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

NCT02668068 | Completed Phase 1

• 1 other identifier: CAS-XDA-SH/NCH/IGDB
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

Pneumoconiosis

Keywords

Pneumoconiosis; Mesenchymal Stem Cells; whole-lung lavage (WLL)

Outcome Measures

Primary Outcomes (2)

• Incidence of Treatment-Emergent Adverse Events (Safety Evaluation)

  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.

  6 months

• Imaging indicator: Quantitative analysis of CT density histograms

  6 months after surgery

Secondary Outcomes (10)

• Clinical Indicator 1: change in blood gas analysis

  6 months

• Clinical Indicator 2: change in MRC chronic dyspnea scale

  6 months

• Clinical Indicator 3: change in St. George's Respiratory Questionnaire (SGRQ) scale

  6 months

• Immunological Indicator in serum : response level of CD4+ T lymphocyte subsets (Th1/Th2/Th17)

  6 months

• Immunological Indicator in lavage fluid : response level of CD4+ T lymphocyte subsets (Th1/Th2/Th17)

  6 months

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Large volume whole-lung lavage (WLL) only

Procedure: large volume whole-lung lavage (WLL)

Experimental Group

EXPERIMENTAL

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

Procedure: large volume whole-lung lavage (WLL); Biological: clinical grade umbilical cord mesenchymal stem cells

Interventions

large volume whole-lung lavage (WLL) PROCEDURE

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

Control Group; Experimental Group

clinical grade umbilical cord mesenchymal stem cells BIOLOGICAL

10\^6 (1 million) /Kg/person cells of clinical grade umbilical cord MSCs will be injected after whole-lung lavage

Experimental Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Women of childbearing age at the stage of pregnancy or lactation, or those without taking effective contraceptive measures.
• Subjects with syphilis or HIV positive antibody.
• Subjects with infection aggravated within the past month.
• 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..
• Subjects suffering from other serious diseases, such as myocardial infarction, unstable angina, cirrhosis, and acute glomerulonephritis.
• Subjects suffering from other life-threatening diseases with an estimated life-span less than 2 years.
• 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.
• Subjects with severe renal impairment, serum creatinine\> 1.5 times the upper limit of normal.
• Subjects with liver disease or liver damage: ALT, AST, total bilirubin\> 2 times the upper limit of normal
• Subjects with a history of mental illness or suicide risk, with a history of epilepsy or other central nervous system disorders.
• 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.
• Subjects with a history of alcohol or illicit drug abuse.
• Subjects accepted by any other clinical trials within 3 months before the enrollment.
• Subjects with poor compliance, difficult to complete the study.
• Any other conditions that might increase the risk of subjects or interfere with the clinical trial.

Sponsors & Collaborators

• Jianwu Dai: lead
• Southwest Hospital, China: collaborator
• Nanjing Chest Hospital: collaborator

Study Sites (2)

First Affiliated Hospital of the Third Military University, PLA (Southwest Hospital)

Chongqing, Chongqing Municipality, 400038, China

Location

Nanjing Chest Hosptial

Nanjing, Jiangsu, 210029, China

Location

MeSH Terms

Conditions

Pneumoconiosis

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Lung Injury; Occupational Diseases

Study Officials

• JianWu Dai, Ph.D

  Chinese Academy of Sciences

  PRINCIPAL INVESTIGATOR

• Wei Xiong, M.D

  First Affiliated Hospital of the Third Military University, PLA (Southwest Hospital)

  STUDY CHAIR

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator of Regenerative Medicine Laboratory, Institute of Genetics and Developmental Biology, CAS

Study Record Dates

• First Submitted: January 20, 2016
• First Posted: January 29, 2016
• Study Start: January 1, 2016
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: July 24, 2019

Record last verified: 2018-07

Locations

CN (2)