Evaluation of Safety and Efficacy of Autologous Adipose Derived Stem Cells Transplantation for Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 20
- 试验地点
- 5
- 主要终点
- SGOT
研究概览
简要总结
Chronic obstructive pulmonary disease (COPD) is the name for a collection of lung diseases including chronic bronchitis, emphysema and chronic obstructive airways disease. People with COPD have difficulties breathing, primarily due to the narrowing of their airways, this is called airflow obstruction.
Some preclinical evaluations showed that COPD is closely related to chronic inflammation; therefore, this study aimed to use adipose-derived stem cells (ADSCs) in the form of non-expanded culture - that usually names as a stromal vascular fraction (SVF) in combination with activated platelet rich plasma (PRP) to treat this disease. Both SVF and PRP are autologous sources that obtained from adipose tissue and peripheral blood, respectively. This mixture is intravenously transfused into the patients.
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40 to 80, inclusive
- •A prior diagnosis of moderate to severe COPD
- •GOLD IIa, III, IV
排除标准
- •Pregnant or lactating
- •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.
- •Any illness which, in the Investigators judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of study results
- •Subjects on chronic immunosuppressive or chemotherapeutic 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.
- •Subjects with Alpha-1 antitrypsin deficiency (an inherited disorder that can cause lung disease and liver disease).
- •Unwilling and/or not able to give written consent
- •Patient is positive for hepatitis (past history of Hepatitis A is allowed)
- •Any medical condition, which in the opinion of the clinical investigator, would interfere with the treatment or outcome of the patient
- •Cerebral aneurysm clips
结局指标
主要结局
SGOT
时间窗: 1 month
The blood SGOT levels are thus elevated with liver damage
SGPT
时间窗: 1 month
The blood SGPT levels are thus elevated with liver damage
次要结局
- 6 min walk test(1 month, 6 months, 12 months)
- CRP concentration(6 months, 12 months)
- rates of panic attacks(1 month, 6 months, 12 months)
- Respiration rate(1 month, 6 months, 12 months)
研究者
Phuc Van Pham
MSc, PhD.
University of Science Ho Chi Minh City