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Trial record 2 of 2 for:    "Cytori" and "ATHENA"

Safety & Efficacy of Adipose-Derived Regenerative Cells in the Treatment of Chronic Myocardial Ischemia (ATHENA II) (ATHENA II)

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: NCT02052427
Recruitment Status : Completed
First Posted : February 3, 2014
Last Update Posted : October 28, 2016
Sponsor:
Information provided by (Responsible Party):
Cytori Therapeutics

Tracking Information
First Submitted Date  ICMJE January 30, 2014
First Posted Date  ICMJE February 3, 2014
Last Update Posted Date October 28, 2016
Study Start Date  ICMJE January 2014
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2014)
Primary Efficacy - Change in Minnesota Living with Heart Failure Questionnaire [ Time Frame: 6 months post treatment ]
Change in Minnesota Living with Heart Failure Questionnaire prior to treatment and at 6 months post treatment.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2014)
  • Secondary Efficacy - Change in mVO2 [ Time Frame: 6 months post treatment ]
    Change in mVO2 at 6 months as assessed by Exercise Tolerance Test
  • Secondary Efficacy - Change in LVESV/LVEDV [ Time Frame: 6 months post treatment ]
    Change in LVESV/LVEDV at 6 months as assessed by Echocardiography
  • Secondary Efficacy - Change in Ejection Fraction [ Time Frame: 6 months post treatment ]
    Change in Ejection Fraction (%) at 6 months assessed by 2D Contrast Echocardiography
  • Secondary Efficacy - Change in perfusion defect [ Time Frame: 6 months post treatment ]
    Change in perfusion defect at 6 months assessed by Rest/Pharmacologic Stress SPECT
  • Secondary Efficacy - Resource Utilization [ Time Frame: through 12 months post treatment ]
    Resource utilization - hospital length of stay, re-hospitalization for cardiac related events
  • Secondary Efficacy - Change in heart failure symptoms, angina, and quality of life [ Time Frame: through 12 months post treatment ]
    Change in heart failure symptoms, angina, and quality of life assessed by - NYHA classification, CCS classification, MLHFQ (other than 6 months)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 30, 2014)
  • Safety - Number of Patients Experiencing Treatment Emergent SAEs [ Time Frame: Treatment through 12 months ]
  • Safety - Number of Patients Experiencing Arrhythmias Assessed via Holter monitor [ Time Frame: Screening through 3 months post treatment ]
  • Safety - Number of patients that experience a MACE [ Time Frame: Treatment through 12 months ]
    Number of patients that experience a Major Adverse Cardiac Event (MACE)
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Safety & Efficacy of Adipose-Derived Regenerative Cells in the Treatment of Chronic Myocardial Ischemia (ATHENA II)
Official Title  ICMJE Adipose-derived Regenerative Cells in the Treatment of Patients With Chronic Ischemic Heart Disease Not Amenable to Surgical or Interventional Revascularization II
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Myocardial Ischemia
Intervention  ICMJE
  • Device: Celution System
    ADRCs processed by the Celution System for reintroduction into the myocardium
  • Device: Placebo
    Physiological solution made of Lactated Ringers solution and a small amount (<1mL) of autologous blood
Study Arms  ICMJE
  • Experimental: ADRCs

    Adipose-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
    Intervention: Device: Celution System
  • Placebo Comparator: Placebo

    Placebo - Physiological Solution

    • Inactive substance (Lactated Ringers + autologous blood)
    • Delivered via the MYOSTAR™ Injection Catheter in 15 intramyocardial injections
    Intervention: Device: Placebo
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)
3
Original Estimated Enrollment  ICMJE
 (submitted: January 30, 2014)
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

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
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 NCT02052427
Other Study ID Numbers  ICMJE ATHENA II
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 C. Perin, MD, PhD The Stem Cell Center at Texas Heart Institute
Principal Investigator: Timothy Henry, MD Cedars-Sinai Medical Center
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