Safety and Feasibility Trial of Adipose-Derived Regenerative Cells in the Treatment of Chronic Myocardial Ischemia (ATHENA)
Primary Purpose
Myocardial Ischemia
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ADRCs processed by the Celution System
Placebo Comparator: Lactated Ringer's and Subject's Blood
Sponsored by
About this trial
This is an interventional treatment trial for Myocardial Ischemia focused on measuring Ischemic heart disease, Coronary artery disease, Chronic heart failure, Cardiovascular disease, Adult stem cells, Adipose derived regenerative cells
Eligibility Criteria
Key Inclusion Criteria:
- Males or females 20-80 years of age
- Significant multi-vessel coronary artery disease not amenable to percutaneous or surgical revascularization in the target area
- 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 (Systolic Blood Pressure ≥ 90 mm/Hg, Heart Rate < 110; Pulse-Oxygen > 95)
- Ejection fraction ≤ 45
- Left ventricular wall thickness ≥ 8 mm at the target site for cell injection, confirmed by 2D contrast echo within 4 weeks prior to enrollment, free of thrombus
Key Exclusion Criteria:
- 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 of randomization
- Any condition requiring immunosuppressive medication
- A high-risk acute coronary syndrome (ACS) or a myocardial infarction within 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) prior to randomization
Sites / Locations
- Cardiology, P.C.
- Scripps Clinic - Torrey Pines, Scripps Green Hospital
- University of Florida
- Florida Hospital-Pepin Heart Institute
- Minneapolis Heart Institute Foundation
- Duke University Hospital
- Texas Heart Institute
- University of Utah Health Care
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
ADRCs processed by the Celution System
Lactated Ringers and Subject's blood
Arm Description
400,000 adipose-derived regenerative cells (ADRCs) per kilogram (kg) of body weight not to exceed 40,000,000 cells.
Sterile Lactated Ringers Solution (3mL) mixed with ≤ 0.10 ml of the study Subject's own freshly drawn blood.
Outcomes
Primary Outcome Measures
Treatment emergent serious adverse events (SAEs), major adverse cardiac events (MACE), arrhythmia assessment, change in cardiac function and symptoms, and resource utilization
Safety endpoints include:
Treatment emergent SAEs
Arrhythmia assessment via Holter monitoring
MACE defined as cardiac death and hospitalization for heart failure
Feasibility endpoints include:
Change in mVO2 at 6 months
Change in LVESV/LVEDV at 6 months
Change in ejection fraction at 6 months
Change in perfusion defect at 6 months
Resource utilization
Change in heart failure symptoms, angina, and quality of life through 12 months
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01556022
Brief Title
Safety and Feasibility Trial of Adipose-Derived Regenerative Cells in the Treatment of Chronic Myocardial Ischemia
Acronym
ATHENA
Official Title
Adipose-derived Regenerative Cells in the Treatment of Patients With Chronic Ischemic Heart Disease Not Amenable to Surgical or Interventional Revascularization.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cytori Therapeutics
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a prospective, randomized, placebo-controlled, double blind safety and feasibility clinical trial.
Detailed Description
To assess the safety and feasibility 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Ischemia
Keywords
Ischemic heart disease, Coronary artery disease, Chronic heart failure, Cardiovascular disease, Adult stem cells, Adipose derived regenerative cells
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ADRCs processed by the Celution System
Arm Type
Experimental
Arm Description
400,000 adipose-derived regenerative cells (ADRCs) per kilogram (kg) of body weight not to exceed 40,000,000 cells.
Arm Title
Lactated Ringers and Subject's blood
Arm Type
Placebo Comparator
Arm Description
Sterile Lactated Ringers Solution (3mL) mixed with ≤ 0.10 ml of the study Subject's own freshly drawn blood.
Intervention Type
Device
Intervention Name(s)
ADRCs processed by the Celution System
Other Intervention Name(s)
ADRCs, Intramyocardial injections
Intervention Description
Subjects will undergo liposuction under anesthesia. Lipoaspirate will be processed in the Celution System to isolate and concentrate ADRCs. When randomized to ADRCs, intramyocardial injections of ADRCs will be administered via the MYOSTAR injection catheter.
Intervention Type
Device
Intervention Name(s)
Placebo Comparator: Lactated Ringer's and Subject's Blood
Other Intervention Name(s)
Placebo
Intervention Description
Subjects will undergo liposuction under anesthesia. Lipoaspirate will be processed in the Celution System to isolate and concentrate ADRCs. When randomized to Placebo, intramyocardial injections of Placebo will be administered via the MYOSTAR injection catheter.
Primary Outcome Measure Information:
Title
Treatment emergent serious adverse events (SAEs), major adverse cardiac events (MACE), arrhythmia assessment, change in cardiac function and symptoms, and resource utilization
Description
Safety endpoints include:
Treatment emergent SAEs
Arrhythmia assessment via Holter monitoring
MACE defined as cardiac death and hospitalization for heart failure
Feasibility endpoints include:
Change in mVO2 at 6 months
Change in LVESV/LVEDV at 6 months
Change in ejection fraction at 6 months
Change in perfusion defect at 6 months
Resource utilization
Change in heart failure symptoms, angina, and quality of life through 12 months
Time Frame
6 and 12 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Males or females 20-80 years of age
Significant multi-vessel coronary artery disease not amenable to percutaneous or surgical revascularization in the target area
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 (Systolic Blood Pressure ≥ 90 mm/Hg, Heart Rate < 110; Pulse-Oxygen > 95)
Ejection fraction ≤ 45
Left ventricular wall thickness ≥ 8 mm at the target site for cell injection, confirmed by 2D contrast echo within 4 weeks prior to enrollment, free of thrombus
Key Exclusion Criteria:
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 of randomization
Any condition requiring immunosuppressive medication
A high-risk acute coronary syndrome (ACS) or a myocardial infarction within 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) prior to randomization
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emerson Perin, MD, PhD
Organizational Affiliation
Texas Heart Institute, Houston, TX
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Timothy Henry, MD
Organizational Affiliation
Minneapolis Heart Institute Foundation, Minneapolis, MN
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiology, P.C.
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35211
Country
United States
Facility Name
Scripps Clinic - Torrey Pines, Scripps Green Hospital
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Florida Hospital-Pepin Heart Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Minneapolis Heart Institute Foundation
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Duke University Hospital
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Texas Heart Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Utah Health Care
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
27148802
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.
Results Reference
result
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Safety and Feasibility Trial of Adipose-Derived Regenerative Cells in the Treatment of Chronic Myocardial Ischemia
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