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PneumoconiosisPhase 1NCT02668068

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

A Phase 1 study testing large volume whole-lung lavage (WLL) and clinical grade umbilical cord mesenchymal stem cells in people with Pneumoconiosis, run by Jianwu Dai at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Pneumoconiosis
What is being tested?
large volume whole-lung lavage (WLL) and clinical grade umbilical cord mesenchymal stem cells
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
2 sitesChina
Study dates
Jan 2016to Mar 2019
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.
  • Subjects accepted large volume whole-lung lavage treatment previously.

Trial locations and contacts

2 sites in 1 country.

China2 sites

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

    Chongqing, Chongqing Municipality, 400038

  • Nanjing Chest Hosptial

    Nanjing, Jiangsu, 210029

Other trials in China

About this study

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

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
Being tested
large volume whole-lung lavage (WLL), clinical grade umbilical cord mesenchymal stem cells
Keywords
Pneumoconiosis, Mesenchymal Stem Cells, whole-lung lavage (WLL)
Medical subject headings
Pneumoconiosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • large volume whole-lung lavage (WLL)Procedure or surgery

    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

  • clinical grade umbilical cord mesenchymal stem cellsBiological

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

Study groups in NCT02668068
Study groupRoleWhat they receive
Control GroupActive comparatorLarge volume whole-lung lavage (WLL) only
Receives: Procedure: large volume whole-lung lavage (WLL)
Experimental GroupExperimentalCombined large volume WLL with clinical grade umbilical cord mesenchymal stem cells transplantation
Receives: Procedure: large volume whole-lung lavage (WLL); Biological: clinical grade umbilical cord mesenchymal stem cells

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 months

  2. Imaging indicator: Quantitative analysis of CT density histograms

    Measured: 6 months after surgery

Secondary outcomes (10)

  1. Clinical Indicator 1: change in blood gas analysis

    Including PH, PaCO2,PaO2, HCO3

    Measured: 6 months

  2. Clinical Indicator 2: change in MRC chronic dyspnea scale

    Measured: 6 months

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

    Measured: 6 months

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

    Measured: 6 months

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

    Measured: 6 months

  6. Immunological Indicator in serum : expression levels of various cytokines including TNF-α, IL1-β, MIP-1α, TIMP1, PDGF

    Measured: 6 months

  7. Immunological Indicator in lavage fluid: expression levels of various cytokines including TNF-α, IL1-β, MIP-1α, TIMP1, PDGF

    Measured: 6 months

  8. Fibrosis Indicators in serum: expression levels of TGF-β1, hydroxyproline, MMP2, MMP9

    Measured: 6 months

  9. Fibrosis Indicators in lavage fluid: expression levels of TGF-β1, hydroxyproline, MMP2, MMP9

    Measured: 6 months

  10. self-evaluation

    Self-evaluation will be also classified into four levels: effective, improved, stable and invalid

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2016 (estimated)
  2. Study startJan 2016
  3. Primary completionMar 2019
  4. Study completionMar 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02668068
Sponsor's protocol ID
CAS-XDA-SH/NCH/IGDB
Status last verified
Jul 2018
First submitted
20 Jan 2016
Last updated
24 Jul 2019
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing large volume whole-lung lavage (WLL) and clinical grade umbilical cord mesenchymal stem cells in people with Pneumoconiosis, run by Jianwu Dai at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment-Emergent Adverse Events (Safety Evaluation) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02668068.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2019.

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