Overview

This trial has been completed.

Condition myocardial ischemia
Treatments celution system, placebo
Phase phase 2
Sponsor Cytori Therapeutics
Start date January 2014
End date August 2015
Trial size 3 participants
Trial identifier NCT02052427, ATHENA II

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
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
celution system
ADRCs processed by the Celution System for reintroduction into the myocardium
(Placebo Comparator)
Placebo - Physiological Solution Inactive substance (Lactated Ringers + autologous blood) Delivered via the MYOSTAR™ Injection Catheter in 15 intramyocardial injections
placebo
Physiological solution made of Lactated Ringers solution and a small amount (<1mL) of autologous blood

Primary Outcomes

Measure
Primary Efficacy - Change in Minnesota Living with Heart Failure Questionnaire
time frame: 6 months post treatment

Secondary Outcomes

Measure
Secondary Efficacy - Change in mVO2
time frame: 6 months post treatment
Secondary Efficacy - Change in LVESV/LVEDV
time frame: 6 months post treatment
Secondary Efficacy - Change in Ejection Fraction
time frame: 6 months post treatment
Secondary Efficacy - Change in perfusion defect
time frame: 6 months post treatment
Secondary Efficacy - Resource Utilization
time frame: through 12 months post treatment
Secondary Efficacy - Change in heart failure symptoms, angina, and quality of life
time frame: through 12 months post treatment

Eligibility Criteria

Male or female participants from 20 years up to 80 years old.

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

Additional Information

Official title Adipose-derived Regenerative Cells in the Treatment of Patients With Chronic Ischemic Heart Disease Not Amenable to Surgical or Interventional Revascularization II
Principal investigator Emerson C. Perin, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Cytori Therapeutics.