A Randomized Clinical Trial of Adipose-derived Stem Cells in Treatment of Non Revascularizable Ischemic Myocardium

Phase 1

Completed

• Conditions: Ischemic Heart Disease; Coronary Arteriosclerosis; Cardiovascular Disease; Coronary Disease; Coronary Artery Disease
• Interventions: Other: Direct injection of ADRCs into the Left Ventricle; Other: Direct injection of placebo into the Left Ventricle

• Registration Number: NCT00426868
• Lead Sponsor: Cytori Therapeutics

Brief Summary

The purpose of this study is to establish safety and feasibility of utilizing Adipose Derived Stem \& Regenerative Cells (ADRCs) in patients who have areas of myocardium that are not revascularizable and have demonstrated reversible ischemia.

Detailed Description

Subjects who have coronary artery disease that cannot be revascularized and demonstrate reversible ischemia in the area supplied by the non-revascularizable vessel(s) will be evaluated for eligibility in this study. Eligible subjects will undergo standard pre-operative testing after admission to the hospital, and then will undergo liposuction under anesthesia, after which ADRCs will be isolated from the lipoaspirate. According to randomization subjects will receive either ADRCs or placebo.

The outcomes of this trial will be based on assessment of primary and secondary endpoints at 6 months post index procedure. Long Term Follow-up will be conducted at 12, 18, 24 and 36 months after the procedure.

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-01-23
• Study First Submitted QC: 2007-01-24
• Study First Posted: 2007-01-25
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-27
• Last Update Posted: 2013-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

• Able to provide written informed consent
• Males or females 20 to 75 years of age, inclusive
• Coronary artery disease not amenable to any type of revascularization procedure (percutaneous or surgical) in the target area
• Hemodynamic stability
• Ability to undergo liposuction
• Ability to walk on a treadmill
• Negative urine pregnancy test (females only).

Key

Exclusion Criteria

• Unstable angina
• Serum creatinine >2.5 mg/dL
• Planned or scheduled staged treatment of CAD or other interventional or surgical procedures
• Cardiogenic shock
• History of resuscitated sudden cardiac death; or symptomatic or sustained ventricular fibrillation or ventricular tachycardia.
• Vascular anatomy that precludes cardiac catheterization
• Peripheral artery disease that precludes insertion of an 8 Fr sheath
• Severe valvular disease
• Pregnant or nursing females
• Known and relevant allergies or sensitivities
• Life expectancy <1 year
• Participation in any other clinical research study that has not reached its primary endpoint or otherwise would interfere with the subject's participation in this study
• Any concurrent disease or condition that, in the opinion of the investigator, would make the subject unsuitable for participation in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Direct injection of ADRCs into the Left Ventricle	-
Placebo	Direct injection of placebo into the Left Ventricle	-

Primary Outcome Measures

Name	Time	Method
Safety - Determined by Major Adverse Cardiac and Cerebral Events (MACCE)	Up to 36 months

Secondary Outcome Measures

Name	Time	Method
Feasibility - Assessment of cardiac function using a variety of functional and imaging studies including MRI, SPECT and Echocardiography	Up to 36 months

Trial Locations

Locations (4)

Rigshospitalet University Hospital; 🇩🇰 Copenhagen, Denmark

Erasmus University Medical Centrum, Thorax Center; 🇳🇱 Rotterdam, Netherlands

University of Utrecht Medical Center; 🇳🇱 Utrecht, Netherlands

Hospital General Universitario Gregorio Marañón; 🇪🇸 Madrid, Spain