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)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cytori Therapeutics
ClinicalTrials.gov Identifier:
NCT01216995
First received: October 6, 2010
Last updated: November 25, 2013
Last verified: November 2013

October 6, 2010
November 25, 2013
September 2012
May 2015   (final data collection date for primary outcome measure)
Reduction in Infarct Size [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
Reduction in infarct size at 6 months as measured by cardiac MRI
Reduction in Infarct Size [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
Reduction in infarct size at 6 months, assessed by Gd contrast MRI and expressed as percent of left ventricle infarcted
Complete list of historical versions of study NCT01216995 on ClinicalTrials.gov Archive Site
MACCE Rates [ Time Frame: Through 36 months ] [ Designated as safety issue: Yes ]
Major Adverse Cardiac and Cerebral events (MACCE) is a composite clinical endpoint
  • Reduction in Infarct Size [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]

    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).
Not Provided
Not Provided
 
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 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).

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Acute Myocardial Infarction
  • Biological: Dose A
    ADRC Dose A
    Other Name: Adipose-Derived Regenerative Cells
  • Biological: Placebo
    Placebo Comparator
    Other Name: Placebo
  • Active Comparator: Dose A
    Dose A
    Intervention: Biological: Dose A
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Biological: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
23
May 2015
May 2015   (final data collection date for primary outcome measure)

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
Both
20 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Netherlands,   Poland
 
NCT01216995
ADVANCE
Yes
Cytori Therapeutics
Cytori Therapeutics
Not Provided
Study Director: Steven Kesten, MD Cytori Therapeutics
Cytori Therapeutics
November 2013

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