2024-517031-51-00撤回2 期
A Phase I-IIa Trial on the Safety and Preliminary Effectiveness of Intramyocardial Injection of Cardiac Atrial Stem Cells for the Treatment of Advanced Ischemic Heart Failure in Subjects with Ischemic Left Ventricular Dysfunction and Chronic Myocardial Infarction.
CASC82 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年8月27日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- MACE : • Death and cause of death
研究概览
简要总结
To evaluate the safety of per operative direct intramyocardial injection of allogeneic cardiac atrial appendage stem cells by determining Major Adverse Cardiac Events (MACE): • Death and cause of death • Re-admissions and cause of re-admission • Myocardial infarction • Tumour formation
研究设计
- 分配方式
- Randomized
- 主要目的
- Randomization
- 盲法
- Double (Investigator, Subject)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Any subject meeting all of the following inclusion criteria and verified by the Investigator during the screening period, i.e. at visits 1 and 2, will be considered acceptable for trial inclusion.
- •Safety laboratory test results and pre-surgery serology are clinically acceptable to undergo surgery at Visits 1 and
- •Women of childbearing potential (WOCBP) including peri-menopausal women who have had a menstrual period within 1 year have to have a negative pregnancy test. Results must be available and negative for the subject to be entered in the trial.
- •WOCBP have to use an effective method of birth control 2 months prior to trial entry or to surgical intervention date and throughout the trial duration (defined as a method which results in a failure rate of less than 1% per year).
- •Subject has understood and accepted to participate in the trial according to all trial procedures by signing the approved informed consent.
- •Male or female subjects aged >18
- •Presence of a documented myocardial infarction due to coronary artery atherosclerotic disease as evidenced by conventional ECG criteria
- •An area of regional dysfunction, i.e. hypokinetic, akinetic or dyskinetic as assessed by echocardiography, ventriculography or MRI-scan.
- •The evidence of scar tissue on MRI-scan as shown by (gadolinium) delayed enhancement.
- •Left ventricular ejection fraction of ≥ 25% and ≤ 45% as determined by clinically indicated assessment of cardiac function (echocardiogram, X-ray, ventriculography, CT and/or MRI).
- •Need for revascularization including the infarcted area by CABG. If no further revascularization is clinically indicated at the time the patient is assessed for participation in the clinical trial this will be determined by a cardiologist who is not an investigator. No further revascularization may be indicated by no arteries with significant stenosis, adequate result of prior PCI, location and extent of any stenosis not suitable for angioplasty.
- •Ability to provide informed consent and follow-up with protocol procedures. Subject is, in the Investigator’s opinion, psychosocially, mentally and physically able to fully comply with this protocol, including the postoperative regimen and follow-up visits.
排除标准
- •Non-cardiovascular disease with life expectancy of less than 1 year
- •NYHA class IV congestive heart failure.
- •Evidence of tumour on screening chest/abdominal/pelvic examination.
- •Subject is on a transplant list or having received a solid organ transplant at any point in the past.
- •Pregnant or breast-feeding woman.
- •Involved in or planning to engage in litigation related health problems.
- •Subject is a prisoner (incarcerated).
- •Subject previously received a cellular therapy (at any point in time).
- •Subject was exposed to therapy for a malignancy or pre-malignant entity, and not confirmed disease-free for 5 years or more.
- •Any clinically relevant chronic disease associated with renal or hepatic insufficiency or any chronic disease of such severity that surgery could be detrimental to the survival of the subject.
- •Any other illness which might reduce life expectancy to less than 2 years from screening.
- •Contra indications to MRI, including prior (MRI non-compatible) ICD placement, estimated glomerular filtration rate less than 50 ml per minute, known reaction to gadolinium, claustrophobia, MRI non-compatible pacemaker and cochlear implant. History of possible presence of ferromagnetic material including programmable shunt, penile prosthesis, intrauterine device, bullets, tattoos, artificial limb, blood vessel coil and tissue expander may require special screening.
- •Subject is on chronic immunosuppressive therapy (immunosuppressants or immunotherapy) due to inflammatory or systemic disease.
- •Subject has a history of any autoimmune disease such as systemic lupus erythematosus, Addison's disease, active Crohn's disease, or rheumatoid arthritis.
- •History of cardiac tumour or cardiac tumour demonstrated on MRI.
- •Patients in whom revascularisation of the infarct-related artery is technically not possible
- •Current alcohol or drug abuse because of anticipated difficulty in complying with protocol related procedures.
- •Abnormal liver function (GPT > 3 times the upper reference range) and/or haematology (hematocrit < 25%, WBC < 3000, platelets < 100000) studies without a reversible, identifiable cause.
- •Subject has compromised renal function as reflected by a serum creatinine level >3.0 mg/dL (>0.265 mmol/l) or is currently on dialysis.
- •Ventricular tachycardia or fibrillation not associated with an acute ischemic episode.
- •Symptomatic ventricular tachyarrhythmia complicating the index infarction.
结局指标
主要结局
MACE : • Death and cause of death
MACE : • Death and cause of death
MACE : • Re-admissions and cause of re-admission
MACE : • Re-admissions and cause of re-admission
MACE : • Myocardial infarction
MACE : • Myocardial infarction
MACE : • Tumour formation
MACE : • Tumour formation
次要结局
- safety - non-MACE : • worsening of heart failure events defined as requiring unscheduled treatment for signs and symptoms of heart failure in an urgent outpatient setting or requiring hospital admission
- safety - non - MACE: • aborted sudden death events, defined as resuscitated sudden death or appropriate Automatic Implantable Cardioverter Defibrillator (AICD) therapy for severe ventricular tachyarrhythmias
- safety - non-MACE : • change in Six-Minute Walk Test from pre-procedure
- safety - non-safety : • total days alive out of hospital
- safety - non - MACE : • changes in NYHA class from pre-procedure and proportion of patients with improved NYHA classification
- efficacy : • global and regional left ventricular function
- efficacy : • ventricular dimensions
- efficacy : • measurements of infarct size
研究者
Clinical Trial Information Desk
Scientific
CASC8
研究点 (2)
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