Learn about Research & Clinical Trials

A Study on Pneumoconiosis Treated With Whole-lung Lavage Combined With Mesenchymal Stem Cells

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 70 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Male or female, 18-70 years old. 2. Subjects had exposed to dusts with a long history. 3. Subjects with a clear clinical diagnosis to be silicotics or coal miners' pneumoconiosis patients. 4. Subjects with each detected index of pulmonary function test including FVC, FEV1 or MVV had exceeded 70% of the predicated value. 5. Subjects signed informed consent.

Exclusion Criteria:

1. Women of childbearing age at the stage of pregnancy or lactation, or those without taking effective contraceptive measures. 2. Subjects with syphilis or HIV positive antibody. 3. Subjects with infection aggravated within the past month. 4. Subjects suffering from any of the following pulmonary diseases: active tuberculosis, pulmonary embolism, pneumothorax, multiple huge bullae, uncontrolled asthma, severe pneumonia, acute exacerbation of chronic bronchitis, AECOPD, severe and / or extremely severe COPD, etc.. 5. Subjects suffering from other serious diseases, such as myocardial infarction, unstable angina, cirrhosis, and acute glomerulonephritis. 6. Subjects suffering from other life-threatening diseases with an estimated life-span less than 2 years. 7. Subjects with leukopenia (WBC less than 4x109 / L) or agranulocytosis (WBC less than 1.5x109 / L or neutrophils less than 0.5x109 / L) caused by any reason. 8. Subjects with severe renal impairment, serum creatinine> 1.5 times the upper limit of normal. 9. Subjects with liver disease or liver damage: ALT, AST, total bilirubin> 2 times the upper limit of normal 10. Subjects with a history of mental illness or suicide risk, with a history of epilepsy or other central nervous system disorders. 11. Subjects with severe arrhythmias (such as ventricular tachycardia, frequent superventricular tachycardia, atrial fibrillation, and atrial flutter, etc.) or cardiac degree II or above conduction abnormalities displayed via 12-lead ECG. 12. Subjects with a history of alcohol or illicit drug abuse. 13. Subjects accepted by any other clinical trials within 3 months before the enrollment. 14. Subjects with poor compliance, difficult to complete the study. 15. Any other conditions that might increase the risk of subjects or interfere with the clinical trial. 16. Subjects accepted large volume whole-lung lavage treatment previously.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT02668068
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Jianwu Dai
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	JianWu Dai, Ph.DWei Xiong, M.DXiaotian Dai,, M.MYingming Zhang, M.MShencun Fang, M.M
Principal Investigator Affiliation	Chinese Academy of SciencesFirst Affiliated Hospital of the Third Military University, PLA (Southwest Hospital)First Affiliated Hospital of the Third Military University, PLA (Southwest Hospital)Nanjing Chest HospitalNanjing Chest Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Pneumoconiosis

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.