|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT02668068 |
|
Date of registration:
|
20/01/2016 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
A Study on Pneumoconiosis Treated With Whole-lung Lavage Combined With Mesenchymal Stem Cells
|
|
Scientific 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 |
|
Date of first enrolment:
|
January 2016 |
|
Target sample size:
|
80 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02668068 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
|
|
Phase:
|
Phase 1
|
|
|
Countries of recruitment
|
|
China
| | | | | | | |
|
Contacts
|
|
Name:
|
Wei Xiong, M.D |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
First Affiliated Hospital of the Third Military University, PLA (Southwest Hospital) |
|
|
Name:
|
JianWu Dai, Ph.D |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Chinese Academy of Sciences |
|
|
Name:
|
Xiaotian Dai,, M.M |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
First Affiliated Hospital of the Third Military University, PLA (Southwest Hospital) |
|
|
Name:
|
Shencun Fang, M.M |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Nanjing Chest Hospital |
|
|
Name:
|
Yingming Zhang, M.M |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Nanjing Chest Hospital |
| |
|
Key inclusion & exclusion 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.
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Pneumoconiosis
|
|
Intervention(s)
|
|
Biological: clinical grade umbilical cord mesenchymal stem cells
|
|
Procedure: large volume whole-lung lavage (WLL)
|
|
Primary Outcome(s)
|
|
Imaging indicator: Quantitative analysis of CT density histograms
[Time Frame: 6 months after surgery]
|
|
Incidence of Treatment-Emergent Adverse Events (Safety Evaluation)
[Time Frame: 6 months]
|
|
Secondary Outcome(s)
|
|
Immunological Indicator in serum : expression levels of various cytokines including TNF-a, IL1-ß, MIP-1a, TIMP1, PDGF
[Time Frame: 6 months]
|
|
Clinical Indicator 2: change in MRC chronic dyspnea scale
[Time Frame: 6 months]
|
|
Immunological Indicator in lavage fluid: expression levels of various cytokines including TNF-a, IL1-ß, MIP-1a, TIMP1, PDGF
[Time Frame: 6 months]
|
|
Fibrosis Indicators in lavage fluid: expression levels of TGF-ß1, hydroxyproline, MMP2, MMP9
[Time Frame: 6 months]
|
|
Clinical Indicator 1: change in blood gas analysis
[Time Frame: 6 months]
|
|
Clinical Indicator 3: change in St. George's Respiratory Questionnaire (SGRQ) scale
[Time Frame: 6 months]
|
|
Fibrosis Indicators in serum: expression levels of TGF-ß1, hydroxyproline, MMP2, MMP9
[Time Frame: 6 months]
|
|
Immunological Indicator in lavage fluid : response level of CD4+ T lymphocyte subsets (Th1/Th2/Th17)
[Time Frame: 6 months]
|
|
self-evaluation
[Time Frame: 6 months]
|
|
Immunological Indicator in serum : response level of CD4+ T lymphocyte subsets (Th1/Th2/Th17)
[Time Frame: 6 months]
|
|
Secondary ID(s)
|
|
CAS-XDA-SH/NCH/IGDB
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|