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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02668068 on ClinicalTrials.gov