Myocardial IschemiaPhase 2ATHENANCT01556022
Safety and Feasibility Trial of Adipose-Derived Regenerative Cells in the Treatment of Chronic Myocardial Ischemia
A Phase 2 study testing ADRCs processed by the Celution System in people with Myocardial Ischemia, run by Cytori Therapeutics at 8 sites in United States.
Trial summary
This is a prospective, randomized, placebo-controlled, double blind safety and feasibility clinical trial. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Myocardial Ischemia
- What is being tested?
- ADRCs processed by the Celution System
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 8 sitesUnited States
- Study dates
- Jun 2012to Oct 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Cardiology, P.C.
Birmingham, Alabama, 35211
Duke University Hospital
Durham, North Carolina, 27705
University of Florida
Gainesville, Florida, 32610
Texas Heart Institute
Houston, Texas, 77030
Scripps Clinic - Torrey Pines, Scripps Green Hospital
La Jolla, California, 92037
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
University of Utah Health Care
Salt Lake City, Utah, 84132
Florida Hospital-Pepin Heart Institute
Tampa, Florida, 33613
About this study
Official title: Adipose-derived Regenerative Cells in the Treatment of Patients With Chronic Ischemic Heart Disease Not Amenable to Surgical or Interventional Revascularization.
This is a prospective, randomized, placebo-controlled, double blind safety and feasibility clinical trial.
Read the 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.
- Conditions
- Myocardial Ischemia
- Being tested
- ADRCs processed by the Celution System, Placebo Comparator: Lactated Ringer's and Subject's Blood
- Keywords
- Ischemic heart disease, Coronary artery disease, Chronic heart failure, Cardiovascular disease, Adult stem cells, Adipose derived regenerative cells
- Medical subject headings
- Myocardial Ischemia, Coronary Artery Disease, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADRCs processed by the Celution SystemDevice
Also called ADRCs, Intramyocardial injections
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.
Placebo Comparator: Lactated Ringer's and Subject's BloodDevice
Also called Placebo
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Placebo Comparator: Lactated Ringer's and Subject's Blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- 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
Measured: 6 and 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2012 (estimated)
- Study startJun 2012
- Primary completionAug 2015
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cytori Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Emerson Perin, MD, PhD, Principal investigator, Texas Heart Institute, Houston, TXTimothy Henry, MD, Principal investigator, Minneapolis Heart Institute Foundation, Minneapolis, MN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01556022
- Sponsor's protocol ID
- The ATHENA Trial
- Acronym
- ATHENA
- Status last verified
- Oct 2016
- First submitted
- 14 Mar 2012
- Last updated
- 28 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 27148802
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adipose-derived Regenerative Cells in the Treatment of Patients With Chronic Ischemic Heart Disease Not Amenable to Surgical or Interventional Revascularization.
- ClinicalTrials.gov ID
- NCT01556022
- Acronym / sponsor ID
- ATHENA / The ATHENA Trial
- Conditions
- Myocardial Ischemia
- Keywords
- Ischemic heart disease, Coronary artery disease, Chronic heart failure, Cardiovascular disease, Adult stem cells, Adipose derived regenerative cells
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Cytori TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Aug 2015 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 16 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, randomized, placebo-controlled, double blind safety and feasibility clinical trial.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADRCs processed by the Celution System | Experimental | Device: ADRCs processed by the Celution System400,000 adipose-derived regenerative cells (ADRCs) per kilogram (kg) of body weight not to exceed 40,000,000 cells. |
| Lactated Ringers and Subject's blood | Placebo comparator | Device: Placebo Comparator: Lactated Ringer's and Subject's BloodSterile Lactated Ringers Solution (3mL) mixed with ≤ 0.10 ml of the study Subject's own freshly drawn blood. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADRCs processed by the Celution SystemAlso: ADRCs, Intramyocardial injectionsSubjects 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 | ADRCs processed by the Celution System |
| Placebo Comparator: Lactated Ringer's and Subject's BloodAlso: PlaceboSubjects 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. | Device | Lactated Ringers and Subject's blood |
Primary outcome
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: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2016.
- Results publication: PubMed 27148802Henry 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emerson Perin, MD, PhD principal investigator
Texas Heart Institute, Houston, TX
Timothy Henry, MD principal investigator
Minneapolis Heart Institute Foundation, Minneapolis, MN
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ADRCs processed by the Celution System in people with Myocardial Ischemia, run by Cytori Therapeutics at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01556022, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2016.