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)

Acute Myocardial Infarction Clinical Trial

— ADVANCE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01216995
• Other study ID #: ADVANCE
• Status: Completed
• Phase: Phase 2
• First received: October 6, 2010
• Last updated: November 19, 2014
• Start date: September 2012
• Est. completion date: May 2014

Study information

• Verified date: November 2014
• Source: Cytori Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)Poland: Office for the Registration of Medical Products, Medical Devices and Biocidal Products
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Biological:
• Dose A
ADRC Dose A
• Placebo
Placebo Comparator

Locations

Country	Name	City	State
Netherlands	Erasmus University Medical Centrum	Rotterdam
Poland	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

Sponsors (1)

Lead Sponsor	Collaborator
Cytori Therapeutics

Countries where clinical trial is conducted

Netherlands,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in Infarct Size	Reduction in infarct size at 6 months as measured by cardiac MRI	6 Months	No
Secondary	MACCE Rates	Major Adverse Cardiac and Cerebral events (MACCE) is a composite clinical endpoint	Through 36 months	Yes