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| Name | Class |
|---|---|
| Southwest Hospital, China | OTHER |
| Nanjing Chest Hospital | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Active Comparator | Large volume whole-lung lavage (WLL) only |
|
| Experimental Group | Experimental | Combined large volume WLL with clinical grade umbilical cord mesenchymal stem cells transplantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| large volume whole-lung lavage (WLL) | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Imaging indicator: Quantitative analysis of CT density histograms | 6 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Indicator 1: change in blood gas analysis | Including PH, PaCO2,PaO2, HCO3 | 6 months |
| Clinical Indicator 2: change in MRC chronic dyspnea scale | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| JianWu Dai, Ph.D | Chinese Academy of Sciences | Principal Investigator |
| Wei Xiong, M.D | First Affiliated Hospital of the Third Military University, PLA (Southwest Hospital) | Study Chair |
| Xiaotian Dai,, M.M | First Affiliated Hospital of the Third Military University, PLA (Southwest Hospital) | Study Director |
| Yingming Zhang, M.M | Nanjing Chest Hospital | Study Director |
| Shencun Fang, M.M | Nanjing Chest Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of the Third Military University, PLA (Southwest Hospital) | Chongqing | Chongqing Municipality | 400038 | China | ||
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| ID | Term |
|---|---|
| D011009 | Pneumoconiosis |
| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D055370 | Lung Injury |
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| clinical grade umbilical cord mesenchymal stem cells | Biological | 10^6 (1 million) /Kg/person cells of clinical grade umbilical cord MSCs will be injected after whole-lung lavage |
|
| Clinical Indicator 3: change in St. George's Respiratory Questionnaire (SGRQ) scale | 6 months |
| Immunological Indicator in serum : response level of CD4+ T lymphocyte subsets (Th1/Th2/Th17) | 6 months |
| Immunological Indicator in lavage fluid : response level of CD4+ T lymphocyte subsets (Th1/Th2/Th17) | 6 months |
| Immunological Indicator in serum : expression levels of various cytokines including TNF-α, IL1-β, MIP-1α, TIMP1, PDGF | 6 months |
| Immunological Indicator in lavage fluid: expression levels of various cytokines including TNF-α, IL1-β, MIP-1α, TIMP1, PDGF | 6 months |
| Fibrosis Indicators in serum: expression levels of TGF-β1, hydroxyproline, MMP2, MMP9 | 6 months |
| Fibrosis Indicators in lavage fluid: expression levels of TGF-β1, hydroxyproline, MMP2, MMP9 | 6 months |
| self-evaluation | Self-evaluation will be also classified into four levels: effective, improved, stable and invalid | 6 months |
| Nanjing Chest Hosptial |
| Nanjing |
| Jiangsu |
| 210029 |
| China |
| D009784 |
| Occupational Diseases |