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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)

This study has been completed.
Information provided by (Responsible Party):
Cytori Therapeutics Identifier:
First received: October 6, 2010
Last updated: November 19, 2014
Last verified: November 2014
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 Intervention Phase
Acute Myocardial Infarction Biological: Dose A Biological: Placebo Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Cytori Therapeutics:

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

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

Enrollment: 23
Study Start Date: September 2012
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dose A
Dose A
Biological: Dose A
Other Name: Adipose-Derived Regenerative Cells
Placebo Comparator: Placebo
Biological: Placebo
Placebo Comparator

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.

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01216995

Erasmus University Medical Centrum
Rotterdam, Netherlands
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
Study Director: Steven Kesten, MD Cytori Therapeutics
  More Information

Responsible Party: Cytori Therapeutics Identifier: NCT01216995     History of Changes
Other Study ID Numbers: ADVANCE
Study First Received: October 6, 2010
Last Updated: November 19, 2014

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

Additional relevant MeSH terms:
Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases processed this record on September 25, 2017