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Safety and Feasibility Trial of Adipose-Derived Regenerative Cells in the Treatment of Chronic Myocardial Ischemia (ATHENA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01556022
Recruitment Status : Completed
First Posted : March 16, 2012
Last Update Posted : October 28, 2016
Sponsor:
Information provided by (Responsible Party):
Cytori Therapeutics

Tracking Information
First Submitted Date  ICMJE March 14, 2012
First Posted Date  ICMJE March 16, 2012
Last Update Posted Date October 28, 2016
Study Start Date  ICMJE June 2012
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 23, 2012)
Treatment emergent serious adverse events (SAEs), major adverse cardiac events (MACE), arrhythmia assessment, change in cardiac function and symptoms, and resource utilization [ Time Frame: 6 and 12 Months ]
Safety endpoints include:
  1. Treatment emergent SAEs
  2. Arrhythmia assessment via Holter monitoring
  3. MACE defined as cardiac death and hospitalization for heart failure
Feasibility endpoints include:
  1. Change in mVO2 at 6 months
  2. Change in LVESV/LVEDV at 6 months
  3. Change in ejection fraction at 6 months
  4. Change in perfusion defect at 6 months
  5. Resource utilization
  6. Change in heart failure symptoms, angina, and quality of life through 12 months
Original Primary Outcome Measures  ICMJE
 (submitted: March 15, 2012)
Treatment emergent serious adverse events (SAEs),major adverse cardiac events (MACE) and Arrhythmia Assessment [ Time Frame: 12 Months ]
Safety endoints include:
  1. Treatment emergent SAEs
  2. Arrhythmia assessment via Holter monitoring
  3. MACE defined as
    • Cardiac death
    • Hospitalization for Heart Failure defined as:
      • ¬> 24 hr stay with administration of IV diuretics
      • Respiratory failure requiring intubation
      • Ventricular fibrillation requiring resuscitation
      • Application of an intra-aortic balloon pump (IABP)
      • Hypo-perfusion requiring inotropic therapy
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2012)
Change in Cardiac Function [ Time Frame: 6 and 12 months ]
  1. Change in mV02 assessed by Exercise Tolerance Test (ETT) at 6 months compared to baseline
  2. Change in LVESV/LVEDV, perfusion and ejection fraction (EF) at 6 months compared to baseline
  3. Change in heart failure symptoms, angina and quality of life (QOL) through 12 months
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Feasibility Trial of Adipose-Derived Regenerative Cells in the Treatment of Chronic Myocardial Ischemia
Official Title  ICMJE Adipose-derived Regenerative Cells in the Treatment of Patients With Chronic Ischemic Heart Disease Not Amenable to Surgical or Interventional Revascularization.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Myocardial Ischemia
Intervention  ICMJE
  • Device: ADRCs processed by the Celution System
    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.
    Other Names:
    • ADRCs
    • Intramyocardial injections
  • Device: Placebo Comparator: Lactated Ringer's and Subject's Blood
    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.
    Other Name: Placebo
Study Arms  ICMJE
  • Experimental: ADRCs processed by the Celution System
    400,000 adipose-derived regenerative cells (ADRCs) per kilogram (kg) of body weight not to exceed 40,000,000 cells.
    Intervention: Device: ADRCs processed by the Celution System
  • Placebo Comparator: Lactated Ringers and Subject's blood
    Sterile Lactated Ringers Solution (3mL) mixed with ≤ 0.10 ml of the study Subject's own freshly drawn blood.
    Intervention: Device: Placebo Comparator: Lactated Ringer's and Subject's Blood
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 19, 2014)
28
Original Estimated Enrollment  ICMJE
 (submitted: March 15, 2012)
45
Actual Study Completion Date  ICMJE October 2016
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  1. Males or females 20-80 years of age
  2. Significant multi-vessel coronary artery disease not amenable to percutaneous or surgical revascularization in the target area
  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 (Systolic Blood Pressure ≥ 90 mm/Hg, Heart Rate < 110; Pulse-Oxygen > 95)
  6. Ejection fraction ≤ 45
  7. 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:

  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 of randomization
  9. Any condition requiring immunosuppressive medication
  10. A high-risk acute coronary syndrome (ACS) or a myocardial infarction within 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) prior to randomization
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01556022
Other Study ID Numbers  ICMJE The ATHENA Trial
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Cytori Therapeutics
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Cytori Therapeutics
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Emerson Perin, MD, PhD Texas Heart Institute, Houston, TX
Principal Investigator: Timothy Henry, MD Minneapolis Heart Institute Foundation, Minneapolis, MN
PRS Account Cytori Therapeutics
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP