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

Rigshospitalet

Status and phase

Completed

Phase 1

Conditions

Ischemic Heart Disease

Treatments

Combination Product: USPIO labeled MSC injection

Study type

Interventional

Funder types

Other

Identifiers

NCT03651791

USPIO-MSC1

Details and patient eligibility

About

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.

Full 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.

Enrollment

5 patients

Sex

All

Ages

30 to 80 years old

Volunteers

No 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