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

Myocardial Ischemia Clinical Trial

— ATHENA  

Official title:

Adipose-derived Regenerative Cells in the Treatment of Patients With Chronic Ischemic Heart Disease Not Amenable to Surgical or Interventional Revascularization.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01556022
• Other study ID #: The ATHENA Trial
• Status: Completed
• Phase: Phase 2
• First received: March 14, 2012
• Last updated: October 26, 2016
• Start date: June 2012
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: Cytori Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: October 2016
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Ischemia
• Myocardial Ischemia

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Cardiology, P.C.	Birmingham	Alabama
United States	Duke University Hospital	Durham	North Carolina
United States	University of Florida	Gainesville	Florida
United States	Texas Heart Institute	Houston	Texas
United States	Scripps Clinic - Torrey Pines, Scripps Green Hospital	La Jolla	California
United States	Minneapolis Heart Institute Foundation	Minneapolis	Minnesota
United States	University of Utah Health Care	Salt Lake City	Utah
United States	Florida Hospital-Pepin Heart Institute	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Cytori Therapeutics

Country where clinical trial is conducted

United States, 

References & Publications (1)

Henry TD, Pepine CJ, Lambert CR, Traverse JH, Schatz R, Costa M, Povsic TJ, David Anderson R, Willerson JT, Kesten S, Perin EC. The Athena trials: Autologous adipose-derived regenerative cells for refractory chronic myocardial ischemia with left ventricul — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment emergent serious adverse events (SAEs), major adverse cardiac events (MACE), arrhythmia assessment, change in cardiac function and symptoms, and resource utilization	Safety endpoints include: Treatment emergent SAEs; Arrhythmia assessment via Holter monitoring; MACE defined as cardiac death and hospitalization for heart failure; Feasibility endpoints include: Change in mVO2 at 6 months; Change in LVESV/LVEDV at 6 months; Change in ejection fraction at 6 months; Change in perfusion defect at 6 months; Resource utilization; Change in heart failure symptoms, angina, and quality of life through 12 months	6 and 12 Months	Yes