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

October 26, 2016 updated by: Cytori Therapeutics

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 11100
        • University Hospital Case Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Primary Efficacy - Change in Minnesota Living with Heart Failure Questionnaire
Time Frame: 6 months post treatment
Change in Minnesota Living with Heart Failure Questionnaire prior to treatment and at 6 months post treatment.
6 months post treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Secondary Efficacy - Change in mVO2
Time Frame: 6 months post treatment
Change in mVO2 at 6 months as assessed by Exercise Tolerance Test
6 months post treatment
Secondary Efficacy - Change in LVESV/LVEDV
Time Frame: 6 months post treatment
Change in LVESV/LVEDV at 6 months as assessed by Echocardiography
6 months post treatment
Secondary Efficacy - Change in Ejection Fraction
Time Frame: 6 months post treatment
Change in Ejection Fraction (%) at 6 months assessed by 2D Contrast Echocardiography
6 months post treatment
Secondary Efficacy - Change in perfusion defect
Time Frame: 6 months post treatment
Change in perfusion defect at 6 months assessed by Rest/Pharmacologic Stress SPECT
6 months post treatment
Secondary Efficacy - Resource Utilization
Time Frame: through 12 months post treatment
Resource utilization - hospital length of stay, re-hospitalization for cardiac related events
through 12 months post treatment
Secondary Efficacy - Change in heart failure symptoms, angina, and quality of life
Time Frame: 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)
through 12 months post treatment

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Safety - Number of Patients Experiencing Treatment Emergent SAEs
Time Frame: Treatment through 12 months
Treatment through 12 months
Safety - Number of Patients Experiencing Arrhythmias Assessed via Holter monitor
Time Frame: Screening through 3 months post treatment
Screening through 3 months post treatment
Safety - Number of patients that experience a MACE
Time Frame: Treatment through 12 months
Number of patients that experience a Major Adverse Cardiac Event (MACE)
Treatment through 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cytori Therapeutics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Emerson C. Perin, MD, PhD, The Stem Cell Center at Texas Heart Institute
  • Principal Investigator: Timothy Henry, MD, Cedars-Sinai Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 30, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 3, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 28, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ATHENA II

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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