The Effect of Autologous Adipose Mesenchymal Stem Cells in Treatment of Airway Injury in Patients Exposed to Sulfur Mustard
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 10
- 主要终点
- pulmonary function testing (PFT)
研究概览
简要总结
Background: Sulfur mustard (SM) is a potent alkylating agent that targets several organs, especially lung tissue. SM exposure leads to serious changes in morphological structure of airway system, which is associated with chronic obstructive pulmonary deficiency following exposure to SM. With extensive progress and achievements in tissue repair through stem cells therapy, consideration of lung tissue has been increased due to the high prevalence of pulmonary problems. Several factors such as selection of cell types, required conditions for growth and proliferation of stem cells, and the process of entering into the body to repair damaged lung tissue are considered as the most important problems in this issue. Accumulating studies, both in animals and human with mesenchymal stem cells (MSC) support the hypothesis of therapeutic effects of these cells in various disorders. In this study investigators aimed to evaluate safety and potential efficacy of systemic MSC administration for treatment of chronic lung injuries in SM-exposed patients.
Methods: Patients will receive 100 million MSC cells every two months for three injections within 6 months. After each injection, parameters including safety, pulmonary function testing (PFT), quality-of-life indicators, 6 minute walk test (6MWT), and expression of inflammation and oxidative stress genes will be evaluated.
详细描述
Patients selection:
In this clinical trial, investigators considered therapeutic effect of MSCs in SM-exposed male patients.Patients, had a documented encounter with SM during the Iran-Iraq war. The patients signed informed consent before study. They were selected according to the following criteria: (a) the severity of lung injury was ranged from moderate 50< forced expiratory volume in 1 second (FEV1) <65 to severe 40<FEV1<50; (b) absence of contraindications spirometry (hemoptysis, cerebral arterial aneurysm or aortic, pulmonary embolism, uncontrolled blood pressure, recent pneumothorax, no doubt surgery/thoracic recent, recent stroke); and (c) no coagulation. The exclusion criteria for the selection process were as follow: (a) participate in another study at the same time; (b) smoking habitat; (c) the existence of pneumonia during the study; (d) the incidence of transfusion reaction; (e) underlying other diseases (cardiovascular disease, hypertension, diabetes).
Isolation and culture of adipose derived stem cells:
200mL of abdominal adipose tissue was obtained under local anesthesia by liposuction aspirates protocol. The lipoaspirate was washed with PBS to remove tissue debris. 100mL PBS containing 0.1% w/v collagenase A type I was added to isolated tissue and then incubated at 37ºC for 60 minutes. Collagenase activity was neutralized using MEM medium along with 10% fetal bovine serum. Cell pellets were resuspended in culture medium after centrifugation at 2000rpm for 10 min, and then transferred to culture flasks for 72 h at 37ºC in 5% CO2 condition. The culture medium in the flasks was changed every 3 days, and cells were passaged for two times.
Flow cytometry analysis:
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
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •patients who had a documentary exposure to mustard gas in the Iran-Iraq war
- •their disease severity were as following based on spirometric: moderate 50<forced expiratory volume at one second (FEV1)<65 or severe 40<FEV1<50
- •absence of contraindications spirometry (recent myocardial ischemia (MI)
- •hemoptysis
- •cerebral arterial aneurysm or aortic
- •pulmonary embolism,
- •uncontrolled blood pressure
- •recent pneumothorax
- •no doubt surgery/recent thoracic
- •recent eye surgery, recent stroke
- •non-availability in another research study at a same time
- •no coagulation disorders
排除标准
- •the incidence of pneumonia during the study
- •the incidence of transfusion reaction
- •other medical condition (cardiovascular disease, hypertension, diabetes)
- •visiting less than 2 times
结局指标
主要结局
pulmonary function testing (PFT)
时间窗: one year
Pulmonary Function Testing (PFT) is a complete evaluation of the respiratory system including patient history, physical examinations, chest x-ray examinations, arterial blood gas analysis, and tests of pulmonary function. The primary purpose of pulmonary function testing is to identify the severity of pulmonary impairment.
次要结局
- St. George's Respiratory Questionnaire (SGRQ)(one year)
- 6 minute walk test (6MWT)(one year)
研究者
Dr. Mostafa Ghanei
pulmonologist doctor
Baqiyatallah Medical Sciences University