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

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ClinicalTrials.gov Identifier: NCT03043742
Recruitment Status : Recruiting
First Posted : February 6, 2017
Last Update Posted : April 9, 2019
Sponsor:
Information provided by (Responsible Party):
Michael Sekela, University of Kentucky

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.

Condition or disease Intervention/treatment Phase
Chronic Ischemic Heart Disease Drug: Bone Marrow Derived Autologous CD133+ Selected Cell Product Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 12, 2016
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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

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
Other Name: Stem cell




Primary Outcome Measures :
  1. Occurrence of Treatment-emergent serious adverse events (SAE) and adverse events [ Time Frame: Assess from Procedure through 12 months ]
    Major adverse cardiac event and adverse events defined in the common toxicity criteria


Secondary Outcome Measures :
  1. Change in left ventricular ejection fraction compared to baseline [ Time Frame: Assessed at baseline, 6 months, and 12 months ]
    Measured as a percentage by Echocardiography

  2. Change in myocardial regional function compared to baseline [ Time Frame: Assessed at baseline and 6 months ]
    Measured by nuclear scanning.

  3. Change in myocardial regional viability compared to baseline [ Time Frame: Assessed at baseline and 6 months ]
    Measured by nuclear scanning.

  4. Change in distance walked compared to baseline [ Time Frame: Assessed at baseline, 3 months, 6 months, and 12 months ]
    Measured in feet during a 6 minute walk test

  5. Change in quality of life associated with heart failure compared to baseline [ Time Frame: Assessed at baseline, 3 months, 6 months, and 12 months ]
    Measured using the Kansas City Cardiomyopathy Questionnaire.

  6. Change in class of angina compared to baseline [ Time Frame: Assessed at baseline, 3 months, 6 months, and 12 months. ]
    Measured using the Canadian Cardiovascular Society Grading Scale.

  7. Change in class of heart failure compared to baseline [ Time Frame: Assessed at baseline, 3 months, 6 months, and 12 months. ]
    Measured using the New York Heart Association Questionnaire

  8. Change in regional left ventricular wall motion compared to baseline [ Time Frame: Assessed at baseline, 6 months, and 12 months ]
    Measured using echocardiogram.

  9. Change in quality of life associated with angina compared to baseline [ Time Frame: Assessed at baseline, 3 months, 6 months, and 12 months ]
    Measured using the Seattle Angina Questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03043742


Contacts
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Contact: Connie Dampier, RN, MPA 859-323-1781 dampier@uky.edu
Contact: Michael Sekela, MD 859-323-6494 mese223@uky.edu

Locations
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United States, Kentucky
University of Kentucky Healthcare Recruiting
Lexington, Kentucky, United States, 40536
Contact: Michael Sekela, MD    859-323-6494    mese223@uky.edu   
Contact: Abdel Latif, MD    859-323-5479    abdel-latif@uky.edu   
Sponsors and Collaborators
Michael Sekela

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Responsible Party: Michael Sekela, Cardiothoracic Surgeon, University of Kentucky
ClinicalTrials.gov Identifier: NCT03043742     History of Changes
Other Study ID Numbers: 15-1051
First Posted: February 6, 2017    Key Record Dates
Last Update Posted: April 9, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: to be determined per principal investigator and statistician

Additional relevant MeSH terms:
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Ischemia
Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Pathologic Processes
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases