Acute Myocardial InfarctionPhase 2ADVANCENCT01216995
Safety and Efficacy of Adipose Derived Regenerative Cells (ADRCs) Delivered Via the Intracoronary Route in the Treatment of Patients With ST-elevation Acute Myocardial Infarction (AMI)
A Phase 2 study testing Dose A in people with Acute Myocardial Infarction, run by Cytori Therapeutics at 4 sites in 2 countries.
Trial summary
Double blind, prospective, randomized, placebo-controlled Safety and Efficacy trial of ADRCs delivered via the intracoronary route in the treatment of patients with ST-elevation acute myocardial infarction (STEMI). Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- Dose A
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Sep 2012to May 2014
- 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
- ST-segment Elevation Myocardial Infarction (STEMI) Criteria:
- Ischemic symptoms AND
- ECG:
- Development of pathologic Q waves on the ECG; or
- ECG changes indicative of severe ischemia (ST segment elevation and/or depression); or
- New left bundle branch block; AND
- Creatine Phosphokinase Isoenzyme (MB Form) > 100 IU/L, or troponin >5x the upper limit of normal between admission and randomization
- Successful revascularization of the culprit lesion in a major epicardial vessel
Who cannot join
- More than 24 hours between PCI and start of liposuction
- Prior myocardial infarction, cardiomyopathy, or a history of congestive heart failure
- Pacemaker, ICD, or any other contra-indication for MRI
- Patients with increased bleeding risk
- Cardiogenic shock present post-index PCI
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Poland3 sites
Krakowski Szpital Specjalistyczny im. Jana Pawla II Oddzial Kliniczny Chorob Serca i Naczyn
Krakow, 31202
Szpital Uniwersytecki Samodzielna Pracownia Zakladu Hemodynamiki
Krakow, 31501
Samodzielny Publiczny Centralny Szpital Kliniczny Pracownia Kardiologii Inwazyjnej
Warsaw, 02097
About this study
Official title: A Phase II Trial of Safety and Efficacy of ADRCs Delivered Via the Intracoronary Route in the Treatment of Patients With ST-elevation Acute Myocardial Infarction - The ADVANCE Study
Double blind, prospective, randomized, placebo-controlled Safety and Efficacy trial of ADRCs delivered via the intracoronary route in the treatment of patients with ST-elevation acute myocardial infarction (STEMI).
Read the detailed description
This is a prospective, randomized, two arm, placebo-controlled, double blind, study that will enroll approximately 216 patients at no more than thirty-five (35) international clinical sites. Additional blinding measures will be taken in the assessment of study outcomes. The dose of the test material (ADRCs)is described in the protocol. The study will include two arms.
- Conditions
- Acute Myocardial Infarction
- Being tested
- Dose A, Placebo
- Keywords
- Heart Attack, Regenerative Cells, Stem Cells
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dose ABiological
Also called Adipose-Derived Regenerative Cells
ADRC Dose A
PlaceboBiological
Placebo Comparator
| Study group | Role | What they receive |
|---|---|---|
| Dose A | Active comparator | Dose A Receives: Biological: Dose A |
| Placebo | Placebo comparator | Placebo Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Infarct Size
Reduction in infarct size at 6 months as measured by cardiac MRI
Measured: 6 Months
Secondary outcomes (1)
MACCE Rates
Major Adverse Cardiac and Cerebral events (MACCE) is a composite clinical endpoint
Measured: Through 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2010 (estimated)
- Study startSep 2012
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cytori Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven Kesten, MD, Study director, Cytori Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01216995
- Sponsor's protocol ID
- ADVANCE
- Acronym
- ADVANCE
- Status last verified
- Nov 2014
- First submitted
- 6 Oct 2010
- Last updated
- 21 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Safety and Efficacy of ADRCs Delivered Via the Intracoronary Route in the Treatment of Patients With ST-elevation Acute Myocardial Infarction - The ADVANCE Study
- ClinicalTrials.gov ID
- NCT01216995
- Acronym / sponsor ID
- ADVANCE / ADVANCE
- Conditions
- Acute Myocardial Infarction
- Keywords
- Heart Attack, Regenerative Cells, Stem Cells
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Cytori TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 8 Oct 2010 (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.
Double blind, prospective, randomized, placebo-controlled Safety and Efficacy trial of ADRCs delivered via the intracoronary route in the treatment of patients with ST-elevation acute myocardial infarction (STEMI).
Detailed description
This is a prospective, randomized, two arm, placebo-controlled, double blind, study that will enroll approximately 216 patients at no more than thirty-five (35) international clinical sites. Additional blinding measures will be taken in the assessment of study outcomes. The dose of the test material (ADRCs)is described in the protocol. The study will include two arms.
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 |
|---|---|---|
| Dose A | Active comparator | Biological: Dose ADose A |
| Placebo | Placebo comparator | Biological: PlaceboPlacebo |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ST-segment Elevation Myocardial Infarction (STEMI) Criteria:
- Ischemic symptoms AND
- ECG:
- Development of pathologic Q waves on the ECG; or
- ECG changes indicative of severe ischemia (ST segment elevation and/or depression); or
Key exclusion criteria (5 listed)
- More than 24 hours between PCI and start of liposuction
- Prior myocardial infarction, cardiomyopathy, or a history of congestive heart failure
- Pacemaker, ICD, or any other contra-indication for MRI
- Patients with increased bleeding risk
- Cardiogenic shock present post-index PCI
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 |
|---|---|---|
| Dose AAlso: Adipose-Derived Regenerative CellsADRC Dose A | Biological | Dose A |
| PlaceboPlacebo Comparator | Biological | Placebo |
Primary outcome
Reduction in Infarct Size
Time frame: 6 Months
Reduction in infarct size at 6 months as measured by cardiac MRI
1 secondary outcome
MACCE Rates
Time frame: Through 36 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 21 Nov 2014.
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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.
Steven Kesten, MD study director
Cytori Therapeutics
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dose A in people with Acute Myocardial Infarction, run by Cytori Therapeutics at 4 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 8 inclusion and 5 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 21 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Poland, Netherlands. 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?
Reduction in Infarct Size (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 21 Nov 2014.