An Open-label, Non-Randomized, Multi-Center Study to Assess the Safety and Effects of Intra-venous and Inhalation Implantation of Autologous Adipose-Derived Stromal Vascular Fraction Cells in Patients With Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Functional Capacity improved compared to baseline
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 health of patients with human Chronic Obstructive Pulmonary Disease.
详细描述
This will be an open-label, non-randomized multi-center patient sponsored study of Autologous SVF (AD-SVF) implantation after liposuction using an IV delivery system and Inhalation infusion. AD-SVF will be derived from the patient's adipose-derived tissue. Liposuction using local anesthesia and syringe collection will be performed to collect the adipose tissue specimen for subsequent processing to isolate the stem cells. The cells will be delivered intravenously.
The adipose tissue specimen will be collected from the patient's abdomen or applicable area using tumescent syringe liposuction. The adipose tissue is transferred to the laboratory for separation of the adipose tissue-derived stem cells, which are then transferred for IV delivery. The number of cells injected will vary depending on the amount of tissue processed and the number of cells obtained from the process.
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 80 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 25 and 80 years
- •Up to date on all age and gender appropriate cancer screening per American Cancer Society
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.
- •Unwilling and/or not able to give written informed consent.
研究组 & 干预措施
Intravenous Injection and Inhalation infusion of AD-SVF
AD-SVF harvested from Autologous Adipose Tissue will be deliver after processing via IV and Inhalation
干预措施: Lipoaspiration with Local anesthesia (Procedure)
结局指标
主要结局
Functional Capacity improved compared to baseline
时间窗: 3 months, 6 months
6 Minute Walk Test
Number of adverse events
时间窗: 3 months, 6 months
次要结局
- Quality of Life improved compared to baseline(3 months, 6 months)