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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)

NCT ID: NCT01216995

Last Updated: 2014-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2014-05-31

Brief Summary

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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

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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

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Acute Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dose A

Dose A

Group Type ACTIVE_COMPARATOR

Dose A

Intervention Type BIOLOGICAL

ADRC Dose A

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Placebo Comparator

Interventions

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Dose A

ADRC Dose A

Intervention Type BIOLOGICAL

Placebo

Placebo Comparator

Intervention Type BIOLOGICAL

Other Intervention Names

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Adipose-Derived Regenerative Cells

Eligibility Criteria

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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

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cytori Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steven Kesten, MD

Role: STUDY_DIRECTOR

Cytori Therapeutics

Locations

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Erasmus University Medical Centrum

Rotterdam, , Netherlands

Site Status

Krakowski Szpital Specjalistyczny im. Jana Pawla II Oddzial Kliniczny Chorob Serca i Naczyn

Krakow, , Poland

Site Status

Szpital Uniwersytecki Samodzielna Pracownia Zakladu Hemodynamiki

Krakow, , Poland

Site Status

Samodzielny Publiczny Centralny Szpital Kliniczny Pracownia Kardiologii Inwazyjnej

Warsaw, , Poland

Site Status

Countries

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Netherlands Poland

Other Identifiers

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ADVANCE

Identifier Type: -

Identifier Source: org_study_id