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)

Cytori Therapeutics23 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Acute Myocardial Infarction

Interventions

Dose ABIOLOGICAL

ADRC Dose A

PlaceboBIOLOGICAL

Placebo Comparator

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (4)

Erasmus University Medical Centrum

Rotterdam, Netherlands

Krakowski Szpital Specjalistyczny im. Jana Pawla II Oddzial Kliniczny Chorob Serca i Naczyn

Krakow, Poland

Szpital Uniwersytecki Samodzielna Pracownia Zakladu Hemodynamiki

Krakow, Poland

Samodzielny Publiczny Centralny Szpital Kliniczny Pracownia Kardiologii Inwazyjnej

Warsaw, Poland

Outcomes

Primary Outcomes

Reduction in Infarct Size

Reduction in infarct size at 6 months as measured by cardiac MRI

Time frame: 6 Months

Secondary Outcomes

MACCE Rates

Major Adverse Cardiac and Cerebral events (MACCE) is a composite clinical endpoint

Time frame: Through 36 months

Data from ClinicalTrials.gov

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