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

Cytori Therapeutics

Status and phase: Completed; Phase 2

Conditions: Myocardial Ischemia

Treatments: Device: ADRCs processed by the Celution System; Device: Placebo Comparator: Lactated Ringer's and Subject's Blood

Study type: Interventional

Funder types: Industry

Identifiers

NCT01556022

The ATHENA Trial

Details and patient eligibility

About

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

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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28 participants in 2 patient groups, including a placebo group

ADRCs processed by the Celution System

Experimental group

Description:

400,000 adipose-derived regenerative cells (ADRCs) per kilogram (kg) of body weight not to exceed 40,000,000 cells.

Treatment:

Device: ADRCs processed by the Celution System

Lactated Ringers and Subject's blood

Placebo Comparator group

Description:

Sterile Lactated Ringers Solution (3mL) mixed with ≤ 0.10 ml of the study Subject's own freshly drawn blood.

Treatment:

Device: Placebo Comparator: Lactated Ringer's and Subject's Blood