Safety & Efficacy of Adipose-Derived Regenerative Cells in the Treatment of Chronic Myocardial Ischemia (ATHENA II)
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
- Estimated Enrollment
- 45
Inclusion Criteria
- Ejection fraction ≥ 20% and ≤ 45%
- Hemodynamic stability (SBP ≥ 90 mm/Hg, HR <110)
- On maximal medical therapy for anginal symptoms and/or heart failure symptoms
- ...
- Ejection fraction ≥ 20% and ≤ 45%
- Hemodynamic stability (SBP ≥ 90 mm/Hg, HR <110)
- On maximal medical therapy for anginal symptoms and/or heart failure symptoms
- Inducible ischemia using an objective assessment of ischemia within 1 year of screening (i.e. exercise ECG changes, SPECT)
- Left ventricular wall thickness ≥ 8 mm at the target site for cell injection
- CCS Angina Functional Class II-IV and/or NYHA Stages of Heart Failure Class II or III
- Significant multi-vessel coronary artery disease not amenable to percutaneous or surgical revascularization
- Males or females > 20 and < 80 years of age
Exclusion Criteria
- ICD shock within 30 days prior to randomization
- Hemoglobin ≤ 10.0 g/dL
- TIA or stroke within 90 days prior to randomization
- ...
- ICD shock within 30 days prior to randomization
- Hemoglobin ≤ 10.0 g/dL
- TIA or stroke within 90 days prior to randomization
- Any condition requiring immunosuppressive medication
- A high-risk acute coronary syndrome (ACS) or a myocardial infarction in the 60 days prior to randomization
- WBC < 2,000/mm3
- Atrial fibrillation or flutter without a pace maker that guarantees a stable heart rate
- Unstable angina
- LV thrombus, as documented by echocardiography
- Revascularization within 60 days prior to randomization
- Hepatic dysfunction, as defined as aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 1.5 times the upper limit of normal range (x ULN)
- Inability to walk on a treadmill except for class IV angina patients who will be evaluated separately
- Platelet count < 100,000/mm3
- Planned staged treatment of CAD or other intervention on the heart
Summary
- Conditions
- Myocardial Ischemia
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
Participation Requirements
- Age
- Between 20 years and 80 years
- Gender
- Both males and females
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.
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.
Inclusion Criteria
- Ejection fraction ≥ 20% and ≤ 45%
- Hemodynamic stability (SBP ≥ 90 mm/Hg, HR <110)
- On maximal medical therapy for anginal symptoms and/or heart failure symptoms
- ...
- Ejection fraction ≥ 20% and ≤ 45%
- Hemodynamic stability (SBP ≥ 90 mm/Hg, HR <110)
- On maximal medical therapy for anginal symptoms and/or heart failure symptoms
- Inducible ischemia using an objective assessment of ischemia within 1 year of screening (i.e. exercise ECG changes, SPECT)
- Left ventricular wall thickness ≥ 8 mm at the target site for cell injection
- CCS Angina Functional Class II-IV and/or NYHA Stages of Heart Failure Class II or III
- Significant multi-vessel coronary artery disease not amenable to percutaneous or surgical revascularization
- Males or females > 20 and < 80 years of age
Exclusion Criteria
- ICD shock within 30 days prior to randomization
- Hemoglobin ≤ 10.0 g/dL
- TIA or stroke within 90 days prior to randomization
- ...
- ICD shock within 30 days prior to randomization
- Hemoglobin ≤ 10.0 g/dL
- TIA or stroke within 90 days prior to randomization
- Any condition requiring immunosuppressive medication
- A high-risk acute coronary syndrome (ACS) or a myocardial infarction in the 60 days prior to randomization
- WBC < 2,000/mm3
- Atrial fibrillation or flutter without a pace maker that guarantees a stable heart rate
- Unstable angina
- LV thrombus, as documented by echocardiography
- Revascularization within 60 days prior to randomization
- Hepatic dysfunction, as defined as aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 1.5 times the upper limit of normal range (x ULN)
- Inability to walk on a treadmill except for class IV angina patients who will be evaluated separately
- Platelet count < 100,000/mm3
- Planned staged treatment of CAD or other intervention on the heart
Tracking Information
- NCT #
- NCT02052427
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Emerson C. Perin, MD, PhD The Stem Cell Center at Texas Heart Institute Principal Investigator: Timothy Henry, MD Cedars-Sinai Medical Center
- Emerson C. Perin, MD, PhD The Stem Cell Center at Texas Heart Institute Principal Investigator: Timothy Henry, MD Cedars-Sinai Medical Center