In Vivo Tracking of USPIO Labeled MSC in the Heart
- Conditions
- Ischemic Heart Disease
- Interventions
- Combination Product: USPIO labeled MSC injection
- Registration Number
- NCT03651791
- Lead Sponsor
- Rigshospitalet, Denmark
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 5
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description USPIO labeled MSC injection USPIO labeled MSC injection USPIO labeled MSC injection
- Primary Outcome Measures
Name Time Method MSC identification using MRI in-vivo on day 0 24 hours Being able to identify the iron-oxide labeled mesenchymal stromal cells on day 0 after injection into the myocardium by MRI.
- Secondary Outcome Measures
Name Time Method CCS class 26 weeks Canadian Cardiovascular Society (CCS) class after 26 weeks
MSC identification using MRI in-vivo on day 1 1 day Being able to identify the iron-oxide labeled mesenchymal stromal cells on day 1
MSC identification using MRI in-vivo on day 7 7 days Being able to identify the iron-oxide labeled mesenchymal stromal cells on day 7
MSC identification using MRI in-vivo after 2 weeks 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 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 8 weeks Being able to identify the iron-oxide labeled mesenchymal stromal cells after 8 weeks
Adverse events 6 months Adverse events registration
MSC identification using MRI in-vivo after 26 weeks 26 weeks Being able to identify the iron-oxide labeled mesenchymal stromal cells after 26 weeks
Seattle Angina Questionnaire 26 weeks Seattle Angina Questionnaire after 26 weeks
Weekly nitroglycerin consumption 26 weeks Weekly nitroglycerin consumption after 26 weeks
Cardiac pump function changes 26 weeks Left ventricular ejection fraction, systolic and diastolic volumes after 26 weeks
Weekly number of angina attacks 26 weeks Weekly number of angina attacks after 26 weeks
MSC identification using MRI in-vivo after 12 weeks 12 weeks Being able to identify the iron-oxide labeled mesenchymal stromal cells after 12 weeks