Myocardial IschemiaPhase 2ATHENA IINCT02052427
Safety & Efficacy of Adipose-Derived Regenerative Cells in the Treatment of Chronic Myocardial Ischemia (ATHENA II)
A Phase 2 study testing Celution System in people with Myocardial Ischemia, run by Cytori Therapeutics at 1 site in United States.
Trial summary
This is a prospective, randomized, placebo-controlled, double blind safety and efficacy 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?
- 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
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to 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 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
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 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospital Case Medical Center
Cleveland, Ohio, 11100
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 II
This is a prospective, randomized, placebo-controlled, double blind safety and efficacy clinical trial.
Read the 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.
- Conditions
- Myocardial Ischemia
- Being tested
- Celution System, Placebo
- 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.
Celution SystemDevice
ADRCs processed by the Celution System for reintroduction into the myocardium
PlaceboDevice
Physiological solution made of Lactated Ringers solution and a small amount (<1mL) of autologous blood
| Study group | Role | What they receive |
|---|---|---|
| ADRCs | Experimental | 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 Receives: Device: Celution System |
| Placebo | Placebo comparator | Placebo - Physiological Solution
* Inactive substance (Lactated Ringers + autologous blood)
* Delivered via the MYOSTAR™ Injection Catheter in 15 intramyocardial injections Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months post treatment
Secondary outcomes (6)
Secondary Efficacy - Change in mVO2
Change in mVO2 at 6 months as assessed by Exercise Tolerance Test
Measured: 6 months post treatment
Secondary Efficacy - Change in LVESV/LVEDV
Change in LVESV/LVEDV at 6 months as assessed by Echocardiography
Measured: 6 months post treatment
Secondary Efficacy - Change in Ejection Fraction
Change in Ejection Fraction (%) at 6 months assessed by 2D Contrast Echocardiography
Measured: 6 months post treatment
Secondary Efficacy - Change in perfusion defect
Change in perfusion defect at 6 months assessed by Rest/Pharmacologic Stress SPECT
Measured: 6 months post treatment
Secondary Efficacy - Resource Utilization
Resource utilization - hospital length of stay, re-hospitalization for cardiac related events
Measured: through 12 months post treatment
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)
Measured: through 12 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2014 (estimated)
- Study startJan 2014
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cytori Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Emerson C. Perin, MD, PhD, Principal investigator, The Stem Cell Center at Texas Heart InstituteTimothy Henry, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02052427
- Sponsor's protocol ID
- ATHENA II
- Acronym
- ATHENA II
- Status last verified
- Oct 2016
- First submitted
- 30 Jan 2014
- 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 II
- ClinicalTrials.gov ID
- NCT02052427
- Acronym / sponsor ID
- ATHENA II / ATHENA II
- 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
- 3 participants (actual)
- Lead sponsor
- Cytori TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 3 Feb 2014 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADRCs | Experimental | Device: Celution SystemAdipose-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 | Placebo comparator | Device: PlaceboPlacebo - Physiological Solution * Inactive substance (Lactated Ringers + autologous blood) * Delivered via the MYOSTAR™ Injection Catheter in 15 intramyocardial injections |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (14 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 |
|---|---|---|
| Celution SystemADRCs processed by the Celution System for reintroduction into the myocardium | Device | ADRCs |
| PlaceboPhysiological solution made of Lactated Ringers solution and a small amount (<1mL) of autologous blood | Device | Placebo |
Primary outcome
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 secondary outcomes
Secondary Efficacy - Change in mVO2
Time frame: 6 months post treatment
Secondary Efficacy - Change in LVESV/LVEDV
Time frame: 6 months post treatment
Secondary Efficacy - Change in Ejection Fraction
Time frame: 6 months post treatment
Secondary Efficacy - Change in perfusion defect
Time frame: 6 months post treatment
Secondary Efficacy - Resource Utilization
Time frame: through 12 months post treatment
Secondary Efficacy - Change in heart failure symptoms, angina, and quality of life
Time frame: through 12 months post treatment
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 C. Perin, MD, PhD principal investigator
The Stem Cell Center at Texas Heart Institute
Timothy Henry, MD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Celution System in people with Myocardial Ischemia, run by Cytori Therapeutics at 1 site 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 8 inclusion and 14 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 1 site 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?
Primary Efficacy - Change in Minnesota Living with Heart Failure Questionnaire (time frame: 6 months post treatment). 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 NCT02052427, 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.