Patient recruitment

Patient recruitment

Recruitment telephone: 13651613710
Selection criteria:

Interstitial lung disease (including idiopathic pulmonary fibrosis)

(Special attention: patients with autoimmune diseases, rheumatism, connective tissue disease are not suitable for autologous stem cell therapy and will not be included in this clinical study)

 

Diagnostic criteria:

 

According to the 2011 ATS/ERS/JPS/ALAT diagnostic criteria, the diagnosis was made according to the symptoms of dry cough and shortness of breath, combined with imaging (reticular shadows in the surrounding lung area, mainly occurring in the basal part of the lung) and the characteristics of pulmonary function (restrictive ventilation dysfunction).

 

Inclusion criteria:

(1) Gender is not limited, age 50-75 years old;

(2) The diffuse function (DLCO) in the pulmonary function test is 30%~79% of the predicted value; FVC is more than 50% of the predicted value;

(3) HRCT has typical imaging findings of pulmonary fibrosis in the past 12 months;

(4) Patients who can tolerate fiberoptic bronchoscopy;

(5) Fully informed of the purpose, method and possible discomfort of the test, agree to participate in the test, and sign the informed consent form;

(6) Good compliance, willing to use drugs according to the requirements of the program and follow-up examination on time;

(7) Can understand and complete the operation of pulmonary function examination.

 

Exclusion criteria:

(1) Intolerance to cell therapy;

(2) Women of childbearing age who are pregnant, breastfeeding or who have not taken effective contraceptive measures;

(3) The positive results of any test for Treponema pallidum antibody (TP-Ab), human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) and hepatitis C virus (HCV) antibody;

(4) Patients with various malignant tumors or having a history of malignant tumors;

(5) Long-term use of amiodarone and other drugs that may cause pulmonary fibrosis before enrollment (>1 week);

(6) Before cell transplantation, there are pulmonary or other site infections requiring intravenous drug therapy, including bacterial and viral infections.

(7) A history of invasive or non-invasive mechanical ventilation within 4 weeks;

(8) Patients have any of the following lung diseases: asthma, active pulmonary tuberculosis, pulmonary embolism, pneumothorax, pulmonary hypertension, pneumoconiosis; lung cancer, obliterative bronchiolitis or other active pulmonary diseases; currently suffering from pneumonia within 4 weeks; a history of pulmonary resection, or lung volume reduction surgery within 12 months prior to screening; long-term oxygen therapy (oxygen therapy time > 15 h/d) or mechanical ventilation were used;

(9) suffering from other serious systemic diseases, such as myocardial infarction, unstable angina, liver cirrhosis, acute glomerulonephritis, connective tissue disease, etc.;

(10) Patients with leukopenia (leukopenia < 4 *109/L) or agranulocytosis (leukopenia < 1.5 *109/L or neutrophil < 0.5 *109/L) caused by any reasons;

(11) Patients with severe renal impairment, serum creatinine > 2.5 times the upper limit of normal value;

(12) Patients with Liver disease or liver function damage: ALT, AST, total bilirubin > 2.5 times the upper limit of normal value;

(13) Those with a history of mental illness or suicide risk, have a history of epilepsy or central nervous system diseases;

(14) 12-lead ECG showed severe arrhythmias (such as ventricular tachycardia, frequent supraventricular tachycardia, atrial fibrillation, atrial flutter, etc.) or conduction abnormalities of degree II or above.

(15) A history of alcohol or illicit drug abuse;

(16) Those who are allergic to cattle products;

(17) Subjects who have received any other clinical trials within three months before admission;

(18) Poor compliance, it is difficult to complete the researcher;

(19) Any situation which researchers believe that increases the risk of subjects or interferes with clinical trials;

(20) Researchers, collaborative researchers, research coordinators, researchers participating in the study, employees of research centers or family members of the above-mentioned personnel (all should not participate in relevant clinical trials to ensure the objectivity of the study);

(21) Patients with acute exacerbation of COPD or hospitalization for other respiratory diseases for 3 or more times in the past year.

(22) Those who took or planned to continue taking Nidanib within one month;

(23) Those who have received various types of allogeneic cell transplantation in the past, and those who have received organ transplantation;

(24) The researcher judged that the expected survival period may be less than one year;

(25) HRCT showed typical grid shadow or honeycomb lesions in the left and right upper lungs or HRCT showed typical grid shadow or honeycomb lesions involving more than 2/3 of the total lung.


Bronchiectasia

Diagnostic criteria:

(1) A history of repeated purulent sputum and hemoptysis;

(2) A history of respiratory infections that have previously induced bronchodilation;

(3) HRCT showed abnormal imaging changes in bronchiectasis.

 

Inclusion criteria:

(1) 40 to 75 years old, male or female;

(2) Moderate or severe reduction of diffuse function (DLCO) in pulmonary function tests;

(3) Pulmonary CT examination has imaging findings of interstitial pneumonia for disease evaluation;

(4) Fully informed of the purpose, method and possible discomfort of the test, agree to participate in the test, and sign the informed consent form;

(5) Good compliance, willing to use drugs according to the requirements of the program and follow-up examination on time;

(6) Can understand and complete the operation of pulmonary function examination.

 

Exclusion criteria:

(1) Women of childbearing age who are pregnant, breastfeeding or who have not taken effective contraceptive measures;

(2) Syphilis and HIV antibody positive;

(3) Rheumatic diseases;

(4) suffering from various malignant tumors;

(5) suffering from any of the following pulmonary diseases: active pulmonary tuberculosis, pulmonary embolism, pneumothorax, multiple giant bullae, uncontrolled asthma, severe COPD, etc;

(6) suffering from other serious systemic diseases such as diabetes (poor glycemic control), myocardial infarction, unstable angina, cirrhosis, acute glomerulonephritis, etc;

(7) Patients with leukopenia (leukopenia < 4 *109/L) or agranulocytosis (leukopenia < 1.5 *109/L or neutrophil < 0.5 *109/L) caused by any reasons;

(8) suffering from severe renal impairment, serum creatinine > 1.5 times the upper limit of normal;

(9) suffering from liver disease or liver function damage: ALT, AST, total bilirubin > 2 times the upper limit of normal;

(10) Those who have a history of mental illness or suicide risk, have a history of epilepsy or other medical history of central nervous system diseases;

(11) 12-lead ECG showed severe arrhythmias (such as ventricular tachycardia, frequent supraventricular tachycardia, atrial fibrillation, atrial flutter, etc.) or conduction abnormalities of degree II or above;

(12) A history of alcohol or illicit drug abuse;

(13) Subjects who have received any other clinical trials within three months before admission;

(14) Poor compliance, it is difficult to complete the researcher;

(15) Any situation which researchers believe that increases the risk of subjects or interferes with clinical trials.


Chronic obstructive pulmonary disease (emphysema, chronic bronchitis)

Diagnostic criteria:

(1) Age over or equal to 40 years old, chronic cough, expectoration and other symptoms, progressive exacerbation of dyspnea, and history of exposure to COPD risk factors;

(2) (2) Pulmonary function test showed airflow limitation (FEV1 < 80% predicted value, FEV1 / FVC < 0.7)

(3) CT imaging and hematological examination excluded other pulmonary diseases.

 

Inclusion criteria:

(1) Gender is not limited, age 40 to 75 years old;

a) All patients must be diagnosed as COPD and meet the following criteria: relatively stable airway obstruction obstruction, FEV1 < 80% of the predicted normal value after bronchiectasis, FEV1 / FVC < 0.7 after bronchiectasis;

(2) The diffusion function (DLCO) in the pulmonary function test needs to be less than 60% of the expected value;

(3) Subjects have smoking history of not less than 10 packs per year or smoking more than 10 years, including those who have quit smoking;

(4) Regular use of chronic obstructive pulmonary disease routine drug treatment for more than 3 months, and the condition is stable for more than 4 weeks;

(5) Patients who can tolerate fiberoptic bronchoscopy;

(6) Sign informed consent voluntarily.

 

Exclusion criteria:

(1) never smokers;

(2) women of childbearing age who are pregnant, breast-feeding or who have not taken effective contraceptive measures;

(3) The positive results of any test for Treponema pallidum antibody (TP-Ab), human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) and hepatitis C virus (HCV) antibody;

(4) Patients with various malignant tumors or having a history of malignant tumors;

(5) Before cell transplantation, there are pulmonary or other site infections requiring intravenous drug therapy, including bacterial and viral infections.

(6) A history of invasive or non-invasive mechanical ventilation within 4 weeks;

(7) Patients have any of the following lung diseases: asthma, active tuberculosis, bronchiectasis, pulmonary embolism, pneumothorax, sarcoidosis, pulmonary hypertension, interstitial pulmonary disease, cystic fibrosis, bronchiolitis obliterans or other active pulmonary diseases; acute exacerbation of pneumonia and/or moderate or severe COPD present or within 4 weeks; a history of pulmonary resection, or lung volume reduction surgery within 12 months prior to screening; long-term oxygen therapy (oxygen therapy time > 15 h/d) or mechanical ventilation were used; Antitryptase deficiency;

(8) Patients with other serious systemic diseases such as myocardial infarction, unstable angina, cirrhosis, acute glomerulonephritis, etc.

(9) Subjects with leukopenia (leukopenia < 4 *109/L) or agranulocytosis (leukopenia < 1.5 *109/L or neutrophil < 0.5 *109/L) caused by any reasons;

(10) Patients with severe renal impairment, serum creatinine > 1.5 times the upper limit of normal value;

(11) Patients with Liver disease or liver function damage: ALT, AST, total bilirubin > 2 times the upper limit of normal value;

(12) Those with a history of mental illness or suicide risk, have a history of epilepsy or central nervous system diseases;

(13) 12-lead ECG showed severe arrhythmias (such as ventricular tachycardia, frequent supraventricular tachycardia, atrial fibrillation, atrial flutter, etc.) or conduction abnormalities of degree II or above.

(14) A history of alcohol or illicit drug abuse;

(15) Those who are allergic to cattle products;

(16) Subjects who have received any other clinical trials within three months before admission;

(17) Poor compliance, it is difficult to complete the researcher;

(18) Any situation which researchers believe that increases the risk of subjects or interferes with clinical trials;

(19) Researchers, collaborative researchers, research coordinators, researchers participating in the study, employees of research centers or family members of the above-mentioned personnel (all should not participate in relevant clinical trials to ensure the objectivity of the study);

(20) Patients with acute exacerbation of COPD or hospitalization for other respiratory diseases for 3 or more times in the past year.

Contact information:

Please record the medical records (including: pulmonary function diffusion report, CT diagnosis and film, discharge records, etc.) into a compressed package and rename it as "date of the day - patient name - disease - telephone" such as "2018.05.01- Zhang San - Interstitial Lung Disease - 13012345678" sent to the clinical mailbox:clinical@regend.cn

Please contact the company's clinical project coordinator, and the coordinator and specialist will jointly judge whether you meet the inclusion criteria.