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

Sponsor

Cytori Therapeutics (Industry)

Overall Status

Completed

CT.gov ID

NCT00426868

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

6.8

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ischemic Heart Disease Coronary Arteriosclerosis Cardiovascular Disease Coronary Disease Coronary Artery Disease	Other: Direct injection of ADRCs into the Left Ventricle Other: Direct injection of placebo into the Left Ventricle	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

27 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Randomized Clinical Trial of adiPose-deRived stEm & Regenerative Cells In the Treatment of Patients With Non revaScularizable ischEmic Myocardium - The PRECISE Trial

Study Start Date :

Jan 1, 2007

Actual Primary Completion Date :

Mar 1, 2012

Actual Study Completion Date :

Mar 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment	Other: Direct injection of ADRCs into the Left Ventricle Dose escalation
Placebo Comparator: Placebo	Other: Direct injection of placebo into the Left Ventricle

Arm

Intervention/Treatment

Experimental: Treatment

Other: Direct injection of ADRCs into the Left Ventricle

Dose escalation

Placebo Comparator: Placebo

Other: Direct injection of placebo into the Left Ventricle

Outcome Measures

Primary Outcome Measures

Safety - Determined by Major Adverse Cardiac and Cerebral Events (MACCE) [Up to 36 months]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Key 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.

Contacts and Locations

Locations

	Site	City	Country
1	Rigshospitalet University Hospital	Copenhagen	Denmark
2	Erasmus University Medical Centrum, Thorax Center	Rotterdam	Netherlands
3	University of Utrecht Medical Center	Utrecht	Netherlands
4	Hospital General Universitario Gregorio Marañón	Madrid	Spain

Sponsors and Collaborators

Cytori Therapeutics

Investigators

Study Director: Alexander M Milstein, MD, Cytori Therapeutics, Inc
Principal Investigator: Francisco J Fernández-Avilés, MD, PhD, FACC, FESC, Hospital G.U. Gregorio Marañón
Principal Investigator: Emerson C Perin, MD, PhD, Texas Heart Institute