Clinical trial NCT00426868: A Randomized Clinical Trial of Adipose-derived Stem Cells in Treatment of Non Revascularizable Ischemic Myocardium
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Ischemic Heart Disease
Coronary Arteriosclerosis
Cardiovascular Disease
Coronary Disease
Coronary Artery Disease
Keywords: ADRC
Stem Cells
chronic ischemia
heart disease
coronary artery disease
inducible reversible ischemia
Lead sponsor: Cytori Therapeutics
Sponsor class: INDUSTRY
First posted: 2007-01-25
Enrollment: 27
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Safety - Determined by Major Adverse Cardiac and Cerebral Events (MACCE)
timeFrame: Up to 36 months
Secondary outcomes:
measure: Feasibility - Assessment of cardiac function using a variety of functional and imaging studies including MRI, SPECT and Echocardiography
timeFrame: Up to 36 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet University Hospital
city: Rotterdam
country: Netherlands
facility: Erasmus University Medical Centrum, Thorax Center
city: Utrecht
country: Netherlands
facility: University of Utrecht Medical Center
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
Study officials:
affiliation: Cytori Therapeutics, Inc
name: Alexander M Milstein, MD
role: STUDY_DIRECTOR
affiliation: Hospital G.U. Gregorio Marañón
name: Francisco J Fernández-Avilés, MD, PhD, FACC, FESC
role: PRINCIPAL_INVESTIGATOR
affiliation: Texas Heart Institute
name: Emerson C Perin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Perin EC, Sanz-Ruiz R, Sanchez PL, Lasso J, Perez-Cano R, Alonso-Farto JC, Perez-David E, Fernandez-Santos ME, Serruys PW, Duckers HJ, Kastrup J, Chamuleau S, Zheng Y, Silva GV, Willerson JT, Fernandez-Aviles F. Adipose-derived regenerative cells in patients with ischemic cardiomyopathy: The PRECISE Trial. Am Heart J. 2014 Jul;168(1):88-95.e2. doi: 10.1016/j.ahj.2014.03.022. Epub 2014 Apr 5.