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 efficacy clinical trial.
Detailed description
To assess the safety and efficacy 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
DEVICECelution System
ADRCs processed by the Celution System for reintroduction into the myocardium
DEVICEPlacebo
Physiological solution made of Lactated Ringers solution and a small amount (\<1mL) of autologous blood
Sponsors
Cytori Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Males or females \> 20 and \< 80 years of age 2. Significant multi-vessel coronary artery disease not amenable to percutaneous or surgical revascularization 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 (SBP ≥ 90 mm/Hg, HR \<110) 6. Ejection fraction ≥ 20% and ≤ 45% 7. Inducible ischemia using an objective assessment of ischemia within 1 year of screening (i.e. exercise ECG changes, SPECT) 8. Left ventricular wall thickness ≥ 8 mm at the target site for cell injection
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 prior to randomization 9. Any condition requiring immunosuppressive medication 10. A high-risk acute coronary syndrome (ACS) or a myocardial infarction in the 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) 14. Hemoglobin ≤ 10.0 g/dL
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Efficacy - Change in Minnesota Living with Heart Failure Questionnaire | 6 months post treatment | Change in Minnesota Living with Heart Failure Questionnaire prior to treatment and at 6 months post treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Efficacy - Change in Ejection Fraction | 6 months post treatment | Change in Ejection Fraction (%) at 6 months assessed by 2D Contrast Echocardiography |
| Secondary Efficacy - Change in perfusion defect | 6 months post treatment | Change in perfusion defect at 6 months assessed by Rest/Pharmacologic Stress SPECT |
| Secondary Efficacy - Resource Utilization | through 12 months post treatment | Resource utilization - hospital length of stay, re-hospitalization for cardiac related events |
| Secondary Efficacy - Change in heart failure symptoms, angina, and quality of life | through 12 months post treatment | Change in heart failure symptoms, angina, and quality of life assessed by - NYHA classification, CCS classification, MLHFQ (other than 6 months) |
| Secondary Efficacy - Change in mVO2 | 6 months post treatment | Change in mVO2 at 6 months as assessed by Exercise Tolerance Test |
| Secondary Efficacy - Change in LVESV/LVEDV | 6 months post treatment | Change in LVESV/LVEDV at 6 months as assessed by Echocardiography |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety - Number of patients that experience a MACE | Treatment through 12 months | Number of patients that experience a Major Adverse Cardiac Event (MACE) |
| Safety - Number of Patients Experiencing Treatment Emergent SAEs | Treatment through 12 months | — |
| Safety - Number of Patients Experiencing Arrhythmias Assessed via Holter monitor | Screening through 3 months post treatment | — |
Countries
United States
Outcome results
None listed