Safety and Feasibility Trial of Adipose-Derived Regenerative Cells in the Treatment of Chronic Myocardial Ischemia
- Conditions
- Myocardial Ischemia
- Interventions
- Device: ADRCs processed by the Celution System
- Registration Number
- NCT01556022
- Lead Sponsor
- Cytori Therapeutics
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
- Males or females 20-80 years of age
- Significant multi-vessel coronary artery disease not amenable to percutaneous or surgical revascularization in the target area
- CCS Angina Functional Class II-IV and/or NYHA Stages of Heart Failure Class II or III
- On maximal medical therapy for anginal symptoms and or heart failure symptoms
- Hemodynamic stability (Systolic Blood Pressure ≥ 90 mm/Hg, Heart Rate < 110; Pulse-Oxygen > 95)
- Ejection fraction ≤ 45
- 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
- Atrial fibrillation or flutter without a pace maker that guarantees a stable heart rate
- Unstable angina
- LV thrombus, as documented by echocardiography
- Planned staged treatment of CAD or other intervention on the heart
- Platelet count < 100,000/mm3
- WBC < 2,000/mm3
- TIA or stroke within 90 days prior to randomization
- ICD shock within 30 days of randomization
- Any condition requiring immunosuppressive medication
- A high-risk acute coronary syndrome (ACS) or a myocardial infarction within 60 days prior to randomization
- Revascularization within 60 days prior to randomization
- Inability to walk on a treadmill except for class IV angina patients who will be evaluated separately
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ADRCs processed by the Celution System ADRCs processed by the Celution System 400,000 adipose-derived regenerative cells (ADRCs) per kilogram (kg) of body weight not to exceed 40,000,000 cells.
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (8)
Cardiology, P.C.
🇺🇸Birmingham, Alabama, United States
Scripps Clinic - Torrey Pines, Scripps Green Hospital
🇺🇸La Jolla, California, United States
Florida Hospital-Pepin Heart Institute
🇺🇸Tampa, Florida, United States
Minneapolis Heart Institute Foundation
🇺🇸Minneapolis, Minnesota, United States
Texas Heart Institute
🇺🇸Houston, Texas, United States
University of Utah Health Care
🇺🇸Salt Lake City, Utah, United States
University of Florida
🇺🇸Gainesville, Florida, United States
Duke University Hospital
🇺🇸Durham, North Carolina, United States