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In Vivo Tracking of USPIO Labeled MSC in the Heart (USPIO-MSC)

Primary Purpose

Ischemic Heart Disease

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
USPIO labeled MSC injection
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Heart Disease

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age between 30 and 80 years.
  • Signed informed consent.
  • Chronic stable ischemic heart disease
  • New York Heart Association (NYHA) class II-IV or Canadian Cardiovascular Society (CCS) class II-IV
  • Maximal tolerable angina and/or heart failure medication.
  • Angiography within 12 months of inclusion. Angiography must have at least one larger coronary vessel with a significant stenosis with no option for revascularization (Angiographies evaluated by an independent thoracic surgeon and an interventional cardiologist).
  • Patients who have had revascularization done within 6 months of inclusion must have a new angiography at least 4 months after the intervention to rule out early restenosis.

Exclusion Criteria:

  • Pregnant or fertile women.
  • Clinical significant anemia, leukopenia, leukocytosis or thrombocythemia.
  • Diminished functional capacity for other reasons such as: chronic obstructive pulmonary disease (COLD) with Forced Expiratory Volume in 1 second (FEV1)<1 L/min, moderate to severe claudication or morbid obesity.
  • Patients with reduced immune response or treated with immunosuppressive medication.
  • Moderate to severe valvular disease or valvular disease with option for valvular surgery.
  • Acute coronary syndrome with elevation of coronary markers, stroke or Transitory Cerebral Ischemia (TCI) within 6 weeks of inclusion.
  • History with malignant disease within 5 years of inclusion or suspected malignity.
  • Other experimental treatment within 4 weeks of baseline evaluation.
  • Other revascularization treatment within 4 months of treatment.
  • Contraindications for Magnetic Resonance Imaging (MRI) such as: Claustrophobia, pacemaker, Implantable Cardioverter Defibrillator (ICD) unit, metal fragments or metal implants in the cranium

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    USPIO labeled MSC injection

    Arm Description

    USPIO labeled MSC injection

    Outcomes

    Primary Outcome Measures

    MSC identification using MRI in-vivo on day 0
    Being able to identify the iron-oxide labeled mesenchymal stromal cells on day 0 after injection into the myocardium by MRI.

    Secondary Outcome Measures

    MSC identification using MRI in-vivo on day 1
    Being able to identify the iron-oxide labeled mesenchymal stromal cells on day 1
    MSC identification using MRI in-vivo on day 7
    Being able to identify the iron-oxide labeled mesenchymal stromal cells on day 7
    MSC identification using MRI in-vivo after 2 weeks
    Being able to identify the iron-oxide labeled mesenchymal stromal cells after 2 weeks
    MSC identification using MRI in-vivo after 4 weeks
    Being able to identify the iron-oxide labeled mesenchymal stromal cells after 4 weeks
    MSC identification using MRI in-vivo after 8 weeks
    Being able to identify the iron-oxide labeled mesenchymal stromal cells after 8 weeks
    MSC identification using MRI in-vivo after 12 weeks
    Being able to identify the iron-oxide labeled mesenchymal stromal cells after 12 weeks
    MSC identification using MRI in-vivo after 26 weeks
    Being able to identify the iron-oxide labeled mesenchymal stromal cells after 26 weeks
    Cardiac pump function changes
    Left ventricular ejection fraction, systolic and diastolic volumes after 12 weeks
    Cardiac pump function changes
    Left ventricular ejection fraction, systolic and diastolic volumes after 26 weeks
    CCS class
    Canadian Cardiovascular Society (CCS) class after 12 weeks
    CCS class
    Canadian Cardiovascular Society (CCS) class after 26 weeks
    Seattle Angina Questionnaire
    Seattle Angina Questionnaire after 12 weeks
    Seattle Angina Questionnaire
    Seattle Angina Questionnaire after 26 weeks
    Weekly number of angina attacks
    Weekly number of angina attacks after 12 weeks
    Weekly number of angina attacks
    Weekly number of angina attacks after 26 weeks
    Weekly nitroglycerin consumption
    Weekly nitroglycerin consumption after 12 weeks
    Weekly nitroglycerin consumption
    Weekly nitroglycerin consumption after 26 weeks
    Adverse events
    Adverse events registration

    Full Information

    First Posted
    August 23, 2018
    Last Updated
    August 27, 2018
    Sponsor
    Rigshospitalet, Denmark
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03651791
    Brief Title
    In Vivo Tracking of USPIO Labeled MSC in the Heart
    Acronym
    USPIO-MSC
    Official Title
    In Vivo MRI Tracking of Mesenchymal Stromal Cells Labeled With Ultra-Small Paramagnetic Iron Oxide Particles After Intramyocardial Transplantation in Patients With Chronic Ischemic Heart Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2013 (Actual)
    Primary Completion Date
    June 2014 (Actual)
    Study Completion Date
    October 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Rigshospitalet, Denmark

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    To evaluate the ability to trace iron oxide-labeled mesenchymal stromal cells with magnetic resonance imaging (MRI) after NOGA-guided injection therapy into the myocardium in patients with ischemic heart disease.
    Detailed Description
    Aims: To evaluate the ability to trace iron oxide-labeled mesenchymal stromal cells with magnetic resonance imaging (MRI) after NOGA-guided injection therapy into the myocardium. To evaluate the safety and efficacy of treatment with iron oxide-labeled mesenchymal stromal cells to form new heart muscle cells and blood vessels in the myocardium submitted by NOGA-guided injection therapy in the myocardium in order to improve myocardial blood flow and reduce patients' symptoms. Patient Population: Patients with coronary artery disease not treatable with additional bypass surgery or percutaneous coronary intervention who have angina pectoris (Canadian Cardiovascular Society (CCS) class II-III) or angina equivalent shortness of breath (New York Heart Association (NYHA) class II -III). Study Design A prospective, non-randomized, pilot study including 5-10 patients. Patients will by means of the percutaneous NOGA injection catheter system receive 12-15 intramyocardial injections. The number depending on the amount of cultured cells and distributed uniformly in the peripheral zone of a presumed ischemic area in the left ventricle demonstrated by angiography, magnetic resonance imaging and NOGA mapping.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    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
    5 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    USPIO labeled MSC injection
    Arm Type
    Experimental
    Arm Description
    USPIO labeled MSC injection
    Intervention Type
    Combination Product
    Intervention Name(s)
    USPIO labeled MSC injection
    Intervention Description
    USPIO labeled MSC injection
    Primary Outcome Measure Information:
    Title
    MSC identification using MRI in-vivo on day 0
    Description
    Being able to identify the iron-oxide labeled mesenchymal stromal cells on day 0 after injection into the myocardium by MRI.
    Time Frame
    24 hours
    Secondary Outcome Measure Information:
    Title
    MSC identification using MRI in-vivo on day 1
    Description
    Being able to identify the iron-oxide labeled mesenchymal stromal cells on day 1
    Time Frame
    1 day
    Title
    MSC identification using MRI in-vivo on day 7
    Description
    Being able to identify the iron-oxide labeled mesenchymal stromal cells on day 7
    Time Frame
    7 days
    Title
    MSC identification using MRI in-vivo after 2 weeks
    Description
    Being able to identify the iron-oxide labeled mesenchymal stromal cells after 2 weeks
    Time Frame
    2 weeks
    Title
    MSC identification using MRI in-vivo after 4 weeks
    Description
    Being able to identify the iron-oxide labeled mesenchymal stromal cells after 4 weeks
    Time Frame
    4 weeks
    Title
    MSC identification using MRI in-vivo after 8 weeks
    Description
    Being able to identify the iron-oxide labeled mesenchymal stromal cells after 8 weeks
    Time Frame
    8 weeks
    Title
    MSC identification using MRI in-vivo after 12 weeks
    Description
    Being able to identify the iron-oxide labeled mesenchymal stromal cells after 12 weeks
    Time Frame
    12 weeks
    Title
    MSC identification using MRI in-vivo after 26 weeks
    Description
    Being able to identify the iron-oxide labeled mesenchymal stromal cells after 26 weeks
    Time Frame
    26 weeks
    Title
    Cardiac pump function changes
    Description
    Left ventricular ejection fraction, systolic and diastolic volumes after 12 weeks
    Time Frame
    12 weeks
    Title
    Cardiac pump function changes
    Description
    Left ventricular ejection fraction, systolic and diastolic volumes after 26 weeks
    Time Frame
    26 weeks
    Title
    CCS class
    Description
    Canadian Cardiovascular Society (CCS) class after 12 weeks
    Time Frame
    12 weeks
    Title
    CCS class
    Description
    Canadian Cardiovascular Society (CCS) class after 26 weeks
    Time Frame
    26 weeks
    Title
    Seattle Angina Questionnaire
    Description
    Seattle Angina Questionnaire after 12 weeks
    Time Frame
    12 weeks
    Title
    Seattle Angina Questionnaire
    Description
    Seattle Angina Questionnaire after 26 weeks
    Time Frame
    26 weeks
    Title
    Weekly number of angina attacks
    Description
    Weekly number of angina attacks after 12 weeks
    Time Frame
    12 weeks
    Title
    Weekly number of angina attacks
    Description
    Weekly number of angina attacks after 26 weeks
    Time Frame
    26 weeks
    Title
    Weekly nitroglycerin consumption
    Description
    Weekly nitroglycerin consumption after 12 weeks
    Time Frame
    12 weeks
    Title
    Weekly nitroglycerin consumption
    Description
    Weekly nitroglycerin consumption after 26 weeks
    Time Frame
    26 weeks
    Title
    Adverse events
    Description
    Adverse events registration
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age between 30 and 80 years. Signed informed consent. Chronic stable ischemic heart disease New York Heart Association (NYHA) class II-IV or Canadian Cardiovascular Society (CCS) class II-IV Maximal tolerable angina and/or heart failure medication. Angiography within 12 months of inclusion. Angiography must have at least one larger coronary vessel with a significant stenosis with no option for revascularization (Angiographies evaluated by an independent thoracic surgeon and an interventional cardiologist). Patients who have had revascularization done within 6 months of inclusion must have a new angiography at least 4 months after the intervention to rule out early restenosis. Exclusion Criteria: Pregnant or fertile women. Clinical significant anemia, leukopenia, leukocytosis or thrombocythemia. Diminished functional capacity for other reasons such as: chronic obstructive pulmonary disease (COLD) with Forced Expiratory Volume in 1 second (FEV1)<1 L/min, moderate to severe claudication or morbid obesity. Patients with reduced immune response or treated with immunosuppressive medication. Moderate to severe valvular disease or valvular disease with option for valvular surgery. Acute coronary syndrome with elevation of coronary markers, stroke or Transitory Cerebral Ischemia (TCI) within 6 weeks of inclusion. History with malignant disease within 5 years of inclusion or suspected malignity. Other experimental treatment within 4 weeks of baseline evaluation. Other revascularization treatment within 4 months of treatment. Contraindications for Magnetic Resonance Imaging (MRI) such as: Claustrophobia, pacemaker, Implantable Cardioverter Defibrillator (ICD) unit, metal fragments or metal implants in the cranium
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jens Kastrup, MD DMSc
    Organizational Affiliation
    The Heart Centre, Rigshospitalet, University of Copenhagen
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    23577035
    Citation
    Mathiasen AB, Hansen L, Friis T, Thomsen C, Bhakoo K, Kastrup J. Optimal labeling dose, labeling time, and magnetic resonance imaging detection limits of ultrasmall superparamagnetic iron-oxide nanoparticle labeled mesenchymal stromal cells. Stem Cells Int. 2013;2013:353105. doi: 10.1155/2013/353105. Epub 2013 Mar 19.
    Results Reference
    background
    PubMed Identifier
    24734781
    Citation
    Hansen L, Hansen AB, Mathiasen AB, Ng M, Bhakoo K, Ekblond A, Kastrup J, Friis T. Ultrastructural characterization of mesenchymal stromal cells labeled with ultrasmall superparamagnetic iron-oxide nanoparticles for clinical tracking studies. Scand J Clin Lab Invest. 2014 Aug;74(5):437-46. doi: 10.3109/00365513.2014.900698. Epub 2014 Apr 15.
    Results Reference
    background
    PubMed Identifier
    31814830
    Citation
    Mathiasen AB, Qayyum AA, Jorgensen E, Helqvist S, Ekblond A, Ng M, Bhakoo K, Kastrup J. In Vivo MRI Tracking of Mesenchymal Stromal Cells Labeled with Ultrasmall Paramagnetic Iron Oxide Particles after Intramyocardial Transplantation in Patients with Chronic Ischemic Heart Disease. Stem Cells Int. 2019 Nov 14;2019:2754927. doi: 10.1155/2019/2754927. eCollection 2019.
    Results Reference
    derived

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    In Vivo Tracking of USPIO Labeled MSC in the Heart

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