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

NCT ID: NCT03043742

Last Updated: 2020-12-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-12
• Study Completion Date: 2020-11-12

Brief 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.

Detailed 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.

Conditions

Chronic Ischemic Heart Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Phase I Open Label

open label bone marrow derived autologous CD133+ selected stem cell application in patients receiving trans-myocardial laser revascularization to improve regional myocardial function as detailed below:

Drug: CD133+ selected stem cells Dosage: Single injection of 0.1-0.2 ml around each laser channel Frequency: 10-20 channels Duration: Trans-Myocardial Revascularization

Group Type: EXPERIMENTAL

Bone Marrow Derived Autologous CD133+ Selected Cell Product

Intervention Type: DRUG

Injection of bone marrow derived autologous CD133+ cell product into laser channels during Trans-Myocardial Revascularization

Interventions

Bone Marrow Derived Autologous CD133+ Selected Cell Product

Injection of bone marrow derived autologous CD133+ cell product into laser channels during Trans-Myocardial Revascularization

Intervention Type: DRUG

Other Intervention Names

Stem cell

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Michael Sekela

OTHER

Sponsor Role: lead

Responsible Party

Michael Sekela

Cardiothoracic Surgeon

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Michael Sekela, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

University of Kentucky Healthcare

Lexington, Kentucky, United States

Countries

United States

Other Identifiers

15-1051

Identifier Type: -

Identifier Source: org_study_id