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

NCT00442806 | Completed Phase 1 DMC

• 1 other identifier: APOLLO - 01
• Study Type: interventional
• Target: 14
• Locations: 2 countries
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

  6 months

Secondary Outcomes (1)

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

  6 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo is injected

Other: Injection of Placebo

Treatment

EXPERIMENTAL

ADRC's are injected

Drug: Injection of ADRC's

Interventions

Injection of ADRC's DRUG

ADRC's are injected

Treatment

Injection of Placebo OTHER

Placebo is injected

Placebo

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cytori Therapeutics: lead

Study Sites (2)

Erasmus University Medical Centrum, Thorax Center

Rotterdam, Netherlands

Location

Hospital General Universitario Gregorio Maranon

Madrid, 28007, Spain

Location

MeSH Terms

Conditions

Myocardial Infarction; Coronary Artery Disease; Cardiovascular Diseases; Coronary Disease; ST Elevation Myocardial Infarction; Heart Diseases

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Eric Duckers, MD, PhD

  Erasmus University Medical Centrum, ThoraxCenter

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2007
• First Posted: March 2, 2007
• Study Start: November 1, 2007
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: November 26, 2013

Record last verified: 2013-11

Locations

NL (1); ES (1)