NCT01216995

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Cytori Therapeutics · Industry
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Myocardial Infarction

Interventions

Type	Name	Description
BIOLOGICAL	Dose A	ADRC Dose A
BIOLOGICAL	Placebo	Placebo Comparator

Timeline

• Start date: 2012-09-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2010-10-08
• Last updated: 2014-11-21

Locations

4 sites across 2 countries: Netherlands, Poland