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)

November 19, 2014 updated by: Cytori Therapeutics

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

23

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Rotterdam, Netherlands
        • Erasmus University Medical Centrum
  • Poland
      • Krakow, Poland, 31202
        • Krakowski Szpital Specjalistyczny im. Jana Pawla II Oddzial Kliniczny Chorob Serca i Naczyn
      • Krakow, Poland, 31501
        • Szpital Uniwersytecki Samodzielna Pracownia Zakladu Hemodynamiki
      • Warsaw, Poland, 02097
        • Samodzielny Publiczny Centralny Szpital Kliniczny Pracownia Kardiologii Inwazyjnej

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Biological: Placebo
Placebo Comparator
ACTIVE_COMPARATOR: Dose A
Biological: Dose A
ADRC Dose A
Other Names:
  • Adipose-Derived Regenerative Cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in Infarct Size
Time Frame: 6 Months
Reduction in infarct size at 6 months as measured by cardiac MRI
6 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MACCE Rates
Time Frame: Through 36 months
Major Adverse Cardiac and Cerebral events (MACCE) is a composite clinical endpoint
Through 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cytori Therapeutics

Investigators

  • Study Director: Steven Kesten, MD, Cytori Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (ACTUAL)

May 1, 2014

Study Completion (ACTUAL)

May 1, 2014

Study Registration Dates

First Submitted

October 6, 2010

First Submitted That Met QC Criteria

October 7, 2010

First Posted (ESTIMATE)

October 8, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

November 21, 2014

Last Update Submitted That Met QC Criteria

November 19, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADVANCE (European Commission)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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