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

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00426868
• Other study ID #: PRECISE-01
• Status: Completed
• Phase: Phase 1
• First received: January 23, 2007
• Last updated: August 27, 2013
• Start date: January 2007
• Est. completion date: March 2012

Study information

• Verified date: August 2013
• Source: Cytori Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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.

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
• Heart Diseases
• Ischemia
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Other:
• Direct injection of ADRCs into the Left Ventricle
Dose escalation
• Direct injection of placebo into the Left Ventricle

Locations

Country	Name	City	State
Denmark	Rigshospitalet University Hospital	Copenhagen
Netherlands	Erasmus University Medical Centrum, Thorax Center	Rotterdam
Netherlands	University of Utrecht Medical Center	Utrecht
Spain	Hospital General Universitario Gregorio Marañón	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Cytori Therapeutics

Countries where clinical trial is conducted

Denmark,  Netherlands,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety - Determined by Major Adverse Cardiac and Cerebral Events (MACCE)		Up to 36 months	Yes
Secondary	Feasibility - Assessment of cardiac function using a variety of functional and imaging studies including MRI, SPECT and Echocardiography		Up to 36 months	No