Stem Cell therapy in IschEmic Non-treatable Cardiac disease

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

1. 30 to 80 years of age
2. Signed informed consent
3. Chronic stable ischemic heart disease
4. Symptomatic Heart failure (NYHA II-III)
5. LVEF <=45% on echocardiography, CT or MRI scan.
6. Plasma NT-pro-BNP > 300 pg/ml (> 35 pmol/L)
7. Maximal tolerable heart failure medication
8. Medication unchanged two months prior to inclusion/signature of informed
consent. 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 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 1 month after an ICD unit

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. 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 (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
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 DMSO, penicillin and streptomycin

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is change in left ventricle end-systolic volume (LVESV) at<br /><br>6 months follow-up between CSCC_ASC and placebo treated measured by<br /><br>echocardiography.</p><br>

Secondary Outcome Measures