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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cytori Therapeutics
ClinicalTrials.gov Identifier:
NCT01556022
First received: March 14, 2012
Last updated: November 19, 2014
Last verified: November 2014
  Purpose

This is a prospective, randomized, placebo-controlled, double blind safety and feasibility clinical trial.


Condition Intervention Phase
Myocardial Ischemia
Device: ADRCs processed by the Celution System
Device: Placebo Comparator: Lactated Ringer's and Subject's Blood
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:


Further study details as provided by Cytori Therapeutics:

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 [ Time Frame: 6 and 12 Months ] [ Designated as safety issue: Yes ]

    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


Enrollment: 28
Study Start Date: June 2012
Estimated Study Completion Date: May 2019
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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.
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01556022

Locations
United States, Alabama
Cardiology, P.C.
Birmingham, Alabama, United States, 35211
United States, California
Scripps Clinic - Torrey Pines, Scripps Green Hospital
La Jolla, California, United States, 92037
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Florida Hospital-Pepin Heart Institute
Tampa, Florida, United States, 33613
United States, Minnesota
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States, 55407
United States, North Carolina
Duke University Hospital
Durham, North Carolina, United States, 27705
United States, Texas
Texas Heart Institute
Houston, Texas, United States, 77030
United States, Utah
University of Utah Health Care
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
Cytori Therapeutics
Investigators
Principal Investigator: Emerson Perin, MD, PhD Texas Heart Institute, Houston, TX
Principal Investigator: Timothy Henry, MD Minneapolis Heart Institute Foundation, Minneapolis, MN
  More Information

No publications provided

Responsible Party: Cytori Therapeutics
ClinicalTrials.gov Identifier: NCT01556022     History of Changes
Other Study ID Numbers: The ATHENA Trial
Study First Received: March 14, 2012
Last Updated: November 19, 2014
Health Authority: United States: Food and Drug Administration

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:
Coronary Artery Disease
Ischemia
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on November 27, 2014