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

Primary Purpose

Chronic Ischemic Heart Disease

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Bone Marrow Derived Autologous CD133+ Selected Cell Product

About this trial

This is an interventional treatment trial for Chronic Ischemic Heart Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Kentucky Healthcare

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Phase I Open Label

Arm Description

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

Outcomes

Primary Outcome Measures

Occurrence of Treatment-emergent serious adverse events (SAE) and adverse events

Major adverse cardiac event and adverse events defined in the common toxicity criteria

Secondary Outcome Measures

Change in left ventricular ejection fraction compared to baseline

Measured as a percentage by Echocardiography

Change in myocardial regional function compared to baseline

Measured by nuclear scanning.

Change in myocardial regional viability compared to baseline

Measured by nuclear scanning.

Change in distance walked compared to baseline

Measured in feet during a 6 minute walk test

Change in quality of life associated with heart failure compared to baseline

Measured using the Kansas City Cardiomyopathy Questionnaire.

Change in class of angina compared to baseline

Measured using the Canadian Cardiovascular Society Grading Scale.

Change in class of heart failure compared to baseline

Measured using the New York Heart Association Questionnaire

Change in regional left ventricular wall motion compared to baseline

Measured using echocardiogram.

Change in quality of life associated with angina compared to baseline

Measured using the Seattle Angina Questionnaire

Full Information

NCT ID

NCT03043742

First Posted

June 17, 2016

Last Updated

December 9, 2020

Sponsor

Michael Sekela

1. Study Identification

Unique Protocol Identification Number

NCT03043742

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Completed

Study Start Date

July 12, 2016 (Actual)

Primary Completion Date

November 12, 2020 (Actual)

Study Completion Date

November 12, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Michael Sekela

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Ischemic Heart Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Phase I Open Label

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Bone Marrow Derived Autologous CD133+ Selected Cell Product

Other Intervention Name(s)

Stem cell

Intervention Description

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

Primary Outcome Measure Information:

Title

Occurrence of Treatment-emergent serious adverse events (SAE) and adverse events

Description

Major adverse cardiac event and adverse events defined in the common toxicity criteria

Time Frame

Assess from Procedure through 12 months

Secondary Outcome Measure Information:

Title

Change in left ventricular ejection fraction compared to baseline

Description

Measured as a percentage by Echocardiography

Time Frame

Assessed at baseline, 6 months, and 12 months

Title

Change in myocardial regional function compared to baseline

Description

Measured by nuclear scanning.

Time Frame

Assessed at baseline and 6 months

Title

Change in myocardial regional viability compared to baseline

Description

Measured by nuclear scanning.

Time Frame

Assessed at baseline and 6 months

Title

Change in distance walked compared to baseline

Description

Measured in feet during a 6 minute walk test

Time Frame

Assessed at baseline, 3 months, 6 months, and 12 months

Title

Change in quality of life associated with heart failure compared to baseline

Description

Measured using the Kansas City Cardiomyopathy Questionnaire.

Time Frame

Assessed at baseline, 3 months, 6 months, and 12 months

Title

Change in class of angina compared to baseline

Description

Measured using the Canadian Cardiovascular Society Grading Scale.

Time Frame

Assessed at baseline, 3 months, 6 months, and 12 months.

Title

Change in class of heart failure compared to baseline

Description

Measured using the New York Heart Association Questionnaire

Time Frame

Assessed at baseline, 3 months, 6 months, and 12 months.

Title

Change in regional left ventricular wall motion compared to baseline

Description

Measured using echocardiogram.

Time Frame

Assessed at baseline, 6 months, and 12 months

Title

Change in quality of life associated with angina compared to baseline

Description

Measured using the Seattle Angina Questionnaire

Time Frame

Assessed at baseline, 3 months, 6 months, and 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael Sekela, MD

Organizational Affiliation

University of Kentucky

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Kentucky Healthcare

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40536

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

to be determined per principal investigator and statistician

Learn more about this trial

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

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