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

Overview

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

Full Title of Study: “Adipose-derived Regenerative Cells in the Treatment of Patients With Chronic Ischemic Heart Disease Not Amenable to Surgical or Interventional Revascularization.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: August 2015

Detailed 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.

Interventions

  • 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.
  • Device: 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.

Arms, Groups and Cohorts

  • Experimental: ADRCs processed by the Celution System
    • 400,000 adipose-derived regenerative cells (ADRCs) per kilogram (kg) of body weight not to exceed 40,000,000 cells.
  • Placebo Comparator: Lactated Ringers and Subject’s blood
    • Sterile Lactated Ringers Solution (3mL) mixed with ≤ 0.10 ml of the study Subject’s own freshly drawn blood.

Clinical Trial Outcome Measures

Primary Measures

  • Treatment emergent serious adverse events (SAEs), major adverse cardiac events (MACE), arrhythmia assessment, change in cardiac function and symptoms, and resource utilization
    • Time Frame: 6 and 12 Months
    • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Cytori Therapeutics
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Emerson Perin, MD, PhD, Principal Investigator, Texas Heart Institute, Houston, TX
    • Timothy Henry, MD, Principal Investigator, Minneapolis Heart Institute Foundation, Minneapolis, MN

Citations Reporting on Results

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 ventricular dysfunction. Catheter Cardiovasc Interv. 2017 Feb 1;89(2):169-177. doi: 10.1002/ccd.26601. Epub 2016 Sep 23.

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