EUCTR2013-001358-81-ES进行中（未招募）1 期
First-in-human clinical trial, double blind, randomized with placebo, open for the six first patients (dose ranging), to evaluate the safety and efficacy of intracoronary infusion of allogeneic human cardiac stem cells (CSCs) in patients with Acute Myocardial Infarction and Left Ventricular Dysfunction. - CAREMI - CAREMI
Coretherapix S.L.U.0 个研究点目标入组 55 人开始时间: 2014年2月18日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 55
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. Adult patients ? 18 years of age and ? 80 years.
- •2. Patients presenting a ST-segment-elevation in the acute myocardial infarction (STEMI) according to the universally accepted definition founded in the STEMI management guide of the European Society of Cardiology
- •3. Killip ? 2 on admission
- •4. Successful primary percutaneous coronary intervention (PCI) (Thrombolysis In Myocardial Infarction [TIMI] = 3) during the first 12h after infarct symptoms
- •5. Bare-metal stent at primary PCI
- •6. Ejection Fraction (EF) ?45% analyzed by echocardiography at day 2 after primary PCI
- •7. Ejection Fraction (EF) ?45% analyzed by magnetic resonance imaging (MRI). This MRI will be done between day 3 and day 7 after infarction.
- •8. Patients with an infarct size in left ventricle (LV) ?25% tested in the first MRI will be included.
- •9. The affected coronary artery must be adequate for cells infusion by catheterization.
- •10. The presence of microvascular obstruction at inclusion MRI is permitted
- •11. The patient is stable and in adequate clinical condition to undergo the administration of the cell medicine through a second catheterization, between 4-7 days after the first PCI.
- •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 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •1. Participation in another clinical trial in the last 30 days
- •2. Has previously received cell or gene therapy
- •3. Women who are pregnant or breastfeeding
- •4. Mental disease or psychological condition that impedes the subject from understanding the nature of the protocol and granting his/her consent
- •5. Previous Q-wave infarction
- •6. Valve disease, relapsing pericarditis, history of cardiac tamponade, cardiomyopathies
- •7. Involvement of coronary trunk
- •8. Severe stenotic lesion (>90%) in a coronary vessel with size >2.75mm, shown in the first PCI and non revascularizable during primary PCI
- •9. Admission for prior HF or EF<45 or NYHA > 2 before STEMI
- •10. Killip >2 on admission
- •11. History of sustained VT or VF at any point since hospital admission
- •12. Sustained VT that does not revert with treatment or requires >6 hours to be controlled in the 48 hours prior to the product administration procedure
- •13. Complete Auriculo Ventricular blockade on arrival to the Emergency Room (previously unknown), or acute branch block during hospitalization
- •14. History of cardioembolic disease
- •15. Platelets <100,000 and/or Hb<8.5g/dL
- •16. Acute or chronic renal failure with creatinine ?2.5 or creatinine clearance ?50 mL/min
- •17. Infection with systemic involvement (fever or documented Systemic Inflammatory Response Syndrome) current and/or in the month prior to AMI
- •18. History of bleeding in the 3 months prior to screening in any location due to uncontrolled coagulopathy
- •19. Cancer disease, except that eradicated at least 5 years before inclusion, and without receiving radiotherapy on chest. It is permitted coetaneous non-melanoma neoplasms completely eliminated (at any time) and that do not require subsequent chemotherapy or radiotherapy on chest.
- •20. Child's C stage chronic liver disease
- •21. Stroke in the previous 12 months
- •22. Baseline respiratory failure and/or requires oxygen at home
- •23. Advanced dementia according to the Barthel index
- •24. History of autoimmune disease and/or positive autoantibodies at least double titer of the normal ranges
- •25. Patients with Hepatitis B virus (HBV), Hepatitis C virus (HCV), Human Immunodeficiency virus (HIV) or asymptomatic carriers (positive without clinical disease) except positive for HBV by vaccination
- •26. Uncontrolled hypertension at screening despite treatment (systolic blood pressure [BP] ? 180 and/or diastolic BP ? 110)
- •27. Very poorly controlled diabetes (Hb1Ac ?8.5 g/dL) or with serious target organ lesion (peripheral vascular disease requiring revascularization or non revascularizable, CRF with creatinine clearance ?50 mL/min, stroke in the previous 12 months, severe non-revascularizable coronary disease)
- •28. Primary or acquired immune deficiency or immunosuppressant treatment (including treatments with immunosuppressants in the previous three months or with systemic corticosteroids in the previous month or foreseeable need for those treatments during the course of the study).
- •29. Very poorly controlled hypercholesterolemia (total cholesterol ?250 mg/dL despite treatment)
- •30. Active smoking greater than or equal to 40 cigarettes/day
- •31. Recreational drug use that would hamper heart or cardiovascular function, at least once in the past 6 months
- •32. Weekly alcohol consumption over 80 g per kg
- •33. Women of childbearing potential who do not agree to use contraceptives during the study period and up to 6 months afterwards
- •34. Life expectancy of less than 2 years for any reason.
研究者
相似试验
进行中（未招募）
1 期
First-in-human clinical trial using human cardiac stem cells obtained from a donor for Acute Myocardial Infarction treatment. Patients will receive either cells or placebo by intracoronary infusion to evaluate the safety and efficacy of this treatment.Acute Myocardial Infarction (AMI):First STEMI submitted to elective primary PCI with successful revascularization by PCI (TIMI = 3), but intermediate-high risk of HF development (infarct size by MRI>25%)EUCTR2013-001358-81-BECoretherapix S.L.U.55
已完成
不适用
A First-in-Human study in healthy male volunteers to investigate the safety, tolerability and pharmacokinetics of recombinant human soluble Fc gamma receptor IIb, sFc?RIIb (SM101) administered intravenously as single ascending dosesISRCTN09512688SuppreMol GmbH (Germany)42
进行中（未招募）
1 期
CLINICAL TRIAL TO EVALUATE THE EFFICACY OF IBUPROFEN COMBINED WITH DIFFERENT DOSES OF TRAMADOL AND TRAMADOL INTRAVENOUS AFTER DENTAL SURGERYModerate-Intense pain in Dental SurgeryMedDRA version: 20.0 Level: HLT Classification code 10044049 Term: Dental pain and sensation disorders System Organ Class: 100000004856EUCTR2018-001412-30-ESaboratorios Farmalíder S.A.112
招募中
2 期
Effects of Vitamin E Delta-tocotrienol supplementation in Nonalcoholic Fatty Liver Disease (NAFLD)onalcoholic fatty liver disease (NAFLD)SLCTR/2015/023Armed Forces Institute of Pathology, Pakistan
进行中（未招募）
1 期
First in human study of Apta-1ISRCTN15455814Aptahem AB72