We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 2 for:    "Cytori" and "ATHENA"
Previous Study | Return to List | Next Study

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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This is a prospective, randomized, placebo-controlled, double blind safety and efficacy clinical trial.

Condition or disease Intervention/treatment Phase
Myocardial Ischemia Device: Celution System Device: Placebo Phase 2

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : January 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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
 Device: Celution System
ADRCs processed by the Celution System for reintroduction into the myocardium
Placebo Comparator: Placebo

Placebo - Physiological Solution

  • Inactive substance (Lactated Ringers + autologous blood)
  • Delivered via the MYOSTAR™ Injection Catheter in 15 intramyocardial injections
 Device: Placebo
Physiological solution made of Lactated Ringers solution and a small amount (<1mL) of autologous blood


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Secondary Efficacy - Change in mVO2 [ Time Frame: 6 months post treatment ]
    Change in mVO2 at 6 months as assessed by Exercise Tolerance Test

  2. Secondary Efficacy - Change in LVESV/LVEDV [ Time Frame: 6 months post treatment ]
    Change in LVESV/LVEDV at 6 months as assessed by Echocardiography

  3. Secondary Efficacy - Change in Ejection Fraction [ Time Frame: 6 months post treatment ]
    Change in Ejection Fraction (%) at 6 months assessed by 2D Contrast Echocardiography

  4. 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

  5. Secondary Efficacy - Resource Utilization [ Time Frame: through 12 months post treatment ]
    Resource utilization - hospital length of stay, re-hospitalization for cardiac related events

  6. 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)


Other Outcome Measures:
  1. Safety - Number of Patients Experiencing Treatment Emergent SAEs [ Time Frame: Treatment through 12 months ]
  2. Safety - Number of Patients Experiencing Arrhythmias Assessed via Holter monitor [ Time Frame: Screening through 3 months post treatment ]
  3. 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)


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02052427


Locations
Layout table for location information
United States, Ohio
University Hospital Case Medical Center
Cleveland, Ohio, United States, 11100
Sponsors and Collaborators
Cytori Therapeutics
Investigators
Layout table for investigator information
Principal Investigator: Emerson C. Perin, MD, PhD The Stem Cell Center at Texas Heart Institute
Principal Investigator: Timothy Henry, MD Cedars-Sinai Medical Center
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Layout table for additonal information
Responsible Party: Cytori Therapeutics
ClinicalTrials.gov Identifier: NCT02052427    
Other Study ID Numbers: ATHENA II
First Posted: February 3, 2014    Key Record Dates
Last Update Posted: October 28, 2016
Last Verified: October 2016
Keywords provided by Cytori Therapeutics:
Ischemic heart disease
Coronary artery disease
Chronic Heart Failure
 Cardiovascular disease
adult stem cells
adipose derived regenerative cells
Additional relevant MeSH terms:
Layout table for MeSH terms
Myocardial Ischemia
Coronary Artery Disease
Ischemia
Heart Diseases
Cardiovascular Diseases
 Pathologic Processes
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases