Clinical Study of the Efficacy and Safety of the Application of Allogeneic Mesenchymal (Stromal)...
Pulmonary EmphysemaActively developing stem cells (SCs) transplantation techniques cause natural interest to the problem of regeneration in the lungs. Numerous experimental studies proved the benefits of different types of SCs in experimental models of pulmonary emphysema (PE). G. Zhen et al. have shown that the transplantation of mesenchymal stem cells (MSCs) to rats with papain-induced emphysema leads to their migration into the lungs, differentiation into type 2 alveolocytes, and inhibition of apoptosis and prevention PE. K. Schweitzer et al. have proved the activity of inflammation in the airways, alveolocytes and endothelial cells apoptosis decreased after adipose SCs intravenous administration to mice with emphysema caused by chronic exposure to tobacco smoke or VEGF receptors blockade. The study of E.P. Ingenito et al. found that endobronchial installed MSCs engraft into the alveolar wall and peribronchial interstitium and release integrins, extracellular matrix components (collagen IV, laminin and fibrillin), platelet-derived growth factor receptor and transforming growth factor β2. Our study also found reliable deterrent effect of allogeneic bone marrow MSCs on the development of elastase-induced emphysema in rats at different terms of transplantation. After the success of pilot studies have started clinical trials. Currently, the website http://www. ClinicalTrials.gov reported three studies evaluating the efficacy and safety of MSC transplantation in patients with COPD and emphysema. Two of them have already been completed and the results of the first pilot project published. Authors on the example of 4 patients showed a complete absence of adverse effects, improved quality of life and stability of functional parameters at 12 months after starting treatment One of the problems of MSC transplantation in patients with respiratory failure is an accelerated apoptosis of transplanted cells under the influence of proinflammatory cytokines and oxidative stress. Since it is proved that preconditioning MSCs under hypoxia increases their survival in hypoxic conditions, increases the expression of growth factors and antiinflammatory cytokines, we suppose that MSCs grown in hypoxic medium may have a significant positive effect on the disease.
TruFreeze™ Airway Obstruction: TAO STUDY
Lung Disease AirwaysLung Diseases4 moreThe purpose of this study is to prospectively assess the efficacy and safety of spray cryotherapy ablation with the truFreeze System in conjunction with mechanical dilation or debridement for the treatment of clinically significant obstructions of the central airways. The primary effectiveness endpoint is the proportion of subjects with a minimum of 25% improvement in luminal patency following SCT treatment and mechanical intervention 30 days (+/- 5 days) following treatment. Additionally, a primary clinical safety endpoint is the reporting of all adverse events.
Assessment of Emphysema Using 1.5T MRI With UTE Pulse Sequences
EmphysemaEmphysema is a major pathological feature of Chronic Obstructive Pulmonary Disease (COPD). Non-invasive assessment of emphysema is a crucial issue for the phenotype and follow-up of COPD patients. Currently, CT is the method of reference to evaluate and quantify emphysema but it remains a radiation-based technique. Magnetic Resonance Imagery (MRI) with ultrashort echo time (UTE) pulse sequences is a promising non-ionizing alternative for lung imaging. Our objective is to evaluate emphysema in COPD patients using CT and MR-UTE, and to test the agreement between both techniques.
eRT Remote Health Monitoring
Pulmonary DiseaseChronic Obstructive5 moreRemote Health Monitoring (RHM) is the assessment of one's own symptoms at home between doctor visits, using things like at-home breathing tests, electronic diaries to answer questionnaires, and other monitoring devices. The hypothesis of this study is that the health and quality of life of people with COPD who do RHM for one year will be better than people with COPD who do not do RHM. Subjects who are at least 40 years old, have been diagnosed with chronic obstructive pulmonary disease (COPD), also known as chronic bronchitis or emphysema, and are current or former smokers will be invited to participate. This study is paid for by eResearch Technology (eRT). Subjects will complete 2 visits at UCLA, separated by one year of RHM. All subjects will participate in RHM. RHM will involve daily monitoring at home using a few electronic devices: blood oxygen levels, symptoms, medication use, breathing tests, and activity monitoring. Visits will include physical exam and medical history, ECG, questionnaires, breathing tests, and exercise tests.
Sequential Endoscopic Lung Volume Reduction
EmphysemaCOPDPatients with heterogenous emphysema benefits from endoscopic lung volume reduction. Until now the technique is limited to one lobe. In case of collateral ventilation patients show no improvement. Between upper and middle lobe exists the highest collateral flow. The trial examine the hypothesis, that sequential ELVR help especially those patients, which have no benefit after lobar exclusion.
A Study of RYMPHYSIA for Alpha1-Proteinase Inhibitor (A1PI) Therapy in Adults With A1PI Deficiency...
Chronic Obstructive Pulmonary Disease (COPD)Alpha1-Antitrypsin DeficiencyThe main purpose of this study is to evaluate the efficacy of RYMPHYSIA [Alpha1-Proteinase Inhibitor (Human)] compared to another available alpha-1 proteinase Inhibitor (A1PI) in adults with A1PI deficiency and COPD-emphysema. In Part A of the study, participants will be randomly assigned to receive either RYMPHYSIA or another available A1PI for 104 weeks. Participants who were randomized to another available A1PI will enter a 2-week follow-up period after the treatment phase is completed; participants who were randomized to RYMPHYSIA will enter Part B. In Part B, participants will be randomly assigned to one of two groups and will receive either the same dose of RYMPHYSIA as in Part A or a different dose for an additional 104 weeks, followed by a 2-week follow-up period.
EMPHYSEMA AND FLNA MUTATION
EmphysemaSome sparse scientific data support the hypothesis that otherwise unexplained emphysema may be associated with FLNA mutation. This prospective, monocentric, cross-sectional study aimed to describe the frequency of emphysema in patients carrying an FLNA mutation. Patients with FLNA mutations who accept the study will benefit from a chest physician's clinical examination, respiratory function tests and a chest scan. The primary endpoint is to describe emphysema's frequency in patients carrying FLNA mutation. The other objectives are to describe emphysema's features in these patients and to describe their lung function abnormalities. The final goal is to confirm the association between unexplained emphysema and FLNA mutation.
Exploring Novel Biomarkers for Emphysema Detection
CopdEmphysemaThe goal of this clinical trial is to evaluate whether voice or capnometry, alone or in combination with other (non invasive) biomarkers can be used to detect emphysema on chest CT-scan in people with chronic obstructive pulmonary disease (COPD). The main question it aims to answer is: • Can a machine-learning based algorithm be developed that can classify the extent of emphysema on chest CT scan from patients with COPD, based on voice and/or capnometry. Participants will: perform different voice-related tasks perform capnometry twice (before/after exercise) perform a light exercise task between tasks ( 5-sit-to-stand test) undergo one venipuncture
Crossover Blinded Trial of Cell Therapy Versus Placebo in COPD
COPDEmphysema or COPD1 moreThe aim of this randomized, controlled crossover designed study is to compare the outcomes of receiving autologous, adult stem cells versus placebo among participants with chronic obstructive pulmonary disease (COPD). The study is limited to self-funded participants with a diagnosis of COPD. The study, along with others at the Lung Institute, have received full review and approval of an Institutional Review Board.
Activity Monitor Use in COPD Patients Undergoing Rehabilitation
Chronic Obstructive Pulmonary DiseaseCOPD2 moreIn patients with Chronic Obstructive Pulmonary Disease (COPD) lifestyles with lower physical activity levels have been shown to increase the risk of hospital admissions and shorten survival rates. An established process in increasing activity levels is to undergo pulmonary rehabilitation classes. The investigators wish to identify whether the use of activity monitors,which will provide feedback on activity levels, will increase the physical activity levels of patients with COPD outside of the supervised pulmonary rehabilitation sessions.