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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Multicenter, Randomized, Single-blind, Parallel-group Study of Combined Large Volume WLL With Clinical Grade Umbilical Cord Mesenchymal Stem Cells(MSC) Transplantation for Treatment of 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.


Detailed Summary:
Sponsor: Jianwu Dai

Current Primary Outcome:

  • Incidence of Treatment-Emergent Adverse Events (Safety Evaluation) [ Time Frame: 6 months ]
    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.
  • Imaging indicator: Quantitative analysis of CT density histograms [ Time Frame: 6 months after surgery ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Clinical Indicator 1: change in blood gas analysis [ Time Frame: 6 months ]
    Including PH, PaCO2,PaO2, HCO3
  • 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 [ Time Frame: 6 months ]
    Self-evaluation will be also classified into four levels: effective, improved, stable and invalid


Original Secondary Outcome: Same as current

Information By: Chinese Academy of Sciences

Dates:
Date Received: January 20, 2016
Date Started: January 2016
Date Completion: December 2017
Last Updated: February 7, 2017
Last Verified: January 2017