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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)

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ClinicalTrials.gov Identifier: NCT01216995
Recruitment Status : Completed
First Posted : October 8, 2010
Last Update Posted : November 21, 2014
Sponsor:
Information provided by (Responsible Party):
Cytori Therapeutics

Tracking Information
First Submitted Date  ICMJE October 6, 2010
First Posted Date  ICMJE October 8, 2010
Last Update Posted Date November 21, 2014
Study Start Date  ICMJE September 2012
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 11, 2012)
Reduction in Infarct Size [ Time Frame: 6 Months ]
Reduction in infarct size at 6 months as measured by cardiac MRI
Original Primary Outcome Measures  ICMJE
 (submitted: October 7, 2010)
Reduction in Infarct Size [ Time Frame: 6 Months ]
Reduction in infarct size at 6 months, assessed by Gd contrast MRI and expressed as percent of left ventricle infarcted
Change History Complete list of historical versions of study NCT01216995 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2012)
MACCE Rates [ Time Frame: Through 36 months ]
Major Adverse Cardiac and Cerebral events (MACCE) is a composite clinical endpoint
Original Secondary Outcome Measures  ICMJE
 (submitted: October 7, 2010)
  • Reduction in Infarct Size [ Time Frame: 1 year ]
    Reduction in infarct size at 12 months, assessed by Gd contrast MRI and expressed as percent of left ventricle infarcted
  • MACCE Rates [ Time Frame: To 30 days, 180 days, and 360 days ]
    MACCE is a composite event comprised of the following:
    • Cardiac death
    • Myocardial infarction
    • Overnight hospitalization for heart failure which required administration of IV diuretics
    • Target lesion revascularization
    • Target vessel revascularization
    • CVA
    • Heart Failure
    • Improvement in perfusion (SPECT).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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)
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acute Myocardial Infarction
Intervention  ICMJE
  • Biological: Dose A
    ADRC Dose A
    Other Name: Adipose-Derived Regenerative Cells
  • Biological: Placebo
    Placebo Comparator
Study Arms  ICMJE
  • Active Comparator: Dose A
    Dose A
    Intervention: Biological: Dose A
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Biological: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 30, 2013)
23
Original Estimated Enrollment  ICMJE
 (submitted: October 7, 2010)
360
Actual Study Completion Date  ICMJE May 2014
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands,   Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01216995
Other Study ID Numbers  ICMJE ADVANCE
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cytori Therapeutics
Study Sponsor  ICMJE Cytori Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Steven Kesten, MD Cytori Therapeutics
PRS Account Cytori Therapeutics
Verification Date November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP