Myocardial Ischemia
Conditions
Keywords
Ischemic heart disease, Coronary artery disease, Chronic heart failure, Cardiovascular disease, Adult stem cells, Adipose derived regenerative cells
Brief summary
This is a prospective, randomized, placebo-controlled, double blind safety and feasibility clinical trial.
Detailed description
To assess the safety and feasibility of Adipose-Derived Regenerative Cells (ADRCs) delivered via an intramyocardial route in the treatment of chronic ischemic heart disease in patients who are not eligible for percutaneous or surgical revascularization.
Interventions
DEVICEADRCs processed by the Celution System
Subjects will undergo liposuction under anesthesia. Lipoaspirate will be processed in the Celution System to isolate and concentrate ADRCs. When randomized to ADRCs, intramyocardial injections of ADRCs will be administered via the MYOSTAR injection catheter.
DEVICEPlacebo Comparator: Lactated Ringer's and Subject's Blood
Subjects will undergo liposuction under anesthesia. Lipoaspirate will be processed in the Celution System to isolate and concentrate ADRCs. When randomized to Placebo, intramyocardial injections of Placebo will be administered via the MYOSTAR injection catheter.
Sponsors
Cytori Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Males or females 20-80 years of age 2. Significant multi-vessel coronary artery disease not amenable to percutaneous or surgical revascularization in the target area 3. CCS Angina Functional Class II-IV and/or NYHA Stages of Heart Failure Class II or III 4. On maximal medical therapy for anginal symptoms and or heart failure symptoms 5. Hemodynamic stability (Systolic Blood Pressure ≥ 90 mm/Hg, Heart Rate \< 110; Pulse-Oxygen \> 95) 6. Ejection fraction ≤ 45 7. Left ventricular wall thickness ≥ 8 mm at the target site for cell injection, confirmed by 2D contrast echo within 4 weeks prior to enrollment, free of thrombus Key
Exclusion criteria
1. Atrial fibrillation or flutter without a pace maker that guarantees a stable heart rate 2. Unstable angina 3. LV thrombus, as documented by echocardiography 4. Planned staged treatment of CAD or other intervention on the heart 5. Platelet count \< 100,000/mm3 6. WBC \< 2,000/mm3 7. TIA or stroke within 90 days prior to randomization 8. ICD shock within 30 days of randomization 9. Any condition requiring immunosuppressive medication 10. A high-risk acute coronary syndrome (ACS) or a myocardial infarction within 60 days prior to randomization 11. Revascularization within 60 days prior to randomization 12. Inability to walk on a treadmill except for class IV angina patients who will be evaluated separately 13. Hepatic dysfunction, as defined as aspartate aminotransferase (AST) and /or alanine aminotransferase (ALT) \> 1.5 times the upper limit of normal range (x ULN) prior to randomization
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment emergent serious adverse events (SAEs), major adverse cardiac events (MACE), arrhythmia assessment, change in cardiac function and symptoms, and resource utilization | 6 and 12 Months | Safety endpoints include: 1. Treatment emergent SAEs 2. Arrhythmia assessment via Holter monitoring 3. MACE defined as cardiac death and hospitalization for heart failure Feasibility endpoints include: 1. Change in mVO2 at 6 months 2. Change in LVESV/LVEDV at 6 months 3. Change in ejection fraction at 6 months 4. Change in perfusion defect at 6 months 5. Resource utilization 6. Change in heart failure symptoms, angina, and quality of life through 12 months |
Countries
United States
Outcome results
None listed