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Trial record 93 of 1835 for:    "bone marrow" | Recruiting, Not yet recruiting Studies

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

Tracking Information
First Submitted Date  ICMJE June 17, 2016
First Posted Date  ICMJE February 6, 2017
Last Update Posted Date April 9, 2019
Actual Study Start Date  ICMJE July 12, 2016
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 2, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 2, 2017)
  • 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
  • Change in myocardial regional function compared to baseline [ Time Frame: Assessed at baseline and 6 months ]
    Measured by nuclear scanning.
  • Change in myocardial regional viability compared to baseline [ Time Frame: Assessed at baseline and 6 months ]
    Measured by nuclear scanning.
  • 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
  • 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.
  • 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.
  • 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
  • Change in regional left ventricular wall motion compared to baseline [ Time Frame: Assessed at baseline, 6 months, and 12 months ]
    Measured using echocardiogram.
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Stem Cell Heart Injections During Laser Revascularization Surgery for Treatment of Chronic Ischemic Heart Disease
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Ischemic Heart Disease
Intervention  ICMJE 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
Study Arms  ICMJE 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

Intervention: Drug: Bone Marrow Derived Autologous CD133+ Selected Cell Product
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 2, 2017)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2021
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Connie Dampier, RN, MPA 859-323-1781 dampier@uky.edu
Contact: Michael Sekela, MD 859-323-6494 mese223@uky.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03043742
Other Study ID Numbers  ICMJE 15-1051
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: to be determined per principal investigator and statistician
Responsible Party Michael Sekela, University of Kentucky
Study Sponsor  ICMJE Michael Sekela
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Kentucky
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP