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

Myocardial Ischemia Clinical Trial

— ATHENA II  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02052427
• Other study ID #: ATHENA II
• Status: Completed
• Phase: Phase 2
• First received: January 30, 2014
• Last updated: October 26, 2016
• Start date: January 2014
• 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 efficacy clinical trial.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• 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

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

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Ischemia
• Myocardial Ischemia

Intervention

Device:
• Celution System
ADRCs processed by the Celution System for reintroduction into the myocardium
• Placebo
Physiological solution made of Lactated Ringers solution and a small amount (<1mL) of autologous blood

Locations

Country	Name	City	State
United States	University Hospital Case Medical Center	Cleveland	Ohio

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
Other	Safety - Number of Patients Experiencing Treatment Emergent SAEs		Treatment through 12 months	Yes
Other	Safety - Number of Patients Experiencing Arrhythmias Assessed via Holter monitor		Screening through 3 months post treatment	Yes
Other	Safety - Number of patients that experience a MACE	Number of patients that experience a Major Adverse Cardiac Event (MACE)	Treatment through 12 months	Yes
Primary	Primary Efficacy - Change in Minnesota Living with Heart Failure Questionnaire	Change in Minnesota Living with Heart Failure Questionnaire prior to treatment and at 6 months post treatment.	6 months post treatment	No
Secondary	Secondary Efficacy - Change in mVO2	Change in mVO2 at 6 months as assessed by Exercise Tolerance Test	6 months post treatment	No
Secondary	Secondary Efficacy - Change in LVESV/LVEDV	Change in LVESV/LVEDV at 6 months as assessed by Echocardiography	6 months post treatment	No
Secondary	Secondary Efficacy - Change in Ejection Fraction	Change in Ejection Fraction (%) at 6 months assessed by 2D Contrast Echocardiography	6 months post treatment	No
Secondary	Secondary Efficacy - Change in perfusion defect	Change in perfusion defect at 6 months assessed by Rest/Pharmacologic Stress SPECT	6 months post treatment	No
Secondary	Secondary Efficacy - Resource Utilization	Resource utilization - hospital length of stay, re-hospitalization for cardiac related events	through 12 months post treatment	No
Secondary	Secondary Efficacy - Change in heart failure symptoms, angina, and quality of life	Change in heart failure symptoms, angina, and quality of life assessed by - NYHA classification, CCS classification, MLHFQ (other than 6 months)	through 12 months post treatment	No