Overview

This trial is active, not recruiting.

Condition myocardial ischemia
Treatments adrcs processed by the celution system, placebo comparator: lactated ringer's and subject's blood
Phase phase 2
Sponsor Cytori Therapeutics
Start date June 2012
End date August 2015
Trial size 28 participants
Trial identifier NCT01556022, The ATHENA Trial

Summary

This is a prospective, randomized, placebo-controlled, double blind safety and feasibility 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, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
400,000 adipose-derived regenerative cells (ADRCs) per kilogram (kg) of body weight not to exceed 40,000,000 cells.
adrcs processed by the celution system ADRCs
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.
(Placebo Comparator)
Sterile Lactated Ringers Solution (3mL) mixed with ≤ 0.10 ml of the study Subject's own freshly drawn blood.
placebo comparator: lactated ringer's and subject's blood Placebo
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.

Primary Outcomes

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

Eligibility Criteria

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

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

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.
Principal investigator Emerson Perin, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Cytori Therapeutics.