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) (ADVANCE)
Primary Purpose
Acute Myocardial Infarction
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Dose A
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring Heart Attack, Regenerative Cells, Stem Cells
Eligibility Criteria
Key Inclusion Criteria:
- 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
Key Exclusion Criteria:
- 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
Sites / Locations
- Erasmus University Medical Centrum
- Krakowski Szpital Specjalistyczny im. Jana Pawla II Oddzial Kliniczny Chorob Serca i Naczyn
- Szpital Uniwersytecki Samodzielna Pracownia Zakladu Hemodynamiki
- Samodzielny Publiczny Centralny Szpital Kliniczny Pracownia Kardiologii Inwazyjnej
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Dose A
Placebo
Arm Description
Dose A
Placebo
Outcomes
Primary Outcome Measures
Reduction in Infarct Size
Reduction in infarct size at 6 months as measured by cardiac MRI
Secondary Outcome Measures
MACCE Rates
Major Adverse Cardiac and Cerebral events (MACCE) is a composite clinical endpoint
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01216995
Brief Title
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)
Acronym
ADVANCE
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cytori Therapeutics
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
Keywords
Heart Attack, Regenerative Cells, Stem Cells
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dose A
Arm Type
Active Comparator
Arm Description
Dose A
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Biological
Intervention Name(s)
Dose A
Other Intervention Name(s)
Adipose-Derived Regenerative Cells
Intervention Description
ADRC Dose A
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Placebo Comparator
Primary Outcome Measure Information:
Title
Reduction in Infarct Size
Description
Reduction in infarct size at 6 months as measured by cardiac MRI
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
MACCE Rates
Description
Major Adverse Cardiac and Cerebral events (MACCE) is a composite clinical endpoint
Time Frame
Through 36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
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
Key Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Kesten, MD
Organizational Affiliation
Cytori Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Erasmus University Medical Centrum
City
Rotterdam
Country
Netherlands
Facility Name
Krakowski Szpital Specjalistyczny im. Jana Pawla II Oddzial Kliniczny Chorob Serca i Naczyn
City
Krakow
ZIP/Postal Code
31202
Country
Poland
Facility Name
Szpital Uniwersytecki Samodzielna Pracownia Zakladu Hemodynamiki
City
Krakow
ZIP/Postal Code
31501
Country
Poland
Facility Name
Samodzielny Publiczny Centralny Szpital Kliniczny Pracownia Kardiologii Inwazyjnej
City
Warsaw
ZIP/Postal Code
02097
Country
Poland
12. IPD Sharing Statement
Learn more about this trial
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)
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