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

Primary Purpose

Myocardial Ischemia

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Celution System

Placebo

About this trial

This is an interventional treatment trial for Myocardial Ischemia focused on measuring Ischemic heart disease, Coronary artery disease, Chronic Heart Failure, Cardiovascular disease, adult stem cells, adipose derived regenerative cells

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Males or females > 20 and < 80 years of age
Significant multi-vessel coronary artery disease not amenable to percutaneous or surgical revascularization
CCS Angina Functional Class II-IV and/or NYHA Stages of Heart Failure Class II or III
On maximal medical therapy for anginal symptoms and/or heart failure symptoms
Hemodynamic stability (SBP ≥ 90 mm/Hg, HR <110)
Ejection fraction ≥ 20% and ≤ 45%
Inducible ischemia using an objective assessment of ischemia within 1 year of screening (i.e. exercise ECG changes, SPECT)
Left ventricular wall thickness ≥ 8 mm at the target site for cell injection

Exclusion Criteria:

Atrial fibrillation or flutter without a pace maker that guarantees a stable heart rate
Unstable angina
LV thrombus, as documented by echocardiography
Planned staged treatment of CAD or other intervention on the heart
Platelet count < 100,000/mm3
WBC < 2,000/mm3
TIA or stroke within 90 days prior to randomization
ICD shock within 30 days prior to randomization
Any condition requiring immunosuppressive medication
A high-risk acute coronary syndrome (ACS) or a myocardial infarction in the 60 days prior to randomization
Revascularization within 60 days prior to randomization
Inability to walk on a treadmill except for class IV angina patients who will be evaluated separately
Hepatic dysfunction, as defined as aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 1.5 times the upper limit of normal range (x ULN)
Hemoglobin ≤ 10.0 g/dL

Sites / Locations

University Hospital Case Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ADRCs

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Secondary Efficacy - Change in mVO2

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

Secondary Efficacy - Change in LVESV/LVEDV

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

Secondary Efficacy - Change in Ejection Fraction

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

Secondary Efficacy - Change in perfusion defect

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

Secondary Efficacy - Resource Utilization

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

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)

Full Information

NCT ID

NCT02052427

First Posted

January 30, 2014

Last Updated

October 26, 2016

Sponsor

Cytori Therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT02052427

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

January 2014 (undefined)

Primary Completion Date

August 2015 (Actual)

Study Completion Date

October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cytori Therapeutics

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myocardial Ischemia

Keywords

Ischemic heart disease, Coronary artery disease, Chronic Heart Failure, Cardiovascular disease, adult stem cells, adipose derived regenerative cells

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ADRCs

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Celution System

Intervention Description

ADRCs processed by the Celution System for reintroduction into the myocardium

Intervention Type

Device

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Primary Efficacy - Change in Minnesota Living with Heart Failure Questionnaire

Description

Change in Minnesota Living with Heart Failure Questionnaire prior to treatment and at 6 months post treatment.

Time Frame

6 months post treatment

Secondary Outcome Measure Information:

Title

Secondary Efficacy - Change in mVO2

Description

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

Time Frame

6 months post treatment

Title

Secondary Efficacy - Change in LVESV/LVEDV

Description

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

Time Frame

6 months post treatment

Title

Secondary Efficacy - Change in Ejection Fraction

Description

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

Time Frame

6 months post treatment

Title

Secondary Efficacy - Change in perfusion defect

Description

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

Time Frame

6 months post treatment

Title

Secondary Efficacy - Resource Utilization

Description

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

Time Frame

through 12 months post treatment

Title

Secondary Efficacy - Change in heart failure symptoms, angina, and quality of life

Description

Change in heart failure symptoms, angina, and quality of life assessed by - NYHA classification, CCS classification, MLHFQ (other than 6 months)

Time Frame

through 12 months post treatment

Other Pre-specified Outcome Measures:

Title

Safety - Number of Patients Experiencing Treatment Emergent SAEs

Time Frame

Treatment through 12 months

Title

Safety - Number of Patients Experiencing Arrhythmias Assessed via Holter monitor

Time Frame

Screening through 3 months post treatment

Title

Safety - Number of patients that experience a MACE

Description

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

Time Frame

Treatment through 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Males or females > 20 and < 80 years of age Significant multi-vessel coronary artery disease not amenable to percutaneous or surgical revascularization CCS Angina Functional Class II-IV and/or NYHA Stages of Heart Failure Class II or III On maximal medical therapy for anginal symptoms and/or heart failure symptoms Hemodynamic stability (SBP ≥ 90 mm/Hg, HR <110) Ejection fraction ≥ 20% and ≤ 45% Inducible ischemia using an objective assessment of ischemia within 1 year of screening (i.e. exercise ECG changes, SPECT) Left ventricular wall thickness ≥ 8 mm at the target site for cell injection Exclusion Criteria: Atrial fibrillation or flutter without a pace maker that guarantees a stable heart rate Unstable angina LV thrombus, as documented by echocardiography Planned staged treatment of CAD or other intervention on the heart Platelet count < 100,000/mm3 WBC < 2,000/mm3 TIA or stroke within 90 days prior to randomization ICD shock within 30 days prior to randomization Any condition requiring immunosuppressive medication A high-risk acute coronary syndrome (ACS) or a myocardial infarction in the 60 days prior to randomization Revascularization within 60 days prior to randomization Inability to walk on a treadmill except for class IV angina patients who will be evaluated separately Hepatic dysfunction, as defined as aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 1.5 times the upper limit of normal range (x ULN) Hemoglobin ≤ 10.0 g/dL

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Emerson C. Perin, MD, PhD

Organizational Affiliation

The Stem Cell Center at Texas Heart Institute

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Timothy Henry, MD

Organizational Affiliation

Cedars-Sinai Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital Case Medical Center

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

11100

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

27148802

Citation

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.

Results Reference

result

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

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