Recruitment

Recruitment Status
Completed
Estimated Enrollment
45

Inclusion Criteria

Ejection fraction ≥ 20% and ≤ 45%
Hemodynamic stability (SBP ≥ 90 mm/Hg, HR <110)
Inducible ischemia using an objective assessment of ischemia within 1 year of screening (i.e. exercise ECG changes, SPECT)
...
Ejection fraction ≥ 20% and ≤ 45%
Hemodynamic stability (SBP ≥ 90 mm/Hg, HR <110)
Inducible ischemia using an objective assessment of ischemia within 1 year of screening (i.e. exercise ECG changes, SPECT)
On maximal medical therapy for anginal symptoms and/or heart failure symptoms
CCS Angina Functional Class II-IV and/or NYHA Stages of Heart Failure Class II or III
Males or females > 20 and < 80 years of age
Left ventricular wall thickness ≥ 8 mm at the target site for cell injection
Significant multi-vessel coronary artery disease not amenable to percutaneous or surgical revascularization

Exclusion Criteria

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
TIA or stroke within 90 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
TIA or stroke within 90 days prior to randomization
Atrial fibrillation or flutter without a pace maker that guarantees a stable heart rate
WBC < 2,000/mm3
Hemoglobin ≤ 10.0 g/dL
A high-risk acute coronary syndrome (ACS) or a myocardial infarction in the 60 days prior to randomization
Planned staged treatment of CAD or other intervention on the heart
LV thrombus, as documented by echocardiography
ICD shock within 30 days prior to randomization
Platelet count < 100,000/mm3
Any condition requiring immunosuppressive medication
Unstable angina
Revascularization within 60 days prior to randomization

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)
Inducible ischemia using an objective assessment of ischemia within 1 year of screening (i.e. exercise ECG changes, SPECT)
...
Ejection fraction ≥ 20% and ≤ 45%
Hemodynamic stability (SBP ≥ 90 mm/Hg, HR <110)
Inducible ischemia using an objective assessment of ischemia within 1 year of screening (i.e. exercise ECG changes, SPECT)
On maximal medical therapy for anginal symptoms and/or heart failure symptoms
CCS Angina Functional Class II-IV and/or NYHA Stages of Heart Failure Class II or III
Males or females > 20 and < 80 years of age
Left ventricular wall thickness ≥ 8 mm at the target site for cell injection
Significant multi-vessel coronary artery disease not amenable to percutaneous or surgical revascularization

Exclusion Criteria

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
TIA or stroke within 90 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
TIA or stroke within 90 days prior to randomization
Atrial fibrillation or flutter without a pace maker that guarantees a stable heart rate
WBC < 2,000/mm3
Hemoglobin ≤ 10.0 g/dL
A high-risk acute coronary syndrome (ACS) or a myocardial infarction in the 60 days prior to randomization
Planned staged treatment of CAD or other intervention on the heart
LV thrombus, as documented by echocardiography
ICD shock within 30 days prior to randomization
Platelet count < 100,000/mm3
Any condition requiring immunosuppressive medication
Unstable angina
Revascularization within 60 days prior to randomization

Locations

Cleveland, Ohio, 11100
Cleveland, Ohio, 11100

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