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
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
    Reduction in infarct size at 6 months as measured by cardiac MRI


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


Enrollment: 23
Study Start Date: September 2012
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Placebo

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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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
  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 ClinicalTrials.gov identifier: NCT01216995

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

No publications provided

Responsible Party: Cytori Therapeutics
ClinicalTrials.gov Identifier: NCT01216995     History of Changes
Other Study ID Numbers: ADVANCE
Study First Received: October 6, 2010
Last Updated: November 25, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Poland: Office for the Registration of Medical Products, Medical Devices and Biocidal Products

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

ClinicalTrials.gov processed this record on September 18, 2014