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)

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01216995

Acronym

ADVANCE

Enrollment

Registered

2010-10-08

Start date

2012-09-30

Completion date

2014-05-31

Last updated

2014-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myocardial Infarction

Keywords

Heart Attack, Regenerative Cells, Stem Cells

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.

Interventions

BIOLOGICALDose A

ADRC Dose A

BIOLOGICALPlacebo

Placebo Comparator

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

Inclusion 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

Design outcomes

Primary

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

Secondary

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

Countries

Netherlands, Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026