Safety & Efficacy of Adipose-Derived Regenerative Cells in the Treatment of Chronic Myocardial Ischemia (ATHENA II)

Phase 2

Completed

• Conditions: Myocardial Ischemia
• Interventions: Device: Celution System; Device: Placebo

• Registration Number: NCT02052427
• Lead Sponsor: Cytori Therapeutics

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-30
• Study First Submitted QC: 2014-01-30
• Study First Posted: 2014-02-03
• Primary Completion: 2015-08
• Status Verified: 2016-10
• Study Completion: 2016-10
• Last Update Submitted: 2016-10-26
• Last Update Posted: 2016-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ADRCs	Celution System	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
Placebo	Placebo	Placebo - Physiological Solution * Inactive substance (Lactated Ringers + autologous blood) * Delivered via the MYOSTAR™ Injection Catheter in 15 intramyocardial injections

Primary Outcome Measures

Name	Time	Method
Primary Efficacy - Change in Minnesota Living with Heart Failure Questionnaire	6 months post treatment	Change in Minnesota Living with Heart Failure Questionnaire prior to treatment and at 6 months post treatment.

Secondary Outcome Measures

Name	Time	Method
Secondary Efficacy - Change in perfusion defect	6 months post treatment	Change in perfusion defect at 6 months assessed by Rest/Pharmacologic Stress SPECT
Secondary Efficacy - Change in Ejection Fraction	6 months post treatment	Change in Ejection Fraction (%) at 6 months assessed by 2D Contrast Echocardiography
Secondary Efficacy - Change in heart failure symptoms, angina, and quality of life	through 12 months post treatment	Change in heart failure symptoms, angina, and quality of life assessed by - NYHA classification, CCS classification, MLHFQ (other than 6 months)
Secondary Efficacy - Change in mVO2	6 months post treatment	Change in mVO2 at 6 months as assessed by Exercise Tolerance Test
Secondary Efficacy - Change in LVESV/LVEDV	6 months post treatment	Change in LVESV/LVEDV at 6 months as assessed by Echocardiography
Secondary Efficacy - Resource Utilization	through 12 months post treatment	Resource utilization - hospital length of stay, re-hospitalization for cardiac related events

Trial Locations

Locations (1)

University Hospital Case Medical Center; 🇺🇸 Cleveland, Ohio, United States