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
About this trial
This is an interventional treatment trial for Ischemic Heart Disease
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
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
NCT ID
NCT03651791
First Posted
August 23, 2018
Last Updated
August 27, 2018
Sponsor
Rigshospitalet, Denmark
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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