Pneumoconiosis is a kind of lung disease due to inhalation of dust such as silica(common named Silicosis), coal and rock dust, characterized by inflammation, coughing, and fibrosis. Currently there is no effective drug treatment. The whole-lung lavage(WLL) can effectively clear the protein-like substances and inhaled dust deposited in the alveoli and bronchioles, as well as the pulmonary alveolar macrophage(PAM) and the resulting induced inflammation, fibrosis induced factor, serve to improve respiratory function, relieve symptoms of efficacy, but can't slow down or reverse the progression of pulmonary fibrosis. By taking large volume whole-lung lavage (WLL) as a conventional therapy, this study intends to observe and evaluate the safety and efficiency of combined large volume WLL with mesenchymal stem cell (MSC) transplantation for treatment of Pneumoconiosis. Moreover, the immune regulation effect between large volume WLL and combined large volume WLL with MSC transplantation will also be preliminarily investigated and discussed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
80
Generally 1000 \~ 2000ml each time, 14 \~ 10 times totally, each side of the lung to 20 \~ 15 liters, until the lavage fluid from the black into a colorless clear clarification
10\^6 (1 million) /Kg/person cells of clinical grade umbilical cord MSCs will be injected after whole-lung lavage
First Affiliated Hospital of the Third Military University, PLA (Southwest Hospital)
Chongqing, Chongqing Municipality, China
Nanjing Chest Hosptial
Nanjing, Jiangsu, China
Incidence of Treatment-Emergent Adverse Events (Safety Evaluation)
Clinical adverse events evaluated as definitely/ probably/possibly concerned with large volume lung lavage and / or mesenchymal stem cell therapy in this trial, and abnormal results of laboratory tests or other special examinations will be observed and recorded in detail.
Time frame: 6 months
Imaging indicator: Quantitative analysis of CT density histograms
Time frame: 6 months after surgery
Clinical Indicator 1: change in blood gas analysis
Including PH, PaCO2,PaO2, HCO3
Time frame: 6 months
Clinical Indicator 2: change in MRC chronic dyspnea scale
Time frame: 6 months
Clinical Indicator 3: change in St. George's Respiratory Questionnaire (SGRQ) scale
Time frame: 6 months
Immunological Indicator in serum : response level of CD4+ T lymphocyte subsets (Th1/Th2/Th17)
Time frame: 6 months
Immunological Indicator in lavage fluid : response level of CD4+ T lymphocyte subsets (Th1/Th2/Th17)
Time frame: 6 months
Immunological Indicator in serum : expression levels of various cytokines including TNF-α, IL1-β, MIP-1α, TIMP1, PDGF
Time frame: 6 months
Immunological Indicator in lavage fluid: expression levels of various cytokines including TNF-α, IL1-β, MIP-1α, TIMP1, PDGF
Time frame: 6 months
Fibrosis Indicators in serum: expression levels of TGF-β1, hydroxyproline, MMP2, MMP9
Time frame: 6 months
Fibrosis Indicators in lavage fluid: expression levels of TGF-β1, hydroxyproline, MMP2, MMP9
Time frame: 6 months
self-evaluation
Self-evaluation will be also classified into four levels: effective, improved, stable and invalid
Time frame: 6 months
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