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

Sponsor
Cytori Therapeutics (Industry)
Overall Status
Completed
CT.gov ID
NCT02052427
Collaborator
(none)
3
Enrollment
1
Location
2
Arms
33
Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Celution System
  • Device: Placebo
 Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
3 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Adipose-derived Regenerative Cells in the Treatment of Patients With Chronic Ischemic Heart Disease Not Amenable to Surgical or Interventional Revascularization II
Study Start Date :
Jan 1, 2014
Actual Primary Completion Date :
Aug 1, 2015
Actual Study Completion Date :
Oct 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: ADRCs

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

Device: Celution System
ADRCs processed by the Celution System for reintroduction into the myocardium
Placebo Comparator: Placebo

Placebo - Physiological Solution Inactive substance (Lactated Ringers + autologous blood) Delivered via the MYOSTAR™ Injection Catheter in 15 intramyocardial injections

Device: Placebo
Physiological solution made of Lactated Ringers solution and a small amount (<1mL) of autologous blood

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Secondary Efficacy - Change in mVO2 [6 months post treatment]

    Change in mVO2 at 6 months as assessed by Exercise Tolerance Test

  2. Secondary Efficacy - Change in LVESV/LVEDV [6 months post treatment]

    Change in LVESV/LVEDV at 6 months as assessed by Echocardiography

  3. Secondary Efficacy - Change in Ejection Fraction [6 months post treatment]

    Change in Ejection Fraction (%) at 6 months assessed by 2D Contrast Echocardiography

  4. Secondary Efficacy - Change in perfusion defect [6 months post treatment]

    Change in perfusion defect at 6 months assessed by Rest/Pharmacologic Stress SPECT

  5. Secondary Efficacy - Resource Utilization [through 12 months post treatment]

    Resource utilization - hospital length of stay, re-hospitalization for cardiac related events

  6. 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)

Other Outcome Measures

  1. Safety - Number of Patients Experiencing Treatment Emergent SAEs [Treatment through 12 months]

  2. Safety - Number of Patients Experiencing Arrhythmias Assessed via Holter monitor [Screening through 3 months post treatment]

  3. Safety - Number of patients that experience a MACE [Treatment through 12 months]

    Number of patients that experience a Major Adverse Cardiac Event (MACE)

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital Case Medical Center Cleveland Ohio United States 11100

Sponsors and Collaborators

  • Cytori Therapeutics

Investigators

  • Principal Investigator: Emerson C. Perin, MD, PhD, The Stem Cell Center at Texas Heart Institute
  • Principal Investigator: Timothy Henry, MD, Cedars-Sinai Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Cytori Therapeutics
ClinicalTrials.gov Identifier:
NCT02052427
Other Study ID Numbers:
  • ATHENA II
First Posted:
Feb 3, 2014
Last Update Posted:
Oct 28, 2016
Last Verified:
Oct 1, 2016
Keywords provided by Cytori Therapeutics
Ischemic heart disease
Coronary artery disease
Chronic Heart Failure
Cardiovascular disease
adult stem cells
adipose derived regenerative cells
Additional relevant MeSH terms:
Myocardial Ischemia
Coronary Artery Disease
Ischemia

Study Results

No Results Posted as of Oct 28, 2016