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

Chronic Ischemic Heart Disease Clinical Trial

Official title:

Prospective Controlled Trial of Intra-Myocardial Infusion of Bone Marrow Derived Autologous CD133+ Selected Cells During Trans-Myocardial Laser Revascularization (TMR) in Patients With Chronic Ischemic Heart Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03043742
• Other study ID #: 15-1051
• Status: Completed
• Phase: Phase 1
• Start date: July 12, 2016
• Est. completion date: November 12, 2020

Study information

• Verified date: December 2020
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Multiple case experiences and studies have been published reviewing clinical experiences with Carbon Dioxide Trans-Myocardial Laser Revascularization (TMR) and autologous bone marrow derived cell application. These experiences have demonstrated perfusion improvements, ejection fraction improvements and improvements in angina or heart failure symptoms. The investigators elected to examine the use of CD133 positive (CD133+) BM-derived stem cells because of their pluripotent nature and the fact that during the CD133 selection process inflammatory cells present in the bone marrow are being discarded. CD133+ is a recently discovered marker for more primitive bone marrow derived multipotent stem and endothelial progenitor cells and is of particular interest in studies directed to therapeutic angiogenesis, as these cells have been shown to differentiate into endothelial and myogenic cell lines. Multiple studies have utilized BM derived cells for myocardial regeneration. Patients who received CD133+ cells showed improved perfusion at injection sites of stem cells leading to a significant increase in volume of left ventricular ejection fraction, regional wall motion in the infarct zone, and a reduction in end systolic left ventricular volume.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: November 12, 2020
• Est. primary completion date: November 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Ischemic Heart Disease
• Coronary Artery Disease
• Heart Diseases
• Ischemia
• Myocardial Ischemia

Intervention

Drug:
• Bone Marrow Derived Autologous CD133+ Selected Cell Product
Injection of bone marrow derived autologous CD133+ cell product into laser channels during Trans-Myocardial Revascularization

Locations

Country	Name	City	State
United States	University of Kentucky Healthcare	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Michael Sekela

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of Treatment-emergent serious adverse events (SAE) and adverse events	Major adverse cardiac event and adverse events defined in the common toxicity criteria	Assess from Procedure through 12 months
Secondary	Change in left ventricular ejection fraction compared to baseline	Measured as a percentage by Echocardiography	Assessed at baseline, 6 months, and 12 months
Secondary	Change in myocardial regional function compared to baseline	Measured by nuclear scanning.	Assessed at baseline and 6 months
Secondary	Change in myocardial regional viability compared to baseline	Measured by nuclear scanning.	Assessed at baseline and 6 months
Secondary	Change in distance walked compared to baseline	Measured in feet during a 6 minute walk test	Assessed at baseline, 3 months, 6 months, and 12 months
Secondary	Change in quality of life associated with heart failure compared to baseline	Measured using the Kansas City Cardiomyopathy Questionnaire.	Assessed at baseline, 3 months, 6 months, and 12 months
Secondary	Change in class of angina compared to baseline	Measured using the Canadian Cardiovascular Society Grading Scale.	Assessed at baseline, 3 months, 6 months, and 12 months.
Secondary	Change in class of heart failure compared to baseline	Measured using the New York Heart Association Questionnaire	Assessed at baseline, 3 months, 6 months, and 12 months.
Secondary	Change in regional left ventricular wall motion compared to baseline	Measured using echocardiogram.	Assessed at baseline, 6 months, and 12 months
Secondary	Change in quality of life associated with angina compared to baseline	Measured using the Seattle Angina Questionnaire	Assessed at baseline, 3 months, 6 months, and 12 months