NCT00426868

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Cytori Therapeutics · Industry
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ischemic Heart Disease
• Coronary Arteriosclerosis
• Cardiovascular Disease
• Coronary Disease
• Coronary Artery Disease

Interventions

Type	Name	Description
OTHER	Direct injection of ADRCs into the Left Ventricle	Dose escalation
OTHER	Direct injection of placebo into the Left Ventricle

Timeline

• Start date: 2007-01-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2007-01-25
• Last updated: 2013-08-28

Locations

4 sites across 3 countries: Denmark, Netherlands, Spain