NCT01061580终止1 期
Dose Response Study of Autologous Concentrated Bone Marrow Nucleated Cell Therapy for Congestive Heart Failure Patients Undergoing Treatment With Coronary Artery Bypass Grafting (CABG) Surgery
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Changes in left ventricular function
研究概览
简要总结
Injection of concentrated bone marrow cells into the myocardium during CABG procedure.
详细描述
Injection of autologous concentrated bone marrow cells into the myocardium during CABG procedure.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must meet all of the following inclusion criteria to be enrolled in the trial:
- •Age 18 years and ability to understand the planned treatment.
- •Patients with ischemic congestive heart failure requiring by pass surgery
- •Congestive heart failure with ejection fraction 40%.
- •Serum bilirubin, SGOT and SGPT 2.5 time the upper level of normal.
- •Serum creatinine < 3.0 or no dialysis.
- •NYHA performance status >
- •Negative pregnancy test (in women with childbearing potential).
- •Subject has read and signed the IRB approved Informed Consent form
- •Hematocrit ≥ 28.0%, White Blood Cell count ≤ 14,000, Platelet count ≥ 50,000, Creatinine ≤ 3.0 mg / Dl, and/or no dialysis, INR ≤ 1.6 unless on Coumadin, or PTT <1.5 x control (to avoid bleeding complications) Patients on Coumadin will be corrected prior to the procedure and must have an INR<1.6 at the time of randomization/surgery
排除标准
- •Subjects will be excluded if they meet any of the exclusion criteria:
- •Female who is pregnant or nursing, or of child bearing potential and is not using a reliable birth control method, or who intend to become pregnant during the tenure of this study.
- •History of Prior Radiation Exposure for oncological treatment.
- •History of Bone Marrow Disorder (especially NHL, MDS) that prohibit transplantation.
- •History of abnormal Bleeding or Clotting.
- •History of Liver Cirrhosis.
- •Acute Myocardial Infarction < 4 weeks from treatment date.
- •Known active malignancy or results outside of normal limits from the following tests: PAP, Chest X-ray, PSA, Mammogram, Hemocult unless follow-up studies reveal patient to be cancer free.
- •Active clinical infection being treated by antibiotics within one week of enrollment
- •Terminal renal failure with existing dependence on dialysis
- •Inability or unwillingness to comply with the treatment protocol, follow-up, research tests, or give consent.
- •Unable to have 250cc bone marrow harvested.
- •Medical risk that precludes anesthesia or ASA Class 5
- •History of ventricular arrhythmia if AICD is not present.
- •History of ventricular aneurysm.
- •Concurrent surgery such as CABG with valve surgery.
- •Minimally Invasive bypass surgery
- •Life expectancy <6 months due to concomitant illnesses
- •Treatment with immunosuppressant drugs (including Prednisone > 5 mg per day)
- •Patients undergoing urgent by pass surgical procedure
- •Patients with HGB A1C > 8.5%
结局指标
主要结局
Changes in left ventricular function
时间窗: 12 months
次要结局
- QOL (Rand 36; Minnesota Living with Heart Failure Questionnaire)(12 months)
- NYHA or CCS classification evaluation(12 months)
- Changes in left ventricular ejection fraction(12 months)
- Changes in left ventricular end-diastolic volume(12 months)
- Safety(12 months)
研究者
研究点 (2)
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