NCT02041000撤回不适用
An Open-label, Non-Randomized, Multi-Center Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Cells Delivered Intravenously in Patients With Chronic Obstructive Pulmonary Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Safety
研究概览
简要总结
The intent of this clinical study is to answer the questions: 1) Is the proposed treatment safe and 2) Is treatment effective in improving the disease pathology of patients with diagnosed with chronic obstructive pulmonary disease (COPD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A prior diagnosis of moderate or severe COPD
- •GOLD III and IV
- •Age between 18 and 85 years
排除标准
- •Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study
- •Life expectancy < 6 months due to concomitant illnesses.
- •Exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study.
- •Active infectious disease patients known to have tested positive for HIV, HTLV, HBV, HCV, CMV (IgM > IgG) and/or syphilis. will have an expert consulted as to patient eligibility based on the patient's infectious status
- •Any illness which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results
- •Patients on chronic immunosuppressive transplant therapy
- •Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate.
- •Severe asthma that would contraindicate surgery
- •History of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years.
- •Patients with Alpha-1
- •Unwilling and/or not able to give written informed consent.
结局指标
主要结局
Safety
时间窗: 6 months
Safety will be assessed as the occurrence/frequency (if applicable) of adverse events during the study procedures and for up to 6 months afterward.
St. George Respiratory
时间窗: 6 months
The St. George Respiratory questionnaire is an index developed to identify the quality of life of patients by measuring and quantifying health-related health status of patients with airflow obstruction.
次要结局
- Gold Classification(6 months)
- 6 Minute Walk Test(6 months)
研究者
研究点 (1)
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