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

This study is currently recruiting participants.
Verified January 2014 by Cytori Therapeutics
Sponsor:
Information provided by (Responsible Party):
Cytori Therapeutics
ClinicalTrials.gov Identifier:
NCT01556022
First received: March 14, 2012
Last updated: January 30, 2014
Last verified: January 2014

March 14, 2012
January 30, 2014
June 2012
May 2014   (final data collection date for primary outcome measure)
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
Treatment emergent serious adverse events (SAEs),major adverse cardiac events (MACE) and Arrhythmia Assessment [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]

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
Complete list of historical versions of study NCT01556022 on ClinicalTrials.gov Archive Site
Not Provided
Change in Cardiac Function [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  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
Not Provided
Not Provided
 
Safety and Feasibility Trial of Adipose-Derived Regenerative Cells in the Treatment of Chronic Myocardial Ischemia
Adipose-derived Regenerative Cells in the Treatment of Patients With Chronic Ischemic Heart Disease Not Amenable to Surgical or Interventional Revascularization.

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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Myocardial Ischemia
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
45
May 2019
May 2014   (final data collection date for primary outcome measure)

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
Both
20 Years to 80 Years
No
Contact: Eve Taylor, PhD 858-458-0900 etaylor@cytori.com
Contact: Rhiannon Dabkowski, BS 858-458-0900 rdabkowski@cytori.com
United States
 
NCT01556022
The ATHENA Trial
Yes
Cytori Therapeutics
Cytori Therapeutics
Not Provided
Principal Investigator: Emerson Perin, MD, PhD Texas Heart Institute, Houston, TX
Principal Investigator: Timothy Henry, MD Minneapolis Heart Institute Foundation, Minneapolis, MN
Cytori Therapeutics
January 2014

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