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
- Males or females > 20 and < 80 years of age
- CCS Angina Functional Class II-IV and/or NYHA Stages of Heart Failure Class II or III
- Hemodynamic stability (SBP ≥ 90 mm/Hg, HR <110)
- ...
- Males or females > 20 and < 80 years of age
- CCS Angina Functional Class II-IV and/or NYHA Stages of Heart Failure Class II or III
- Hemodynamic stability (SBP ≥ 90 mm/Hg, HR <110)
- On maximal medical therapy for anginal symptoms and/or heart failure symptoms
- Significant multi-vessel coronary artery disease not amenable to percutaneous or surgical revascularization
- Inducible ischemia using an objective assessment of ischemia within 1 year of screening (i.e. exercise ECG changes, SPECT)
- Ejection fraction ≥ 20% and ≤ 45%
- Left ventricular wall thickness ≥ 8 mm at the target site for cell injection
Exclusion Criteria
- Revascularization within 60 days prior to randomization
- Unstable angina
- WBC < 2,000/mm3
- ...
- Revascularization within 60 days prior to randomization
- Unstable angina
- WBC < 2,000/mm3
- Any condition requiring immunosuppressive medication
- TIA or stroke within 90 days prior to randomization
- ICD shock within 30 days prior to randomization
- Atrial fibrillation or flutter without a pace maker that guarantees a stable heart rate
- Inability to walk on a treadmill except for class IV angina patients who will be evaluated separately
- Platelet count < 100,000/mm3
- A high-risk acute coronary syndrome (ACS) or a myocardial infarction in the 60 days prior to randomization
- Hemoglobin ≤ 10.0 g/dL
- Planned staged treatment of CAD or other intervention on the heart
- LV thrombus, as documented by echocardiography
- Hepatic dysfunction, as defined as aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 1.5 times the upper limit of normal range (x ULN)
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
- Males or females > 20 and < 80 years of age
- CCS Angina Functional Class II-IV and/or NYHA Stages of Heart Failure Class II or III
- Hemodynamic stability (SBP ≥ 90 mm/Hg, HR <110)
- ...
- Males or females > 20 and < 80 years of age
- CCS Angina Functional Class II-IV and/or NYHA Stages of Heart Failure Class II or III
- Hemodynamic stability (SBP ≥ 90 mm/Hg, HR <110)
- On maximal medical therapy for anginal symptoms and/or heart failure symptoms
- Significant multi-vessel coronary artery disease not amenable to percutaneous or surgical revascularization
- Inducible ischemia using an objective assessment of ischemia within 1 year of screening (i.e. exercise ECG changes, SPECT)
- Ejection fraction ≥ 20% and ≤ 45%
- Left ventricular wall thickness ≥ 8 mm at the target site for cell injection
Exclusion Criteria
- Revascularization within 60 days prior to randomization
- Unstable angina
- WBC < 2,000/mm3
- ...
- Revascularization within 60 days prior to randomization
- Unstable angina
- WBC < 2,000/mm3
- Any condition requiring immunosuppressive medication
- TIA or stroke within 90 days prior to randomization
- ICD shock within 30 days prior to randomization
- Atrial fibrillation or flutter without a pace maker that guarantees a stable heart rate
- Inability to walk on a treadmill except for class IV angina patients who will be evaluated separately
- Platelet count < 100,000/mm3
- A high-risk acute coronary syndrome (ACS) or a myocardial infarction in the 60 days prior to randomization
- Hemoglobin ≤ 10.0 g/dL
- Planned staged treatment of CAD or other intervention on the heart
- LV thrombus, as documented by echocardiography
- Hepatic dysfunction, as defined as aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 1.5 times the upper limit of normal range (x ULN)
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