Stem cell therapy in heart failure

Active, not recruiting

Conditions: Ischemic heart disease and heart failure
MedDRA version: 18.0Level: LLTClassification code 10019279Term: Heart failureSystem Organ Class: 100000004849
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2015-001560-19-DK

Lead Sponsor: Department of Cardiology, Rigshospitalet

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1.30 to 80 years of age
2.Signed informed consent
3.Chronic stable ischemic heart disease
4.Heart failure (NYHA II-III)
5.LVEF =45%
6.Plasma NT-pro-BNP > 300 pg/ml (> 35 pmol/L) in sinus rhythm and plasma NT-pro-BNP > 422 pg/ml (> 450 pmol/L) in patients with atrial fibrillation
7.Maximal tolerable heart failure medication
8.Medication unchanged two months prior to inclusion
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 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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 61

Exclusion Criteria

Exclusion criteria
1.Heart Failure (NYHA I or IV)
2.Acute coronary syndrome with elevation of CKMB or troponins, stroke or transitory cerebral ischemia within six weeks of inclusion
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 mm2) or valvular disease with option for surgery.
6.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
7.Clinical significant anaemia (haemoglobin < 6 mmol/L), leukopenia (leucocytes < 2 109/L), leucocytosis (leucocytes >14 109/L) or thrombocytopenia (thrombocytes < 50 109/L)
8.Anticoagulation treatment that cannot be paused during cell injections
9.Patients with reduced immune response
10.History with malignant disease within five years of inclusion or suspected malignity – except treated skin cancer other than melanoma
11.Pregnant women
12.Other experimental treatment within four weeks of baseline tests
13.Participation in another intervention trial

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To perform at clinical double-blind placebo-controlled CSCC_ASC multicentre study in heart failure patients to investigate the regenerative capacity of the CSCC_ASC treatment.;Secondary Objective: Improvement in cardiac function and clinical symptoms;Primary end point(s): The primary endpoint is change in left ventricle end-systolic volume (LVESV) at 6 months follow-up between CSCC_ASC and placebo patients.;Timepoint(s) of evaluation of this end point: 6 months after treatment

Secondary Outcome Measures