NCT01074099终止1 期
Feasibility 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
- 5
- 试验地点
- 4
- 主要终点
- Change in Cardiac Status (Classification)
研究概览
简要总结
Patients undergoing CABG will have 60 mL of bone marrow drawn, concentrated in a SmartPRep2 centrifuge and have the concentrated nucleated cells injected into areas of ischemic myocardium
详细描述
Patients undergoing CABG will have 60 mL of bone marrow drawn, concentrated in a SmartPRep2 centrifuge and have the concentrated nucleated cells injected into areas of ischemic myocardium. Control subjects will undergo CABG only
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •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
- •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, Hemoccult 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
Change in Cardiac Status (Classification)
时间窗: Through 12 months post treatment
A change in cardiac status as determined by the New York Heart Association (NYHA) or Canadian Cardiovascular Society (CCS) classification evaluation
Safety
时间窗: through 1 Year post tx
as measured by frequency and severity of adverse events
次要结局
未报告次要终点
研究者
研究点 (4)
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