYOSTAR injection catheter in
subjects with chronic ischemic cardiomyopathy. The objective is to achieve and document
myocardial regeneration in patients with chronic scar.
preliminary efficacy study of cardiospheres delivered via NOGA MYOSTAR injection catheter in
subjects with chronic ischemic cardiomyopathy. The objective is to achieve and document
myocardial regeneration in patients with chronic scar.
Inclusion Criteria:
- Adults with ischemic cardiomyopathy (EF >10 and <40% by functional imaging [ECHO, CT,
MRI, contrast ventriculography])
- Symptomatic heart failure of NYHA Class 2 or 3
- History of prior remote (>3 mo) myocardial infarction and/or documented obstructive
coronary artery disease with corresponding dysfunctional segments by functional
imaging
- Age > 18 years
- Ability to provide informed consent and follow-up with protocol procedures
Exclusion Criteria:
- Documented myocardial infarction within 3 months (120 days)
- Known or suspected left ventricular thrombus
- Non-cardiovascular disease with life expectancy of < 3 years
- Absence of significant gadolinium-enhanced scar (>10% of LV mass) at baseline MRIc
- Positive panel-reactive antibodies (PRA)
- Need for further revascularization clinically indicated at the time the patient is
assessed for participation in the clinical trial. This will be determined by a
cardiologist who is not an investigator in the clinical trial. No further
revascularization may be indicated by no arteries with significant stenosis, the
location, and extent of any stenosis may not be suitable for angioplasty, the distal
vessels may not be suitable for placement of bypass grafts, and/or the patient
declines angioplasty or bypass surgery.
- NYHA IV heart failure
- History of aortic stenosis/insufficiency
- Requirement for chronic immunosuppressive therapy
- Participation in an on-going protocol studying an experimental drug or device
- Diagnosis of congenital or genetically-transmitted cardiomyopathy
- Current alcohol or drug abuse because of anticipated difficulty in complying with
protocol-related procedures
- Pregnancy or child-bearing potential without use of effective contraception. Men
intending to "father" children are also excluded.
- Human Immunodeficiency virus infection
- Viral hepatitis
- Uncontrolled diabetes and/or hemoglobin A1C > 8.5%
- Abnormal liver function (SGPT > 3 times the upper reference range) and/or hematology
(hematocrit <25%, WBC <3000, Platelets <100,000) studies without a reversible,
identifiable cause
- Ventricular tachycardia or fibrillation not associated with an acute ischemic episode
- Canadian Cardiovascular Society Angina Class 3 or 4
- History of cardiac tumor or cardiac tumor demonstrated or suspected on MRI other
imaging modality
- Previous stem cell therapy/treatment
- Individuals who are not fluent in English
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