A Study of Combined Coronary Artery Bypass Grafting (CABG) and Blood-Borne Autologous Angiogenic Cell Precursors Therapy in Patients With Congestive Heart Failure Due to Ischemic Heart Disease
试验速览
- 阶段
- 1 期
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Evaluation criteria
研究概览
简要总结
Study title: A Study of Combined Coronary Artery Bypass Grafting (CABG) and Blood-Borne Autologous Angiogenic Cell Precursors Therapy in Patients with Congestive Heart Failure due to Ischemic Heart Disease (ACPs-CHF) Principle Investigator: Kit V. Arom ,M.D.,Ph.D. Deputy Director, Chief Cardio-Thoracic Surgeon, Bangkok Heart Hospital Study objective : To determine the safety and efficacy of injection of blood-borne autologous ACPs into the non-graftable area of the heart of patients with congestive heart failure due to ischemic heart disease Its main goal is evaluation of feasibility and safety of the combined technique. The efficacy of the treatment will be tested in the following trial.
Study Design : Phase I , a single center, a non-randomized, open-label trial to test the safety, of intramyocardium transepicardium administration of ex vivo expanded autologous ACPs administered in combination with CABG operation in patients with congestive heart failure due to ischemic heart disease.
The study is a preliminary training study, under the supervision of the experienced Dr. Patel the U.S. principal investigator.
Study population :
Total expected no. of patients : 5 main selection criteria :
- Patients with or without signs of congestive heart failure due to ischemic heart disease who had maximal medical treatments. Not suitable to percutaneous intervention
- All patients must have a recent coronary angiogram. Patients must be able to have OPCAB and then have Angiogenic Cell Precursors(ACPs) in non-graftable and/or infraction regions
- Age 18 to 80 years
- MRI demonstrating areas of viable and non-viable myocardium Investigational Product : The patients will be blood drawn 250 ml at D-8 for producting autologous ACPs (VescellTM), On D0 ,at least 1.5 million ACPs with viability >75 % supended in 15 ml sterile cell culture medium will be injected 1 cm apart using a 23 gauge angled needle in 30 spots (0.5 ml /point) to the same patients by direct intramuscular approach at LV during CABG.
The study consists of 4 periods: Screening ( D-14 to-9& D-8,Treatment(D0),Acute Safety follow-up (D1-2& D5-discharge),Chronic follow-up (D30 & D90)period ,total follow-up of each case is 3 months.
Evaluation criteria :
Safety : no.& duration of adverse event & serious adverse event Efficacy :NYHA, 6-minute walking test ,% LVEF by Echocardiography & C-MRI, % infracted scar area on C-MRI , Pro-BNP & 3 months of QoL(SF-36)
详细描述
Five CAD patients who required CABG with or without congestive heart failure will undergo screening and receiving of ACPs 's injection by direct intramuscular during CABG operation. After that,the patients will come to follow up with investigator at 1 and 3 months post surgery in order to evaluate safety and efficacy of stem cells therapy(ACPs).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with or without signs of congestive heart failure due to ischemic heart disease who had maximal medical treatments. Not suitable to percutaneous intervention
- •All patients must have a recent coronary angiogram. Patients must be able to have OPCAB and then have Angiogenic Cell Precursors(ACPs) in non-graftable and/or infraction regions
- •Age 18 to 80 years
- •Male or non-pregnant, non-lactating female
- •MRI demonstrating areas of viable and non-viable myocardium
- •Informed consent obtained and consent form signed
排除标准
- •Prior Cardiac Surgery or Heart Transplantation
- •Patient who received blood transfusions during the previous 4 weeks (to exclude the potential of non-autologous ACPs in the harvested blood).
- •Inability to communicate (that may interfere with the clinical evaluation of the patient)
- •Acute Myocardial infarction < 6 days from acute event
- •Significant valvular disease or after valve replacement
- •Left Ventricular Aneurysm
- •Collagen tissue disease
- •History of Prior Radiation Exposure
- •History of alcohol or drug abuse within 3 months of screening
- •Renal failure (creatinine > 2 mg/dl) or Hemodialysis
- •Hepatic failure or History of Liver Cirrhosis
- •Females who are capable of reproduction and will not take acceptable measures to prevent reproduction during the study.
- •Anemia (lower than 11mg/dl.hemoglobin for female and lower than 12 mg/dl for male)
- •Abnormal coagulation tests normal [platelets, PT (INR), PTT]
- •Stroke within the preceding 3 years
- •Malignancy within the preceding 3 years
- •Concurrent chronic or acute infectious disease
- •Severe concurrent medical disease (e.g., septicemia, HIV-1,2/HBV/HCV infections, insulin-dependent diabetes mellitus, systemic lupus erythematosus, multiple sclerosis, amyotrophic lateral sclerosis)
- •Chronic immunomodulating or cytotoxic drugs treatment
- •Patients who have rectal temp. above 38.40C for 2 consecutive days
- •Patient unlikely to be available for follow-up
结局指标
主要结局
Evaluation criteria
时间窗: 3 months
Safety : no.& duration of adverse event & serious adverse event
时间窗: 3 months
Efficacy : EF , NYHA
时间窗: 3 months
change from baseline to 1 & 3 months of NYHA, 6-minute walking test
时间窗: 3 months
Change from baseline to 3 months of QoL(SF-36)
时间窗: 3 months
次要结局
- Efficacy:%EF,NYHA(3 months)
- change from baseline to 3 months of % LVEF by Echocardiography & C-MRI(3 months)
- change from baseline to 3 months of % infracted scar area on C-MRI(3 months)
- change from baseline to 3 months of QoL(SF-36)(3 months)