Stem Cell Heart Injections During Laser Revascularization Surgery for Treatment of Chronic Ischemic Heart Disease
Completed · Phase 1
Conditions studied: Chronic Ischemic Heart Disease
In brief
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.
Key facts
- Study ID
- NCT03043742
- Run by
- Michael Sekela
- People needed
- 8
- Starts
- 2016-07-12
- Expected to finish
- 2020-11-12
- Last updated by the study team
- 2020-12-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Kentucky Healthcare — Lexington, Kentucky, United States
Full record on ClinicalTrials.gov
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