ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02668068
Recruitment Status : Active, not recruiting
First Posted : January 29, 2016
Last Update Posted : July 18, 2018
Sponsor:
Collaborators:
Southwest Hospital, China
Nanjing Chest Hospital
Information provided by (Responsible Party):
Jianwu Dai, Chinese Academy of Sciences

Brief 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.


Condition or disease Intervention/treatment Phase
Pneumoconiosis Procedure: large volume whole-lung lavage (WLL) Biological: clinical grade umbilical cord mesenchymal stem cells Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Study Start Date : January 2016
Estimated Primary Completion Date : December 30, 2018
Estimated Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Control Group
Large volume whole-lung lavage (WLL) only
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

Experimental: Experimental Group
Combined large volume WLL with clinical grade umbilical cord mesenchymal stem cells transplantation
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




Primary Outcome Measures :
  1. 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.

  2. Imaging indicator: Quantitative analysis of CT density histograms [ Time Frame: 6 months after surgery ]

Secondary Outcome Measures :
  1. Clinical Indicator 1: change in blood gas analysis [ Time Frame: 6 months ]
    Including PH, PaCO2,PaO2, HCO3

  2. Clinical Indicator 2: change in MRC chronic dyspnea scale [ Time Frame: 6 months ]
  3. Clinical Indicator 3: change in St. George's Respiratory Questionnaire (SGRQ) scale [ Time Frame: 6 months ]
  4. Immunological Indicator in serum : response level of CD4+ T lymphocyte subsets (Th1/Th2/Th17) [ Time Frame: 6 months ]
  5. Immunological Indicator in lavage fluid : response level of CD4+ T lymphocyte subsets (Th1/Th2/Th17) [ Time Frame: 6 months ]
  6. Immunological Indicator in serum : expression levels of various cytokines including TNF-α, IL1-β, MIP-1α, TIMP1, PDGF [ Time Frame: 6 months ]
  7. Immunological Indicator in lavage fluid: expression levels of various cytokines including TNF-α, IL1-β, MIP-1α, TIMP1, PDGF [ Time Frame: 6 months ]
  8. Fibrosis Indicators in serum: expression levels of TGF-β1, hydroxyproline, MMP2, MMP9 [ Time Frame: 6 months ]
  9. Fibrosis Indicators in lavage fluid: expression levels of TGF-β1, hydroxyproline, MMP2, MMP9 [ Time Frame: 6 months ]
  10. self-evaluation [ Time Frame: 6 months ]
    Self-evaluation will be also classified into four levels: effective, improved, stable and invalid



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02668068


Locations
China, Chongqing
First Affiliated Hospital of the Third Military University, PLA (Southwest Hospital)
Chongqing, Chongqing, China, 400038
China, Jiangsu
Nanjing Chest Hosptial
Nanjing, Jiangsu, China, 210029
Sponsors and Collaborators
Jianwu Dai
Southwest Hospital, China
Nanjing Chest Hospital
Investigators
Principal Investigator: JianWu Dai, Ph.D Chinese Academy of Sciences
Study Chair: Wei Xiong, M.D First Affiliated Hospital of the Third Military University, PLA (Southwest Hospital)
Study Director: 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

Responsible Party: Jianwu Dai, Principal Investigator of Regenerative Medicine Laboratory, Institute of Genetics and Developmental Biology, CAS, Chinese Academy of Sciences
ClinicalTrials.gov Identifier: NCT02668068     History of Changes
Other Study ID Numbers: CAS-XDA-SH/NCH/IGDB
First Posted: January 29, 2016    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: July 2018

Keywords provided by Jianwu Dai, Chinese Academy of Sciences:
Pneumoconiosis
Mesenchymal Stem Cells
whole-lung lavage (WLL)

Additional relevant MeSH terms:
Pneumoconiosis
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Lung Injury
Occupational Diseases