A Study on Pneumoconiosis Treated With Whole-lung Lavage Combined With Mesenchymal Stem Cells
NCT02668068 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2019-07-24
Summary
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.
Conditions
- Pneumoconiosis
Interventions
- PROCEDURE
-
large volume whole-lung lavage (WLL)
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
- BIOLOGICAL
-
clinical grade umbilical cord mesenchymal stem cells
10\^6 (1 million) /Kg/person cells of clinical grade umbilical cord MSCs will be injected after whole-lung lavage
Sponsors & Collaborators
-
Southwest Hospital, China
collaborator OTHER -
Nanjing Chest Hospital
collaborator UNKNOWN -
Jianwu Dai
lead OTHER_GOV
Principal Investigators
-
JianWu Dai, Ph.D · Chinese Academy of Sciences
-
Wei Xiong, M.D · First Affiliated Hospital of the Third Military University, PLA (Southwest Hospital)
-
Xiaotian Dai,, M.M · First Affiliated Hospital of the Third Military University, PLA (Southwest Hospital)
-
Yingming Zhang, M.M · Nanjing Chest Hospital
-
Shencun Fang, M.M · Nanjing Chest Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-01-31
- Primary Completion
- 2019-03-31
- Completion
- 2019-03-31
Countries
- China
Study Locations
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