Safety & Efficacy of Adipose-Derived Regenerative Cells in the Treatment of Chronic Myocardial Ischemia (ATHENA II)
ATHENA II
Adipose-derived Regenerative Cells in the Treatment of Patients With Chronic Ischemic Heart Disease Not Amenable to Surgical or Interventional Revascularization II
1 other identifier
interventional
3
1 country
1
Brief Summary
This is a prospective, randomized, placebo-controlled, double blind safety and efficacy clinical trial.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jan 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 30, 2014
CompletedFirst Posted
Study publicly available on registry
February 3, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedOctober 28, 2016
October 1, 2016
1.6 years
January 30, 2014
October 26, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary Efficacy - Change in Minnesota Living with Heart Failure Questionnaire
Change in Minnesota Living with Heart Failure Questionnaire prior to treatment and at 6 months post treatment.
6 months post treatment
Secondary Outcomes (6)
Secondary Efficacy - Change in mVO2
6 months post treatment
Secondary Efficacy - Change in LVESV/LVEDV
6 months post treatment
Secondary Efficacy - Change in Ejection Fraction
6 months post treatment
Secondary Efficacy - Change in perfusion defect
6 months post treatment
Secondary Efficacy - Resource Utilization
through 12 months post treatment
- +1 more secondary outcomes
Other Outcomes (3)
Safety - Number of Patients Experiencing Treatment Emergent SAEs
Treatment through 12 months
Safety - Number of Patients Experiencing Arrhythmias Assessed via Holter monitor
Screening through 3 months post treatment
Safety - Number of patients that experience a MACE
Treatment through 12 months
Study Arms (2)
ADRCs
EXPERIMENTALAdipose-Derived Regenerative Cells (ADRCs) processed by the Celution System: * 0.8 x 10\^6 cells/kg body weight (not to exceed 80.0 x 10\^6 cells) * Delivered via the MYOSTAR™ Injection Catheter in 15 intramyocardial injections
Placebo
PLACEBO COMPARATORPlacebo - Physiological Solution * Inactive substance (Lactated Ringers + autologous blood) * Delivered via the MYOSTAR™ Injection Catheter in 15 intramyocardial injections
Interventions
ADRCs processed by the Celution System for reintroduction into the myocardium
Physiological solution made of Lactated Ringers solution and a small amount (\<1mL) of autologous blood
Eligibility Criteria
You may qualify if:
- Males or females \> 20 and \< 80 years of age
- Significant multi-vessel coronary artery disease not amenable to percutaneous or surgical revascularization
- 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 (SBP ≥ 90 mm/Hg, HR \<110)
- Ejection fraction ≥ 20% and ≤ 45%
- 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
You may not qualify if:
- 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 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
- 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)
- Hemoglobin ≤ 10.0 g/dL
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Case Medical Center
Cleveland, Ohio, 11100, United States
Related Publications (1)
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.
PMID: 27148802RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Emerson C. Perin, MD, PhD
The Stem Cell Center at Texas Heart Institute
- PRINCIPAL INVESTIGATOR
Timothy Henry, MD
Cedars-Sinai Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 30, 2014
First Posted
February 3, 2014
Study Start
January 1, 2014
Primary Completion
August 1, 2015
Study Completion
October 1, 2016
Last Updated
October 28, 2016
Record last verified: 2016-10