NCT00300053已完成2 期
A DB, Randomized, Placebo-controlled Study of the Tolerability, Efficacy, Safety, and Dose Range of Intramyocardial CLBS14 for Reduction of Angina Episodes in Patients With Refractory Chronic Myocardial Ischemia (ACT34-CMI)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 321
- 试验地点
- 49
- 主要终点
- Number of Angina Episodes Per Week at 6 and 12 Months
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of intramyocardial injections of CLBS14 in patients with refractory chronic myocardial ischemia.
详细描述
This is a double-blind, prospective, randomized, placebo-controlled trial to determine the tolerability, efficacy, safety and dose range of intramyocardial injections of adult autologous CD34+ cells mobilized with granulocyte colony stimulating factor (G-CSF) for the reduction of angina episodes in patients with refractory chronic myocardial ischemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Canadian Cardiovascular Society (CCS) functional class III or IV chronic refractory angina
- •subjects without control of their angina symptoms, in spite of maximal tolerated doses of anti-anginal drugs, must be on optimal therapy for their angina and on a stable anti-anginal medication regimen for at least 1 month prior to entering the screening period of the study
- •identified as unsuitable for conventional revascularization
- •recent coronary angiogram (within the last 12 months) to document the coronary anatomy and to verify the revascularization procedures
- •subjects must have objective evidence of inducible ischemia or viable myocardium in the potential target injection zone
- •a left ventricular ejection fraction equal to or greater than 25% by ECHO or single photon emission computed tomography (SPECT) at screening
- •subjects must experience at minimum an average of 7 angina or anginal equivalent episodes per week
- •subjects must be able to complete a minimum of 3 minutes but nor more than 10 minutes on a treadmill following the Modified Bruce Protocol
- •subjects must experience angina or anginal equivalent episodes during the screening exercise treadmill test
- •female subjects must either be no longer capable of reproduction or using medically valid contraception to prevent pregnancy during the study
- •subjects must be willing and able to comply with specified follow-up evaluations
排除标准
- •predominant congestive heart failure
- •myocardial infarction within 60 days of treatment
- •successful or partially successful coronary revascularization procedures (any vessel) within 6 months of study enrollment
- •placement of a bi-ventricular pacemaker for cardiac resynchronization therapy (CRT) for heart failure in the past 90 days
- •documented stroke or transient ischemic attack (TIA) within 60 days of study enrollment
- •history of moderate to severe aortic stenosis or severe aortic insufficiency; severe mitral stenosis or severe mitral insufficiency
- •prosthetic aortic valve replacement
- •evidence of any life-threatening arrhythmia that requires intervention on the 24-hour Holter monitor. Life-threatening arrhythmia that is successfully treated with an implantable cardioverter defibrillator (ICD) is not exclusionary.
- •splenomegaly and/or severe co-morbidity associated with a reduction in life expectancy of less than 1 year, such as chronic medical illness (ie, severe chronic obstructive pulmonary disease, renal failure or cancer [exceptions: in-situ skin cancer or fully removed skin cancer other than melanoma, in-situ cervical cancer, or cancer free for 5 years with no history of a stem cell transplant])
- •sickle cell disease or sickle cell trait
- •platelet count greater than 10% above the upper limit of normal or a platelet count below 100,000 if on Clopidogrel or 50,000 without Clopidogrel
- •hematocrit <30%
- •serum creatinine >2.5 mg/dL
- •any clinically significant laboratory abnormality on screening laboratories
- •currently enrolled in another IDE or IND that has not completed the protocol required primary follow-up period (excludes 15 year follow up of gene therapy trials)
- •history of alcohol or drug abuse within 3 months of screening
- •joint or peripheral vascular disease or neurologic disease that severely limits treadmill walking
- •chronic obstructive pulmonary disease that severely limits walking or FEV1 <30% predicted
- •females who are pregnant or lactating
- •female subjects who are capable of reproduction and will not use medically valid contraception to prevent pregnancy during the study
- •subjects who test positive for HIV, hepatitis B or hepatitis C, or are on chronic immunosuppressive medications or have had a prior stem cell transplant
- •subjects with a known hypersensitivity to E. coli-derived proteins, or to any component of Neupogen (Filgrastim) or G-CSF
- •subjects who have a significant psychiatric disorder or mental disability that could interfere with the subject´s ability to provide informed consent and/or comply with protocol procedures
结局指标
主要结局
Number of Angina Episodes Per Week at 6 and 12 Months
时间窗: 6 and 12 months
The number of angina episodes were collected via an electronic subject diary for four weeks at Baseline and at 6 and 12 months. The four-week angina episodes (per week mean) were used as the frequency for each visit. A lower number represents fewer angina episodes. A lower number is better.
次要结局
- Exercise Treadmill Test According to Modified Bruce Protocol: Mean Change From Baseline in Duration of Exercise(Change from Baseline to 6 months and change from baseline to 12 months after treatment)
- Changes From Baseline in Seattle Angina Questionnaire (SAQ) Scores at 6 Months(Baseline to 6 months after treatment)
- Change in Anti-anginal Medication (ie, Nitroglycerin) Use(Baseline to 6 months)
- Number of Participants With Change in Canadian Cardiovascular Society Anginal Classification Levels(Baseline and 12 months after treatment)
- Changes From Baseline to 6 Months in Short Form 36 (SF-36) Parameters(Baseline to 6 months after treatment)
研究者
研究点 (49)
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