Clinical trial NCT02052427: Safety & Efficacy of Adipose-Derived Regenerative Cells in the Treatment of Chronic Myocardial Ischemia (ATHENA II)
Official title: Adipose-derived Regenerative Cells in the Treatment of Patients With Chronic Ischemic Heart Disease Not Amenable to Surgical or Interventional Revascularization II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Myocardial Ischemia
Keywords: Ischemic heart disease
Coronary artery disease
Chronic Heart Failure
Cardiovascular disease
adult stem cells
adipose derived regenerative cells
Lead sponsor: Cytori Therapeutics
Sponsor class: INDUSTRY
First posted: 2014-02-03
Enrollment: 3
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Primary Efficacy - Change in Minnesota Living with Heart Failure Questionnaire
timeFrame: 6 months post treatment
Secondary outcomes:
measure: Secondary Efficacy - Change in mVO2
timeFrame: 6 months post treatment
measure: Secondary Efficacy - Change in LVESV/LVEDV
timeFrame: 6 months post treatment
measure: Secondary Efficacy - Change in Ejection Fraction
timeFrame: 6 months post treatment
measure: Secondary Efficacy - Change in perfusion defect
timeFrame: 6 months post treatment
measure: Secondary Efficacy - Resource Utilization
timeFrame: through 12 months post treatment
measure: Secondary Efficacy - Change in heart failure symptoms, angina, and quality of life
timeFrame: through 12 months post treatment
Other outcomes:
measure: Safety - Number of Patients Experiencing Treatment Emergent SAEs
timeFrame: Treatment through 12 months
measure: Safety - Number of Patients Experiencing Arrhythmias Assessed via Holter monitor
timeFrame: Screening through 3 months post treatment
measure: Safety - Number of patients that experience a MACE
timeFrame: Treatment through 12 months
Locations:
city: Cleveland
country: United States
facility: University Hospital Case Medical Center
state: Ohio
Study officials:
affiliation: The Stem Cell Center at Texas Heart Institute
name: Emerson C. Perin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cedars-Sinai Medical Center
name: Timothy Henry, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Henry TD, Pepine CJ, Lambert CR, Traverse JH, Schatz R, Costa M, Povsic TJ, David Anderson R, Willerson JT, Kesten S, Perin EC. The Athena trials: Autologous adipose-derived regenerative cells for refractory chronic myocardial ischemia with left ventricular dysfunction. Catheter Cardiovasc Interv. 2017 Feb 1;89(2):169-177. doi: 10.1002/ccd.26601. Epub 2016 Sep 23.