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)

Cytori Therapeutics

Status and phase

Completed

Phase 2

Conditions

Acute Myocardial Infarction

Treatments

Biological: Placebo

Biological: Dose A

Study type

Interventional

Funder types

Industry

Identifiers

NCT01216995

ADVANCE

Details and patient eligibility

About

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).

Full 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.

Enrollment

23 patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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