Chronic obstructive pulmonary disease (COPD) is one of the most common diseases worldwide and is considered a public health problem. The World Health Organization estimates that about 210 million people have COPD. Disease-related mortality is more than 3 million, representing 5% of all deaths, 90% of this mortality being concentrated in middle- and low-income countries. COPD can be subdivided into chronic bronchitis and emphysema. Emphysema, the focus of this project, is histologically defined by the permanent increase of the distal air spaces to the terminal bronchioles associated with the destruction of the alveolar septa in the lung. Approximately two-thirds of adult men and a quarter of women (most without dysfunction) will have well-defined emphysema, but often of limited extent. Mesenchymal stem cells (MSCs) have anti-inflammatory, anti-fibrotic, microbicide and repair potential. Regarding COPD, several authors have concentrated efforts in the investigation of the relationship between the severity of the condition and the various sources of adult stem cells. Apparently the lungs have a high chemotactic effect in relation to adult stem cells, since several studies have evidenced a high implantation (6-20%) of stem cells derived from bone marrow, administered systemically, in the pulmonary tissue of receptors. Therefore, MSCs has been tested in different lung diseases have no effective treatment, such as pulmonary fibrosis, acute respiratory distress syndrome, asthma, COPD positive results, such as reduction of fibrosis, reduction of proliferation inflammatory cells and cytokines, reduction of infectious processes and recovery of the histological changes caused by pulmonary emphysema. Based on these findings, the purpose of this project is to evaluate the safety and efficacy of endoscopic administration of bone marrow stem cells in patients with severe homogeneous emphysema and evaluating the feasibility, efficacy and safety of this procedure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
34
Endoscopic lung volume reduction therapy.
Mesenchymal stem cells have anti-inflammatory, anti-fibrotic, microbicide and repair potential.
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
RECRUITINGAll-cause death
Expressed as the total number of death due to all conditions during the clinical trial.
Time frame: 6 months
Number of participants with worsening of dyspnea
Number of participants with worsening of dyspnea as measured by the mMRC-Modified Medical Research Council (1 point increase in the measured scale). The mMRC Dyspnea Scale quantifies disability attributable to breathlessness (range from 1-4), and is useful for characterizing baseline dyspnea in patients with respiratory diseases.
Time frame: 6 months
Number of participants with respiratory functional worsening
Number of participants with respiratory functional worsening as measured by decrease of 15% or more in FEV1 (forced expiratory volume in one second). FEV1 is a measurement taken from a pulmonary function test. It calculates the amount of air that a person can force out of their lungs in 1 second.
Time frame: 6 months
Impairment of exercise capacity
Impairment of exercise capacity as measured by reduction of 35 m in the 6-minute walk test. The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The test provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise.
Time frame: 6 months
Increased oxygen use
Outcome measure result: number of participants with 1 point increase in oxygen need as classification on the chart above 0 - no oxygen use 1- intermittent use \<6h/day 2- intermittent use \>6h/dia 3 - continuous oxygen use
Time frame: 6 months
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