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

NCT ID: NCT02668068

Last Updated: 2019-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2019-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control Group

Large volume whole-lung lavage (WLL) only

Group Type: ACTIVE_COMPARATOR

large volume whole-lung lavage (WLL)

Intervention Type: 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

Experimental Group

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

Group Type: EXPERIMENTAL

large volume whole-lung lavage (WLL)

Intervention Type: 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

clinical grade umbilical cord mesenchymal stem cells

Intervention Type: BIOLOGICAL

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

Interventions

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

Intervention Type: PROCEDURE

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

Intervention Type: BIOLOGICAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Southwest Hospital, China

OTHER

Sponsor Role: collaborator

Nanjing Chest Hospital

UNKNOWN

Sponsor Role: collaborator

Jianwu Dai

OTHER_GOV

Sponsor Role: lead

Responsible Party

Jianwu Dai

Principal Investigator of Regenerative Medicine Laboratory, Institute of Genetics and Developmental Biology, CAS

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

JianWu Dai, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Chinese Academy of Sciences

Wei Xiong, M.D

Role: STUDY_CHAIR

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

Xiaotian Dai,, M.M

Role: STUDY_DIRECTOR

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

Yingming Zhang, M.M

Role: STUDY_DIRECTOR

Nanjing Chest Hospital

Shencun Fang, M.M

Role: STUDY_DIRECTOR

Nanjing Chest Hospital

Locations

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

Chongqing, Chongqing Municipality, China

Nanjing Chest Hosptial

Nanjing, Jiangsu, China

Countries

China

Other Identifiers

CAS-XDA-SH/NCH/IGDB

Identifier Type: -

Identifier Source: org_study_id