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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

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).

Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Biological: Dose A Biological: Placebo Phase 2

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 : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : September 2012
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Active Comparator: Dose A
Dose A
Biological: Dose A
ADRC Dose A
Other Name: Adipose-Derived Regenerative Cells

Placebo Comparator: Placebo
Placebo
Biological: Placebo
Placebo Comparator




Primary Outcome Measures :
  1. Reduction in Infarct Size [ Time Frame: 6 Months ]
    Reduction in infarct size at 6 months as measured by cardiac MRI


Secondary Outcome Measures :
  1. MACCE Rates [ Time Frame: Through 36 months ]
    Major Adverse Cardiac and Cerebral events (MACCE) is a composite clinical endpoint



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01216995


Locations
Netherlands
Erasmus University Medical Centrum
Rotterdam, Netherlands
Poland
Krakowski Szpital Specjalistyczny im. Jana Pawla II Oddzial Kliniczny Chorob Serca i Naczyn
Krakow, Poland, 31202
Szpital Uniwersytecki Samodzielna Pracownia Zakladu Hemodynamiki
Krakow, Poland, 31501
Samodzielny Publiczny Centralny Szpital Kliniczny Pracownia Kardiologii Inwazyjnej
Warsaw, Poland, 02097
Sponsors and Collaborators
Cytori Therapeutics
Investigators
Study Director: Steven Kesten, MD Cytori Therapeutics

Responsible Party: Cytori Therapeutics
ClinicalTrials.gov Identifier: NCT01216995     History of Changes
Other Study ID Numbers: ADVANCE
First Posted: October 8, 2010    Key Record Dates
Last Update Posted: November 21, 2014
Last Verified: November 2014

Keywords provided by Cytori Therapeutics:
Heart Attack
Regenerative Cells
Stem Cells

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases