NL-OMON47824RecruitingPhase 3
Stem Cell therapy in IschEmic Non-treatable Cardiac disease - SCIENCE - SCIENCE
Rigshospitalet Copenhagen University Hospital, Capital Region of Denmark0 sites20 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Enrollment
- 20
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
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
Investigators
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