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)

Phase 2

Completed

• Conditions: Acute Myocardial Infarction
• Interventions: Biological: Dose A; Biological: Placebo

• Registration Number: NCT01216995
• Lead Sponsor: 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).

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 Timeline

• Study First Submitted: 2010-10-06
• Study First Submitted QC: 2010-10-07
• Study First Posted: 2010-10-08
• Study Start: 2012-09
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-19
• Last Update Posted: 2014-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose A	Dose A	Dose A
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Reduction in Infarct Size	6 Months	Reduction in infarct size at 6 months as measured by cardiac MRI

Secondary Outcome Measures

Name	Time	Method
MACCE Rates	Through 36 months	Major Adverse Cardiac and Cerebral events (MACCE) is a composite clinical endpoint

Trial Locations

Locations (4)

Krakowski Szpital Specjalistyczny im. Jana Pawla II Oddzial Kliniczny Chorob Serca i Naczyn; 🇵🇱 Krakow, Poland

Samodzielny Publiczny Centralny Szpital Kliniczny Pracownia Kardiologii Inwazyjnej; 🇵🇱 Warsaw, Poland

Szpital Uniwersytecki Samodzielna Pracownia Zakladu Hemodynamiki; 🇵🇱 Krakow, Poland

Erasmus University Medical Centrum; 🇳🇱 Rotterdam, Netherlands