Status:
COMPLETED
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)
Lead Sponsor:
Cytori Therapeutics
Conditions:
Acute Myocardial Infarction
Eligibility:
All Genders
20-80 years
Phase:
PHASE2
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 infar...
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. Additiona...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
September 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT01216995
Start Date
September 1 2012
End Date
May 1 2014
Last Update
November 21 2014
Active Locations (4)
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1
Erasmus University Medical Centrum
Rotterdam, Netherlands
2
Krakowski Szpital Specjalistyczny im. Jana Pawla II Oddzial Kliniczny Chorob Serca i Naczyn
Krakow, Poland, 31202
3
Szpital Uniwersytecki Samodzielna Pracownia Zakladu Hemodynamiki
Krakow, Poland, 31501
4
Samodzielny Publiczny Centralny Szpital Kliniczny Pracownia Kardiologii Inwazyjnej
Warsaw, Poland, 02097