Stem Cell Therapy in Non-IschEmic Non-treatable Dilated CardiomyopathiEs II: a Pilot Study (NCT03797092) | Clinical Trial Compass
UnknownPhase 1/2
Stem Cell Therapy in Non-IschEmic Non-treatable Dilated CardiomyopathiEs II: a Pilot Study
Denmark30 participantsStarted 2019-10-01
Plain-language summary
The overall aim of the project is to test the feasibility and safety of allogeneic adipose-derived stromal cells (CSCC\_ASC) investigational medicinal product, to improve myocardial function in patients with non-ischemic dilated cardiomyopathies (NIDCM) and heart failure.
Who can participate
Age range30 Years – 80 Years
SexALL
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Inclusion criteria
✓. 30 to 80 years of age
✓. Signed informed consent
✓. Patients with non-ischemic dilated cardiomyopathy
✓. NYHA ≥ II in spite of optimal heart failure treatment and have no other treatment options
✓. Heart failure medication unchanged two months prior to inclusion/signature of informed consent. Changes in diuretics accepted
✓. LVEF ≤ 405%
✓. Plasma NT-pro-BNP \> 300 pg/ml (\> 35 pmol/L)
✓. 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 I
✕. Moderate to severe aortic stenosis (valve area \< 1.3 cm2) or valvular disease with option for surgery or interventional therapy.
✕. Heart failure caused by cardiac valve disease or untreated hypertension.
✕. If the patient is expected to be candidate for MitraClip therapy of mitral regurgitation in the 12 months follow-up period.
✕. Cardiomyopathy with a reversible cause that has not been treated e.g. thyroid disease, alcohol abuse, hypophosphataemia, hypocalcaemia, cocaine abuse, selenium toxicity \& chronic uncontrolled tachycardia
✕. Cardiomyopathy in association with a neuromuscular disorder e.g. Duchenne's progressive muscular dystrophy
✕. Previous cardiac surgery
✕. 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