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Randomized Clinical Trial of Adipose-Derived Stem Cells in the Treatment of Pts With ST-elevation Myocardial Infarction

Primary Purpose

Myocardial Infarction, Coronary Arteriosclerosis, Cardiovascular Disease

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Injection of ADRC's
Injection of Placebo
Sponsored by
Cytori Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring ADRC, Stem Cells, Myocardial Infarction, STEMI, Heart Disease, Coronary Artery Disease, Coronary Disease, ST-Elevation, AMI, Interventional Cardiology, Heart Attack

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • Acute myocardial infarction (AMI)
  • Clinical symptoms consistent with AMI for a minimum of 2 and a maximum of 12 hours from onset of symptoms to Percutaneous Coronary Intervention (PCI), and unresponsive to nitroglycerin
  • Successful revascularization of the culprit lesion in the major epicardial vessel
  • Area of hypo- or akinesia corresponding to the culprit lesion, as determined by left ventriculogram at the time of primary PCI
  • Left ventricular ejection fraction (LVEF) ≥30% and ≤50% by Left Ventricular Angiography at the time of successful revascularization.
  • Ability to undergo liposuction

Key Exclusion Criteria:

  • Prior MI, prior known cardiomyopathy, or prior hospital admission for congestive heart failure (CHF)
  • More than 24 hours after acute PCI
  • Significant valvular disease
  • More than twelve hours between the onset of first symptoms of AMI and revascularization
  • Hemodynamic instability within 24 hours prior to randomization
  • Neoplasia
  • Acute or chronic bacterial or viral infectious disease
  • Pacemaker, ICD or any other contra-indication for MRI
  • LVEF <30% or >50% by Left Ventricular Angiography
  • Moderate or severe COPD

Sites / Locations

  • Erasmus University Medical Centrum, Thorax Center
  • Hospital General Universitario Gregorio Maranon

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Treatment

Arm Description

Placebo is injected

ADRC's are injected

Outcomes

Primary Outcome Measures

Safety - Determined by Major Adverse Cardiac and Cerebral Events (MACCE)

Secondary Outcome Measures

Feasibility - Assessment of cardiac function via functional and imaging studies including MRI, SPECT, and Echocardiography

Full Information

First Posted
February 28, 2007
Last Updated
November 25, 2013
Sponsor
Cytori Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT00442806
Brief Title
Randomized Clinical Trial of Adipose-Derived Stem Cells in the Treatment of Pts With ST-elevation Myocardial Infarction
Official Title
A Randomized Clinical Trial of AdiPOse-derived Stem ceLLs in the Treatment of Patients With ST-elevation myOcardial Infarction - The APOLLO Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cytori Therapeutics

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to establish safety and feasibility of utilizing Adipose-Derived Stem and Regenerative Cells (ADRC's) in patients who have suffered a ST-elevation acute myocardial infarction.
Detailed Description
Subjects who have coronary artery disease and have suffered a ST-elevation acute myocardial infarction will be evaluated for eligibility in this study. Eligible subjects will undergo standard treatment after admission to the hospital and will then undergo liposuction under local anesthesia, after which ADRC's will be isolated from the lipoaspirate. According to randomization subjects will receive either ADRC's or placebo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, Coronary Arteriosclerosis, Cardiovascular Disease, Coronary Disease
Keywords
ADRC, Stem Cells, Myocardial Infarction, STEMI, Heart Disease, Coronary Artery Disease, Coronary Disease, ST-Elevation, AMI, Interventional Cardiology, Heart Attack

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo is injected
Arm Title
Treatment
Arm Type
Experimental
Arm Description
ADRC's are injected
Intervention Type
Drug
Intervention Name(s)
Injection of ADRC's
Intervention Description
ADRC's are injected
Intervention Type
Other
Intervention Name(s)
Injection of Placebo
Intervention Description
Placebo is injected
Primary Outcome Measure Information:
Title
Safety - Determined by Major Adverse Cardiac and Cerebral Events (MACCE)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Feasibility - Assessment of cardiac function via functional and imaging studies including MRI, SPECT, and Echocardiography
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Acute myocardial infarction (AMI) Clinical symptoms consistent with AMI for a minimum of 2 and a maximum of 12 hours from onset of symptoms to Percutaneous Coronary Intervention (PCI), and unresponsive to nitroglycerin Successful revascularization of the culprit lesion in the major epicardial vessel Area of hypo- or akinesia corresponding to the culprit lesion, as determined by left ventriculogram at the time of primary PCI Left ventricular ejection fraction (LVEF) ≥30% and ≤50% by Left Ventricular Angiography at the time of successful revascularization. Ability to undergo liposuction Key Exclusion Criteria: Prior MI, prior known cardiomyopathy, or prior hospital admission for congestive heart failure (CHF) More than 24 hours after acute PCI Significant valvular disease More than twelve hours between the onset of first symptoms of AMI and revascularization Hemodynamic instability within 24 hours prior to randomization Neoplasia Acute or chronic bacterial or viral infectious disease Pacemaker, ICD or any other contra-indication for MRI LVEF <30% or >50% by Left Ventricular Angiography Moderate or severe COPD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Duckers, MD, PhD
Organizational Affiliation
Erasmus University Medical Centrum, ThoraxCenter
Official's Role
Principal Investigator
Facility Information:
Facility Name
Erasmus University Medical Centrum, Thorax Center
City
Rotterdam
Country
Netherlands
Facility Name
Hospital General Universitario Gregorio Maranon
City
Madrid
ZIP/Postal Code
28007
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

Randomized Clinical Trial of Adipose-Derived Stem Cells in the Treatment of Pts With ST-elevation Myocardial Infarction

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