Stem Cell Heart Injections During Laser Revascularization Surgery for Treatment of Chronic Ischemic Heart Disease

• Status: Completed
• Trial end date: 2020-11-12
• Target enrollment: 0
• Participant gender: All

Summary

Assess the safety and effectiveness of stem cell application with regard to improvement in regional myocardial function in patients receiving Trans-Myocardial Laser Revascularization (TMR) and stem cells.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Michael Sekela

Criteria

Inclusion Criteria:

• Presence of at least two vessel coronary artery disease not amenable to direct revascularization

• Area of interest defined as part of free left ventricular vall with reduced contractility

• Demonstration of reduced perfusion in the area of interest (>30% of free wall)

• Global ejection fraction 30-45% with symptoms class >_ II on the NYHA scale

• Significant refractory angina defined as symptoms class >_ III that are refractory to maximal medical and anti-angina therapy

• Expected survival of at least two years

Exclusion Criteria:

• Any condition that prevents successful stem cell collection or application, e.g. systemic infection, puncture for stem cell collection impossible

• Any condition that may adversely affect bone marrow such as malignancy or prior irradiation to the pelvic bone

• Mitral valve insufficiency > moderate grade

• History of ventricular arrhythmias not controlled by medication and/or AICD

• Need for additional heart surgery (i.e. valve replacement)

• Emergency or salvage operation defined as within 48 hours of diagnosis

• Evidence of left ventricular thrombus

• Previous heart surgery within the last 6 months

• Increased Troponin T (> 3X ULN) in patients with unstable angina at time of intervention

• History of symptomatic carotid disease within the last 3 months prior to study intervention

• Ejection fraction < 30%

• End stage renal disease

• Untreatable cancer, current or within preceding 5 years

• Severe COPD