Myocardial InfarctionPhase 1NCT00442806
Randomized Clinical Trial of Adipose-Derived Stem Cells in the Treatment of Pts With ST-elevation Myocardial Infarction
A Phase 1 study testing Injection of ADRC's in people with Myocardial Infarction and Coronary Arteriosclerosis, run by Cytori Therapeutics at 2 sites in 2 countries.
Trial summary
The purpose of this study is to establish safety and feasibility of utilizing Adipose-Derived Stem and Regenerative Cells (ADRC's) in patients who have suffered a ST-elevation acute myocardial infarction. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Myocardial Infarction, Coronary Arteriosclerosis, Cardiovascular Disease
- What is being tested?
- Injection of ADRC's
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Nov 2007to Apr 2012
- Phase
- Phase 1
- 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
- Acute myocardial infarction (AMI)
- Clinical symptoms consistent with AMI for a minimum of 2 and a maximum of 12 hours from onset of symptoms to Percutaneous Coronary Intervention (PCI), and unresponsive to nitroglycerin
- Successful revascularization of the culprit lesion in the major epicardial vessel
- Area of hypo- or akinesia corresponding to the culprit lesion, as determined by left ventriculogram at the time of primary PCI
- Left ventricular ejection fraction (LVEF) ≥30% and ≤50% by Left Ventricular Angiography at the time of successful revascularization.
- Ability to undergo liposuction
Who cannot join
- Prior MI, prior known cardiomyopathy, or prior hospital admission for congestive heart failure (CHF)
- More than 24 hours after acute PCI
- Significant valvular disease
- More than twelve hours between the onset of first symptoms of AMI and revascularization
- Hemodynamic instability within 24 hours prior to randomization
- Neoplasia
Show all 10Show fewer
- Acute or chronic bacterial or viral infectious disease
- Pacemaker, ICD or any other contra-indication for MRI
- LVEF <30% or >50% by Left Ventricular Angiography
- Moderate or severe COPD
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Netherlands1 site
Erasmus University Medical Centrum, Thorax Center
Rotterdam
About this study
Official title: A Randomized Clinical Trial of AdiPOse-derived Stem ceLLs in the Treatment of Patients With ST-elevation myOcardial Infarction - The APOLLO Trial
The purpose of this study is to establish safety and feasibility of utilizing Adipose-Derived Stem and Regenerative Cells (ADRC's) in patients who have suffered a ST-elevation acute myocardial infarction.
Read the detailed description
Subjects who have coronary artery disease and have suffered a ST-elevation acute myocardial infarction will be evaluated for eligibility in this study. Eligible subjects will undergo standard treatment after admission to the hospital and will then undergo liposuction under local anesthesia, after which ADRC's will be isolated from the lipoaspirate. According to randomization subjects will receive either ADRC's or placebo.
- Conditions
- Myocardial Infarction, Coronary Arteriosclerosis, Cardiovascular Disease, Coronary Disease
- Being tested
- Injection of ADRC's, Injection of Placebo
- Keywords
- ADRC, Stem Cells, Myocardial Infarction, STEMI, Heart Disease, Coronary Artery Disease, Coronary Disease, ST-Elevation, AMI, Interventional Cardiology, Heart Attack
- Medical subject headings
- Myocardial Infarction, Coronary Artery Disease, Cardiovascular Diseases, Coronary Disease, ST Elevation Myocardial Infarction, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection of ADRC'sDrug
ADRC's are injected
Injection of PlaceboOther
Placebo is injected
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo is injected Receives: Other: Injection of Placebo |
| Treatment | Experimental | ADRC's are injected Receives: Drug: Injection of ADRC's |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - Determined by Major Adverse Cardiac and Cerebral Events (MACCE)
Measured: 6 months
Secondary outcomes (1)
Feasibility - Assessment of cardiac function via functional and imaging studies including MRI, SPECT, and Echocardiography
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2007 (estimated)
- Study startNov 2007
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cytori Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric Duckers, MD, PhD, Principal investigator, Erasmus University Medical Centrum, ThoraxCenter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00442806
- Sponsor's protocol ID
- APOLLO - 01
- Status last verified
- Nov 2013
- First submitted
- 28 Feb 2007
- Last updated
- 26 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial of AdiPOse-derived Stem ceLLs in the Treatment of Patients With ST-elevation myOcardial Infarction - The APOLLO Trial
- ClinicalTrials.gov ID
- NCT00442806
- Acronym / sponsor ID
- APOLLO - 01
- Conditions
- Myocardial Infarction, Coronary Arteriosclerosis, Cardiovascular Disease, Coronary Disease
- Keywords
- ADRC, Stem Cells, Myocardial Infarction, STEMI, Heart Disease, Coronary Artery Disease, Coronary Disease, ST-Elevation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Cytori TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 2 Mar 2007 (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.
The purpose of this study is to establish safety and feasibility of utilizing Adipose-Derived Stem and Regenerative Cells (ADRC's) in patients who have suffered a ST-elevation acute myocardial infarction.
Detailed description
Subjects who have coronary artery disease and have suffered a ST-elevation acute myocardial infarction will be evaluated for eligibility in this study. Eligible subjects will undergo standard treatment after admission to the hospital and will then undergo liposuction under local anesthesia, after which ADRC's will be isolated from the lipoaspirate. According to randomization subjects will receive either ADRC's or placebo.
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 |
|---|---|---|
| Placebo | Placebo comparator | Other: Injection of PlaceboPlacebo is injected |
| Treatment | Experimental | Drug: Injection of ADRC'sADRC's are injected |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Acute myocardial infarction (AMI)
- Clinical symptoms consistent with AMI for a minimum of 2 and a maximum of 12 hours from onset of symptoms to Percutaneous Coronary Intervention (PCI), and unresponsive to nitroglycerin
- Successful revascularization of the culprit lesion in the major epicardial vessel
- Area of hypo- or akinesia corresponding to the culprit lesion, as determined by left ventriculogram at the time of primary PCI
- Left ventricular ejection fraction (LVEF) ≥30% and ≤50% by Left Ventricular Angiography at the time of successful revascularization.
Key exclusion criteria (10 listed)
- Prior MI, prior known cardiomyopathy, or prior hospital admission for congestive heart failure (CHF)
- More than 24 hours after acute PCI
- Significant valvular disease
- More than twelve hours between the onset of first symptoms of AMI and revascularization
- Hemodynamic instability within 24 hours prior to randomization
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 |
|---|---|---|
| Injection of ADRC'sADRC's are injected | Drug | Treatment |
| Injection of PlaceboPlacebo is injected | Other | Placebo |
Primary outcome
Safety - Determined by Major Adverse Cardiac and Cerebral Events (MACCE)
Time frame: 6 months
1 secondary outcome
Feasibility - Assessment of cardiac function via functional and imaging studies including MRI, SPECT, and Echocardiography
Time frame: 6 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 26 Nov 2013.
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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.
Eric Duckers, MD, PhD principal investigator
Erasmus University Medical Centrum, ThoraxCenter
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Injection of ADRC's in people with Myocardial Infarction and Coronary Arteriosclerosis, run by Cytori Therapeutics at 2 sites in 2 countries.
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 6 inclusion and 10 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 26 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands, Spain. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Safety - Determined by Major Adverse Cardiac and Cerebral Events (MACCE) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Nov 2013.