Stem Cell Therapy in IschEmic Non-treatable Cardiac Disease (SCIENCE)

JKastrup

Status and phase

Completed

Phase 2

Conditions

Heart Failure

Treatments

Biological: CSCC_ASC

Study type

Interventional

Funder types

Other

Identifiers

NCT02673164

SCIENCE

Details and patient eligibility

About

The aim of the SCIENCE study is, in an international multicentre double-blind placebo-controlled study, to investigate efficacy of direct intra-myocardial injection of 100 mio. allogeneic Cardiology Stem Cell Centre_adipose derived stem cells (CSCC_ASCs) in patients with reduced left ventricular Ejection Fraction (EF) (≤45%) and heart failure.

Full description

The primary objective is to investigate the regenerative capacity of direct intra-myocardial injection of 100 mio. allogeneic CSCC_ASCs in patients with reduced left ventricular EF (≤45%) and heart failure in a double-blind placebo-controlled design.

A total of 138 patients with will be enrolled in the study and treated in a 2:1 randomization with either CSCC_ASC or placebo (saline).

Enrollment

133 patients

Sex

All

Ages

30 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

30 to 80 years of age
Signed informed consent
Chronic stable ischemic heart disease
Symptomatic heart failure New York Heart Association (NYHA) class II-III
EF ≤ 45% on echocardiography, Computerized Tomography (CT) or Magnetic Resonances Imaging (MRI) scan
Plasma NT-pro-BNP > 300 pg/ml (> 35 pmol/L)
Maximal tolerable heart failure medication
Heart failure medication unchanged two months prior to inclusion. Changes in diuretics accepted.
No option for percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)
Patients who have had PCI or CABG within six months of inclusion must have a new coronary angiography less than one month before inclusion or at least four months after the intervention to rule out early restenosis
Patients cannot be included until three months after implantation of a cardiac resynchronisation therapy device (CRTD) and until 1 month after an ICD unit

Exclusion criteria

Heart Failure (NYHA class I or IV)
Acute coronary syndrome with acute reversible elevation of CKMB or troponins, stroke or transitory cerebral ischemia within six weeks of inclusion. Constant elevated troponin due to renal failure, heart failure etc. do not exclude the patient.
Other revascularisation treatment within four months of treatment
If clinically indicated the patient should have a coronary angiography before inclusion
Moderate to severe aortic stenosis (valve area < 1.3 cm2) or valvular disease with option for surgery or interventional therapy.
Aortic valve replacement with an artificial heart valve. However, a trans-septal treatment approach can be considered in these patients.
If the patient is expected to be candidate for MitraClip therapy of mitral regurgitation in the 12 months follow-up period.
Diminished functional capacity for other reasons such as: obstructive pulmonary disease (COPD) with forced expiratory volume (FEV) <1 L/min, moderate to severe claudication or morbid obesity
Clinical significant anaemia (haemoglobin < 6 mmol/L), leukopenia (leucocytes < 2 109/L), leucocytosis (leucocytes > 14 109/L) or thrombocytopenia (thrombocytes < 50 109/L)
Reduced kidney function (estimated Glomerular Filtration Rate (eGFR) < 30 ml/min)
Left ventricular thrombus
Anticoagulation treatment that cannot be paused during cell injections. Patients can continue with platelet inhibitor treatment
Patients with reduced immune response or known anti-HLA (human leukocyte antigen) antibodies
History with malignant disease within five years of inclusion or suspected malignity - except treated skin cancer other than melanoma
Pregnant women
Other experimental treatment within four weeks of baseline tests
Participation in another intervention trial
Life expectancy less than one year
Known hypersensitivity to Dimethyl sulfoxide (DMSO), penicillin and streptomycin