In Vivo Tracking of USPIO Labeled MSC in the Heart

Launched by RIGSHOSPITALET, DENMARK · Aug 27, 2018

Keywords

ClinConnect Summary

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 percutan...

Gender

ALL

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