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

Myocardial Infarction Clinical Trial

Official title:

A Randomized Clinical Trial of AdiPOse-derived Stem ceLLs in the Treatment of Patients With ST-elevation myOcardial Infarction - The APOLLO Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00442806
• Other study ID #: APOLLO - 01
• Status: Completed
• Phase: Phase 1
• First received: February 28, 2007
• Last updated: November 25, 2013
• Start date: November 2007
• Est. completion date: April 2012

Study information

• Verified date: November 2013
• Source: Cytori Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)Spain: Agencia Espanola de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Arteriosclerosis
• Cardiovascular Disease
• Cardiovascular Diseases
• Coronary Arteriosclerosis
• Coronary Artery Disease
• Coronary Disease
• Infarction
• Myocardial Infarction
• Myocardial Ischemia

Intervention

Drug:
• Injection of ADRC's
ADRC's are injected

Other:
• Injection of Placebo
Placebo is injected

Locations

Country	Name	City	State
Netherlands	Erasmus University Medical Centrum, Thorax Center	Rotterdam
Spain	Hospital General Universitario Gregorio Maranon	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Cytori Therapeutics

Countries where clinical trial is conducted

Netherlands,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety - Determined by Major Adverse Cardiac and Cerebral Events (MACCE)		6 months	Yes
Secondary	Feasibility - Assessment of cardiac function via functional and imaging studies including MRI, SPECT, and Echocardiography		6 months	No