Use of Autologous, Adult Adipose-Derived Stem/Stromal Cells (AD-cSVF) in Chronic Lung Disorders
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Safety - Pulmonary Function
研究概览
简要总结
Chronic Obstructive Pulmonary Disease (COPD) is a lung-related disorder that is characterized by long-term, often progressive state of poor airflow. Primary symptoms include low oxygen tension, shortness of breath, productive cough, and broncho-pulmonary inflammation and interference with oxygen-carbon dioxide exchange.
Air pollution and tobacco smoking are felt to be the most common cause of these issues. Diagnostic testing is based on poor airflow measured by lung function studies and whose symptoms do not improve much with antiasthma bronchodilators.
Study is an interventional study to document the safety and efficacy of use of AD-cSVF in chronic broncho-pulmonary disease groups.
详细描述
COPD is often treated by limiting exposure to poor air quality, but there is no cure at this time. Attempted therapy include smoking cessation, vaccinations, respiratory rehabilitation, and attempts of use of bronchodilators and steroids. Many resort to supplemental oxygen therapy, lung transplantation, and antibiotic supportive therapy during exacerbations.
As of 2013, COPD involve approximately 5% pf the global populations (approximately 330 million). Most commonly it occurs approximately equally between men/women and result in about 3 million deaths per year. Estimates of economic costs are estimated to be more than 2.1 trillion dollars in 2010.
This study includes microcannula harvesting of subdermal adipose tissues, incubation, digestion and isolation of AD-cSVF. This stromal cellular pellet (without actual extracellular matrix or stromal elements) is then suspended in 500 cc sterile Normal Saline (NS) and deployed via peripheral intravenous route. Evaluations of safety issues are measured at intervals (both severe and non-severe categories) and by repeated pulmonary function studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Prior Diagnosis of moderate to severe COPD
- •GOLD II a, III, IV
排除标准
- •Pregnant or Lactating Females
- •Life expectancy of < 3 months due to concomitant illnesses
- •Exposure to any investigational drug or procedure with 1 month prior to study entry or enrollment in concurrent study which may interfere with interpretation of study results
- •Illness which, in investigators judgement, may interfere with the patient' ability to comply with protocol, compromise patient safety, ability to provide informed consent to study, or interfere with interpretation of study outcomes
- •Subjects on chronic immunosuppressive or chemotherapeutic medications
- •Known drug or alcohol dependence or other factors which may interfere with study conduct or interpretation of result or in the opinion of investigator are not suitable to participate.
- •Subjects with documented Alpha-1 Antitrypsin Deficiency (Inherited lung and liver disorder)
- •Unwilling or not competent to understand and execute an informed consent agreement
- •Patients positive for Hepatitis (Hepatitis A history excepted)
研究组 & 干预措施
Lipoaspiration Arm 1
Acquisition of Adipose-Derived tissue Stromal Vascular Fraction (AD-tSVF) via closed syringe harvest subdermal fat
干预措施: lipoaspiration (Procedure)
AD-cSVF Arm 2
Isolation of cellular stem/stromal cells from subdermal adipose-derived cellular stromal vascular fraction (AD-cSVF)
干预措施: ADcSVF (Procedure)
Normal Saline IV Arm 3
Normal Saline IV with AD-cSVF cells
干预措施: Normal Saline IV (Procedure)
结局指标
主要结局
Safety - Pulmonary Function
时间窗: 12 months Evaluate Function and Adverse Events
Pulmonary Function to be Addressed as occurrence or frequency of adverse event during study
次要结局
- Change from baseline 6 Minute Walk Test(12 Months)
- Change from Baseline Lung X-Ray(6 months, 12 months)
- Change from Baseline SGOT Blood Testing(1 Month)
- Change from Baseline SGPT Blood Testing(1 Month)
- GOLD Classification(1 year)
- Change from Baseline Respiratory Rate(1 month, 6 month, 1 year)
- Pulmonary Function Testing(Baseline, 6 Months)
研究者
Robert W. Alexander, MD, FICS
Principal Investigator, Science
Healeon Medical Inc