Unicentric Study Protocol of Cell Therapy in Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Forced Vital Capacity (FVC)
研究概览
简要总结
The purpose of this study is to determine whether the cell therapy with bone marrow mononuclear cells is safe in the treatment of chronic obstructive pulmonary disease, specifically the pulmonary emphysema.
详细描述
The main feature of the pulmonary emphysema, included in range of the Chronic Obstructive Pulmonary Disease (COPD), is the airflow obstruction resulting from the destruction of the alveolar walls distal to the terminal bronchiole, without significant pulmonary fibrosis. The existing clinical approaches has contributed to the enlargement and amelioration of the emphysema patients life quality, although no effective or curative treatment has been achieved. The surgical treatment, on the other hand, involves complex procedures and, in the specific case of lung transplantation, a lack of donors.
Considering these aspects, several experimental models have been proposed aiming to increase knowledge about the pathophysiological processes and enable new clinical approaches to the pulmonary emphysema. The cell therapy, briefly described as the use of cells in disease treatment, presents itself as a promising therapeutic approach with great potential applicability in degenerative pulmonary diseases. In this way, it is intended in this project, the proposition of a protocol to evaluate the safety of cell therapy with pool of mononuclear cells from bone marrow in patients with clinical and laboratory diagnosis of pulmonary emphysema in advanced stage (stage IV dyspnea).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 72 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of severe chronic obstructive pulmonary disease
- •ineffective clinical treatment
- •limited life expectancy
- •limitations in daily physical activity
- •possibility of pulmonary rehabilitation physiotherapy
- •acceptable nutritional status
- •acceptable cardiac function
- •at least six months smoking cessation
- •family support
- •modified medical research council dyspnea scale stage > 3
排除标准
- •pulmonary or extra-pulmonary infection
- •severe coronary disease and/or ventricular dysfunction
- •significant kidney or liver disease
- •immunosuppressive disease
- •active smoker
- •psychosocial problems
- •established medical protocol
- •family rejection
- •pregnancy
研究组 & 干预措施
pre-procedure
emphysema patients evaluated prior to the stem cells infusion
干预措施: Stem cells stimulation (Drug)
pre-procedure
emphysema patients evaluated prior to the stem cells infusion
干预措施: stem cells collection (Procedure)
pre-procedure
emphysema patients evaluated prior to the stem cells infusion
干预措施: stem cells infusion (Genetic)
post-procedure
emphysema patients evaluated 30 days after the stem cells infusion
干预措施: Stem cells stimulation (Drug)
post-procedure
emphysema patients evaluated 30 days after the stem cells infusion
干预措施: stem cells collection (Procedure)
post-procedure
emphysema patients evaluated 30 days after the stem cells infusion
干预措施: stem cells infusion (Genetic)
结局指标
主要结局
Forced Vital Capacity (FVC)
时间窗: baseline and 30 days after procedure
A pulmonary function test that measures the volume and speed of the inhalated air.
Forced Expiratory Volume (FEV1)
时间窗: baseline and 30 days after procedure
A pulmonary function test that measures the volume and speed of the exhaled air.
Vital Capacity - VC
时间窗: baseline and 30 days after the procedure
A pulmonary function test that measures the volume and speed of the inhalated and exhaled air.
次要结局
- Arterial Blood Gases Test - Pa O2(baseline and 30 days after procedure)
- Arterial Blood Gases Test - Pa CO2(baseline and 30 days after the procedure)
研究者
João Tadeu Ribeiro Paes
sponsor
UPECLIN HC FM Botucatu Unesp
