Heart Failure Clinical Trial
— SCIENCEOfficial title:
Stem Cell Therapy in IschEmic Non-treatable Cardiac Disease - SCIENCE A European Multi-Centre Trial
NCT number | NCT02673164 |
Other study ID # | SCIENCE |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | January 2017 |
Est. completion date | December 2020 |
Verified date | January 2021 |
Source | Rigshospitalet, Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 133 |
Est. completion date | December 2020 |
Est. primary completion date | December 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years to 80 Years |
Eligibility | Inclusion Criteria: 1. 30 to 80 years of age 2. Signed informed consent 3. Chronic stable ischemic heart disease 4. Symptomatic heart failure New York Heart Association (NYHA) class II-III 5. EF = 45% on echocardiography, Computerized Tomography (CT) or Magnetic Resonances Imaging (MRI) scan 6. Plasma NT-pro-BNP > 300 pg/ml (> 35 pmol/L) 7. Maximal tolerable heart failure medication 8. Heart failure medication unchanged two months prior to inclusion. Changes in diuretics accepted. 9. No option for percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) 10. 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 11. 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: 1. Heart Failure (NYHA class I or IV) 2. 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. 3. Other revascularisation treatment within four months of treatment 4. If clinically indicated the patient should have a coronary angiography before inclusion 5. Moderate to severe aortic stenosis (valve area < 1.3 cm2) or valvular disease with option for surgery or interventional therapy. 6. Aortic valve replacement with an artificial heart valve. However, a trans-septal treatment approach can be considered in these patients. 7. If the patient is expected to be candidate for MitraClip therapy of mitral regurgitation in the 12 months follow-up period. 8. 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 9. Clinical significant anaemia (haemoglobin < 6 mmol/L), leukopenia (leucocytes < 2 109/L), leucocytosis (leucocytes > 14 109/L) or thrombocytopenia (thrombocytes < 50 109/L) 10. Reduced kidney function (estimated Glomerular Filtration Rate (eGFR) < 30 ml/min) 11. Left ventricular thrombus 12. Anticoagulation treatment that cannot be paused during cell injections. Patients can continue with platelet inhibitor treatment 13. Patients with reduced immune response or known anti-HLA (human leukocyte antigen) antibodies 14. History with malignant disease within five years of inclusion or suspected malignity - except treated skin cancer other than melanoma 15. Pregnant women 16. Other experimental treatment within four weeks of baseline tests 17. Participation in another intervention trial 18. Life expectancy less than one year 19. Known hypersensitivity to Dimethyl sulfoxide (DMSO), penicillin and streptomycin |
Country | Name | City | State |
---|---|---|---|
Denmark | 2014 Department of Cardiology, The Heart Centre, University Hospital Rigshospitalet | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
JKastrup | European Union |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | left ventricle end-systolic volume (LVESV) | The primary endpoint is change in left ventricle end-systolic volume (LVESV) from baseline to 6 months follow-up measured by ECHO, MR and CT between CSCC_ASC and placebo treated | 6 months | |
Secondary | Safety - Serious adverse events | Incidence and severity of serious adverse events and suspected unrelated serious adverse events 12 months follow-up | 6 months |
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