EUCTR2018-002538-19-SI进行中（未招募）1 期
Stem Cell therapy in non-IschEmic Non-treatable dilated CardiomyopathiEsII: a pilot study - SCIENCE II - Pilot
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. 30 to 80 years of age
- •2. Signed informed consent
- •3. Patients with non-ischemic dilated cardiomyopathy
- •4. NYHA = II in spite of optimal heart failure treatment and have no other treatment options
- •5. Heart failure medication unchanged two months prior to inclusion/signature of informed consent. Changes in diuretics accepted
- •6. LVEF = 405%
- •7. Plasma NT-pro-BNP > 300 pg/ml (> 35 pmol/L)
- •8. Patients cannot be included until three months after implantation of a cardiac resynchronisation therapy device (CRTD) and until 1 month after an ICD unit
- •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 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •1. Heart Failure NYHA I
- •2. Moderate to severe aortic stenosis (valve area < 1.3 cm2) or valvular disease with option for surgery or interventional therapy.
- •3. Heart failure caused by cardiac valve disease or untreated hypertension.
- •4. If the patient is expected to be candidate for MitraClip therapy of mitral regurgitation in the 12 months follow-up period.
- •5. 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
- •6. Cardiomyopathy in association with a neuromuscular disorder e.g. Duchenne's progressive muscular dystrophy
- •7. Previous cardiac surgery
- •8. Diminished functional capacity for other reasons such as: obstructive pulmonary disease (COPD) with forced expiratory volume (FEV) < 1L/min, moderate to severe claudication or mobid 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.
- •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. Woman of childbearing potential unless ßHCG negative and they should be on contraception during the trial
- •17. Other experimental treatment within four weeks of baseline tests
- •18. Participation in another intervention trial
- •19. Life expectancy less than one year
研究者
相似试验
进行中（未招募）
1 期
Stem cell therapy in heart failureIschemic heart disease and heart failureMedDRA version: 19.0Level: LLTClassification code 10019279Term: Heart failureSystem Organ Class: 100000004849EUCTR2015-002929-19-DEDepartment of Cardiology, Rigshospitalet139
进行中（未招募）
1 期
Stem cell therapy in heart failureIschemic heart disease and heart failureMedDRA version: 19.0Level: LLTClassification code 10019279Term: Heart failureSystem Organ Class: 100000004849EUCTR2015-002929-19-DKDepartment of Cardiology, Rigshospitalet138
进行中（未招募）
1 期
Stem cell therapy in heart failureIschemic heart disease and heart failureMedDRA version: 20.0Level: LLTClassification code 10019279Term: Heart failureSystem Organ Class: 100000011680EUCTR2015-002929-19-PLDepartment of Cardiology, Rigshospitalet139
进行中（未招募）
1 期
Stem cell therapy in heart failureIschemic heart disease and heart failureMedDRA version: 18.1Level: LLTClassification code 10019279Term: Heart failureSystem Organ Class: 100000004849EUCTR2015-002929-19-NLDepartment of Cardiology, Rigshospitalet139
招募中
3 期
Stem Cell therapy in IschEmic Non-treatable Cardiac disease - SCIENCEischaemic heart failure10019280NL-OMON47824Rigshospitalet Copenhagen University Hospital, Capital Region of Denmark20