NCT01556022

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2012

Typical duration for phase_2

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 16, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

October 28, 2016

Status Verified

October 1, 2016

Enrollment Period

3.2 years

First QC Date

March 14, 2012

Last Update Submit

October 26, 2016

Conditions

Myocardial Ischemia

Keywords

Ischemic heart diseaseCoronary artery diseaseChronic heart failureCardiovascular diseaseAdult stem cellsAdipose derived regenerative cells

Outcome Measures

Primary Outcomes (1)

  • Treatment emergent serious adverse events (SAEs), major adverse cardiac events (MACE), arrhythmia assessment, change in cardiac function and symptoms, and resource utilization

    Safety endpoints include: 1. Treatment emergent SAEs 2. Arrhythmia assessment via Holter monitoring 3. MACE defined as cardiac death and hospitalization for heart failure Feasibility endpoints include: 1. Change in mVO2 at 6 months 2. Change in LVESV/LVEDV at 6 months 3. Change in ejection fraction at 6 months 4. Change in perfusion defect at 6 months 5. Resource utilization 6. Change in heart failure symptoms, angina, and quality of life through 12 months

    6 and 12 Months

Study Arms (2)

ADRCs processed by the Celution System

EXPERIMENTAL

400,000 adipose-derived regenerative cells (ADRCs) per kilogram (kg) of body weight not to exceed 40,000,000 cells.

Device: ADRCs processed by the Celution System

Lactated Ringers and Subject's blood

PLACEBO COMPARATOR

Sterile Lactated Ringers Solution (3mL) mixed with ≤ 0.10 ml of the study Subject's own freshly drawn blood.

Device: Placebo Comparator: Lactated Ringer's and Subject's Blood

Interventions

ADRCs processed by the Celution SystemDEVICE

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.

Also known as: ADRCs, Intramyocardial injections
ADRCs processed by the Celution System
Placebo Comparator: Lactated Ringer's and Subject's BloodDEVICE

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.

Also known as: Placebo
Lactated Ringers and Subject's blood

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males or females 20-80 years of age
  • Significant multi-vessel coronary artery disease not amenable to percutaneous or surgical revascularization in the target area
  • 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 (Systolic Blood Pressure ≥ 90 mm/Hg, Heart Rate \< 110; Pulse-Oxygen \> 95)
  • Ejection fraction ≤ 45
  • 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

You may not qualify if:

  • 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 of randomization
  • Any condition requiring immunosuppressive medication
  • A high-risk acute coronary syndrome (ACS) or a myocardial infarction within 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) prior to randomization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Cardiology, P.C.

Birmingham, Alabama, 35211, United States

Location

Scripps Clinic - Torrey Pines, Scripps Green Hospital

La Jolla, California, 92037, United States

Location

University of Florida

Gainesville, Florida, 32610, United States

Location

Florida Hospital-Pepin Heart Institute

Tampa, Florida, 33613, United States

Location

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407, United States

Location

Duke University Hospital

Durham, North Carolina, 27705, United States

Location

Texas Heart Institute

Houston, Texas, 77030, United States

Location

University of Utah Health Care

Salt Lake City, Utah, 84132, United States

Location

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

    PMID: 27148802RESULT

MeSH Terms

Conditions

Myocardial IschemiaCoronary Artery DiseaseCardiovascular Diseases

Condition Hierarchy (Ancestors)

Heart DiseasesVascular DiseasesCoronary DiseaseArteriosclerosisArterial Occlusive Diseases

Study Officials

  • Emerson Perin, MD, PhD

    Texas Heart Institute, Houston, TX

    PRINCIPAL INVESTIGATOR

  • Timothy Henry, MD

    Minneapolis Heart Institute Foundation, Minneapolis, MN

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2012

First Posted

March 16, 2012

Study Start

June 1, 2012

Primary Completion

August 1, 2015

Study Completion

October 1, 2016

Last Updated

October 28, 2016

Record last verified: 2016-10

Locations

US(8)